A novel enhanced cement fixation (EF) tibial implant with deeper cement pockets and a more roughened bonding surface was released to market for an existing total knee arthroplasty (TKA) system.This randomized controlled trial assessed fixation of the both the EF (ATTUNE S+) and standard (Std; ATTUNE S) using radiostereometric analysis. Overall, 50 subjects were randomized (21 EF-TKA and 23 Std-TKA in the final analysis), and had follow-up visits at six weeks, and six, 12, and 24 months to assess migration of the tibial component. Low viscosity bone cement with tobramycin was used in a standardized fashion for all subjects. Patient-reported outcome measure data was captured at preoperative and all postoperative visits.Aims
Methods
Femoral stem design affects periprosthetic bone mineral density (BMD), which may impact long term survival of cementless implants in total hip arthroplasty (THA). The aim of this study was to examine proximal femoral BMD in three morphologically different uncemented femoral stems designs to investigate whether one particular design resulted in improved preservation of BMDMethods: 119 patients were randomised to receive either a proximally coated dual taper wedge stem, a proximally coated anatomic stem or a fully coated collarless triple tapered stem. All surgeries were performed via the posterior approach with mobilization on the day of surgery. Dual energy x-ray absorptiometry scans (Lunar iDXA, GE Healthcare, Madison, WI) assessed BMD across the seven Gruen zones pre-operatively, and post-operatively at 6-weeks, 1-year, and 2-years and compared to the unoperated contralateral femur as a control. Patient reported outcome measures of pain, function and health were also included at these corresponding follow-ups. BMD increased in zones one (2.5%), two (17.1%), three (13.0%), five (10%) and six (17.9%) for all stems. Greater preservation of BMD was measured on the lateral cortex (zone 2) for both the dual taper wedge and anatomic stems (p = 0.019). The dual taper wedge stem also demonstrated preservation of BMD in the medial calcar (zone 7) whilst the anatomic and triple taper stem declined in this region, however this was not statistically significant (p = 0.059). BMD decreased on average by 2.1% inthe mid-diaphysis region, distal to the stem tip (zone 4) for all implants. All stems performed equivalently at final follow-up in all patient reported outcome measures. This study demonstrated maintenance of femoral BMD in three different cementless femoral stem designs, with all achieving excellent improvements in patient reported outcomes. There was no significant stress shielding observed, however longer follow-up is required to elucidate the impact of this finding on implant survivorship.
Wound complications following revision total hip arthroplasty (THA) are associated with an increased risk of superficial and deep infections. Closed incision negative-pressure therapy (ciNPT) has been reported to decrease this risk. This study's purpose was to assess if ciNPT decreases the rate of wound complications following revision THA versus a conventional, silver-impregnated dressing. This was a single center, randomized controlled trial of patients undergoing both septic and aseptic revision THA. Patients received either ciNPT or a silver-impregnated dressing (control) for 7 days. Wound complications within 90 days of the procedure were recorded, including: surgical site infection (SSI), periprosthetic joint infection (PJI), prolonged drainage greater than 5 days, erythema requiring antibiotics, and hematoma formation. An Introduction
Methods
Perioperative glucocorticoids have been used as a successful non-opioid analgesic adjunct for various orthopaedic procedures. Here we describe an ongoing randomized control trial assessing the efficacy of a post-operative methylprednisolone taper course on immediate post-operative pain and function following surgical distal radius fixation. We hypothesize that a post-operative methylprednisolone taper course following distal radius fracture fixation will lead to improved patient pain and function. This study is a randomized control trial (NCT03661645) of a group of patients treated surgically for distal radius fractures. Patients were randomly assigned at the time of surgery to receive intraoperative dexamethasone only or intraoperative dexamethasone followed by a 6-day oral methylprednisolone (Medrol) taper course. All patients received the same standardized perioperative pain management protocol. A pain journal was used to record visual analog pain scores (VAS-pain), VAS-nausea, and number of opioid tablets consumed during the first 7 post-operative days (POD). Patients were seen at 2-weeks, 6-weeks, and 12-weeks post-operatively for clinical evaluation and collection of patient reported outcomes (Disabilities of the Arm, Shoulder and Hand Score [qDASH]). Differences in categorical variables were assessed with χ2 or Fischer's exact tests. T-tests or Mann-Whitney-U tests were used to compare continuous data. Forty-three patients were enrolled from October 2018 to October 2019. 20 patients have been assigned to the control group and 23 patients have been assigned to the treatment group. There were no differences in age (p=0.7259), Body Mass Index (p=0.361), race (p=0.5605), smoking status (p=0.0844), or pre-operative narcotic use (p=0.2276) between cohorts. 83.7% (n=36) of patients were female and the median age was 56.9 years. No differences were seen in pre-operative qDASH (p=0.2359) or pre-operative PRWE (p=0.2329) between groups. In the 7 days following surgery, patients in the control group took an average of 16.3 (±12.02) opioid tablets, while those in the treatment group took an average of 8.71 (±7.61) tablets (p=0.0270). We see that significant difference in Opioid consumption is formed at postoperative day two between the two groups with patients in the control group taking. Patient pain scores decreased uniformly in both groups to post-operative day 7. Patient pain was not statistically from POD0 to POD2 (p=0.0662 to 0.2923). However, from POD4 to POD7 patients receiving the methylprednisolone taper course reported decreased pain (p=0.0021 to 0.0497). There was no difference in qDASH score improvement at 6 or 12 weeks. Additionally, no differences were seen for wrist motion improvement at 6 or 12 weeks. A methylprednisolone taper course shows promise in reducing acute pain in the immediate post-operative period following distal radius fixation. Furthermore, although no statistically significant reductions in post-operative opioid utilization were noted, current trends may become statistically significant as the study continues. No improvements were seen in wrist motion or qDASH and continued enrollment of patients in this clinical trial will further elucidate the role of methylprednisolone for these outcomes.
The purpose of this study is to evaluate the early outcomes with the use of a smartphone-based exercise and educational platform after primary total hip arthroplasty compared to a standard of care control group. A multicenter prospective randomized control trial was conducted evaluating the use of the mymobility smartphone-based care platform for primary total hip arthroplasty (THA). Patients randomized to the control group (198 patients) received the respective institution's standard of care. Those randomized to mymobility treatment group (167 patients) were provided an Apple Watch and mymobility smartphone application. The application provides pre and postoperative educational content, video directed exercise programs as well as tracks the patient's activity. Patients in the treatment group were not initially prescribed physical therapy, but could be if their surgeon deemed it necessary. Early outcomes assessed included 90-day hip range of motion, HOOS JR scores, 30-day single leg stance (SLS) and time up and go (TUG) test. We also evaluated PT utilization, THA complications associated with readmissions, ER visits not associated with readmissions, urgent care (non standard of care) visits, and physician office visits. Outcome scores include HOOS-Jr, EQ-5D-5L, single stance (SLS), Timed up and go (TUG). Satisfaction scores for the procedure and the mymobility study group were also recorded.Background
Methods
Tranexamic Acid (TXA) is now commonly used in major surgical operations including orthopaedics. The TRAC-24 randomised control trial aimed to assess if an additional 24 hours of TXA post – operatively in primary total hip (THA) and total knee arthroplasty (TKA) reduced blood loss. Contrary to other orthopaedic studies to date this trial included high risk patients. This paper presents the results of a cost analysis undertaken alongside this RTC. TRAC-24 was a prospective randomised controlled trial on patients undergoing TKA and THA. Three groups were included, Group 1 received 1 g intravenous (IV) TXA perioperatively and an additional 24-hour post-operative oral regime, group 2 received only the perioperative dose and group 3 did not receive TXA. Cost analysis was performed out to day 90. Group 1 was associated with the lowest mean total costs, followed by group 2 and then group 3. The difference between groups 1 and 3 −£797.77 (95% CI −1478.22, −117.32) were statistically significant. Extended oral dosing reduced costs for patients undergoing THA but not TKA. The reduced costs in groups 1 and 2 resulted from reduced length of stay, readmission rates, Accident and Emergency (A&E) attendances and blood transfusions. This study demonstrated significant cost savings when using TXA in primary THA or TKA. Extended oral dosing reduced costs further in THA but not TKA.
The capsular releasing sequence is crucial to safely conduct the Direct Anterior Approach for THA on a regular OR table. The release of the anterior capsule is the first step of the releasing sequence and allows for optimal exposure. This can be done by either resecting a part of the anterior capsule or by preserving it. Our zero hypothesis was that clinical outcomes would not be different between both techniques. 190 Patients operated between November 2017 and May 2018, met the inclusion criteria and were randomly allocated in a double blinded study to either the capsular resection (CR)(N=99) or capsular preservation (CP)(N=91) cohort. The same cementless implant was used in all cases. Patient-reported outcome measures (PROMS) were collected pre- and post-operatively at 6 weeks, 3 months and 1 year. Adverse events were recorded. Outcomes were compared with the Mann-Withney U test and a significance level of p<0,05.INTRODUCTION
MATERIALS & METHODS
The treatment of displaced femoral neck fractures in elderly patients is under debate. Hemiarthroplasty is a recognised treatment for elderly patients with reduced capacity for mobilisation. Controversy exists around cemented or uncemented implants for hemiarthroplasty in this population. The aim of this study is to investigate outcomes of cemented vs uncemented hemiarthroplasty implants to two years post operation. All elderly patients presenting to one institution with a displaced subcapital neck of femur fracture were offered inclusion. One hundred and sixty patients (mean age, 85 years) with acute displaced femoral neck fractures were randomly allocated to be treated with cemented Exeter, or uncemented Zweymüller Alloclassic Hemiarthroplasty. Clinical and radiologic follow-up to two years with the main outcome measurements being pain, mortality, mobility, complications, reoperations, and quality of life using validated scores recorded by a blinded outcome assessor.Introduction
Methods
The primary aim of this study was to undertake a cost-effectiveness analysis (CEA) of acute fixation versus conservative management of displaced midshaft clavicle fractures. The secondary aim was to conduct a sensitivity analysis of patient characteristics that may influence a threshold of £20,000 per quality-adjusted life year gained (QALY). A CEA was conducted from a randomised control trial comparing conservative management (n=92) to acute plate fixation (n=86) of displaced midshaft clavicle fractures. The incremental cost effectiveness ratio (ICER) was used to express the cost per QALY. The short form 6-dimensional (SF-6D) score was the preference based index to calculate the cost per QALY. The 12-month SF-6D advantage of acute fixation over conservative management was 0.0085 (p=0.464) with a mean cost difference of £4,096.22 and resultant ICER of £481,908.24/QALY. For a threshold of £20,000/QALY the benefit of acute fixation would need to be present for 24.1 years. Linear regression analysis identified nonunion as the only independent factor to influence the SF-6D at 12-months (p<0.001). Conservatively managed fractures that resulted in a nonunion (n=16) had a significantly worse SF-6D compared to acute fixation (0.0723, p=0.001) with comparable healthcare cost at 12-months (£170.12 difference). Modelling the ICER of acute fixation against those complicated by a nonunion proved to be cost effective at £2,352.97/QALY at 12-months. Routine plate fixation of displaced midshaft clavicle fractures is not cost-effective. Patients with nonunion after conservative management have increased morbidity with comparable expense to those undergoing acute fixation which suggests targeting these patients is a more cost-effective strategy.
Knee osteoarthritis is a common, debilitating condition. Intra articular corticosteroid injections are a commonly used non-operative treatment strategy. Intra articular hip injection with Ketorolac (an NSAID) has proven to be as efficacious as corticosteroids. No prior study compares the efficacy of Ketorolac relative to corticosteroids for relief of discomfort in knee osteoarthritis. The study design was a single centre double blinded RCT. Severity of osteoarthritic changes were graded on plain film weightbearing radiographs using the Kellgren and Lawrence system. Injection was with either 30mg Ketorolac or 40mg Methylprednisolone, given by intra-articular injection, in a syringe with 5mls 0.5% Marcaine. Pre-injection clinical outcomes were assessed using the Numerical Pain Score (NPS), WOMAC, and Oxford knee scores. Patients' NPS scores were assessed at Day 1 and Day 14 post-injection. An assessment of all clinical outcomes took place in clinic at six weeks. There were 72 participants (83 knees) in the study. No patients were lost to follow-up. Mean age was 62.66 years (Range 29–85). 42 knees received a corticosteroid injection, 41 a NSAID injection. Mean Kellgren and Lawrence score was 3.1. There was no significant difference in pre-injection clinical scores in either group. There was a significant improvement of NPS on Day 1 and 14 in both injection groups(p<0.05). These improved pain scores were sustained at 6 weeks in both groups. WOMAC and Oxford Knee Scores showed a statistically significant improvement in the corticosteroid group. WOMAC scores showed significant improvement in the NSAID group, however these improvements didn't achieve statistical significance using the Oxford Knee Score. Corticosteroid or NSAID injectate are a safe and effective non-operative treatment strategy in the patient with knee osteoarthritis. Ketorolac appears to provide effective medium-term improvement of pain and clinical scores. Further follow-up is recommended to investigate if this trend in sustained.
In a previously published multicenter randomized clinical trial it was shown that young patients (16–60 years-old) with displaced mid-shaft clavicle fractures had superior limb specific outcomes when they were treated with primary plate fixation versus non operative treatment at one year follow-up. This study examines the general health status of this cohort of patients at two-years post injury. We evaluated the general health of a cohort of patients with displaced mid-shaft clavicle fractures comparing non-operative versus plate fixation at two-years after injury. At the conclusion of our study, eighty-nine patients (fifty-four from the operative group and thirty-five from the non-operative group) completed the two-year follow-up. Outcome analysis included the standard clinical follow-up and SF-36 scores.Purpose
Method
A randomised clinical trial was undertaken to find out if treatment time and failure rate in children treated by the Ponseti method differed between below-knee vs above-knee cast groups. Eligible children with idiopathic clubfoot, treated using the Ponseti method, were randomised to either below knee or above knee plaster of Paris casting. Outcome measures were total treatment time and the occurrence of failure, defined as two slippages or a treatment time above eight weeks. Twenty-six children (33 feet) were entered into the trial, with a mean age of 17 days (range 1–40) in the above knee and 11 days (range 5–20) in the below knee group. Because of six failures in the below knee group (38%), the trial was stopped early for ethical reasons. Failure rate was significantly higher in the below-knee group (P 0.039). The median treatment times of six weeks in the below knee and four weeks in the above knee group differed significantly (P 0.01).Statement of purpose:
Methods and Results:
In this 2-year randomised clinical trial we examined whether cemented femoral prosthesis geometry affects the pattern of strain-adaptive bone remodelling in the proximal femur after THA. 128 patients undergoing primary THA were randomised to receive a Charnley (shape-closed, no taper), Exeter (force-closed, double-tapered) or C-stem (forced-closed, triple-tapered) prosthesis. All received a cemented Charnley cup. Proximal femoral BMD change over 2 years was measured by DXA. Urine and serum samples were collected at pre-operative baseline and over 1 year post-operatively. N-telopeptides of type-I-collagen (NTX) was measured in urine as a marker of osteoclast activity and Osteocalcin (OC) in serum as a maker of osteoblast activity. Clinical outcome using the Harris and Oxford hip scores, and prosthesis migration measured using digitised radiographs (EBRA-Digital) were measured over 2 years. The baseline characteristics of the subjects in each group were similar (P>
0.05). Decreases in femoral BMD were observed over the first year for all prosthesis designs. Bone loss was greatest (14%) in the proximal medial femur (region 7). The pattern and amount of bone loss observed was similar between all prosthesis designs (P>
0.05). Transient rises in both osteoclast (NTX) and osteoblast (OC) activity also occurred over year 1, and were similar in pattern in the 3 prosthesis groups (p>
0.05). All prostheses showed migration patterns that were true to their design type and similar improvements in clinical hip scores were observed over the 2 year study. Differences in the proposed mechanism of load transfer between prosthesis and host bone in force-closed versus shape-closed femoral prosthesis designs in THA are not major determinants of prosthesis-related remodelling.
There is a lack of properly undertaken comparative studies of total hip replacement (THR). A randomised trial was established to examine the hypothesis that there are no important differences in clinical outcome at 2 years and at long-term follow-up between cemented and uncemented primary THR in middle aged patients.Eighty-three patients with 90 osteoarthritic hips were randomised to a cemented Exeter THR involving a matte or polished tapered stem (n=47, median age 68yrs) or an uncemented PCA proximally porous-coated cobalt-chrome stem and porous coated press fit cup (n=43, median age 66yrs). Patients underwent immediate full weight bearing post-operatively. The follow-up period is 8 to 16 years. The median Harris hip scores for the cemented and uncemented groups respectively were 92 and 95 at 2 years and 89 and 96 at long-term follow-up. Four cemented hips have been revised for aseptic loosening. There have been no failures of the polished stems. An analysis of a larger series of matt versus polished cemented stems also found that the results of the polished stems were superior. Four uncemented hips have been revised, two more recently for acetabular wear and osteolysis. There was a high rate of radiographic demarcation of the cemented cups. There were no important differences in the clinical scores between cemented and uncemented THR. Some matte surfaced femoral stems failed and this trend was confirmed by analysis of a larger series. Osteolysis around the uncemented acetabular components is a concern. Importantly immediate weight bearing was associated with good results of uncemented stems.
Dislocation after revision total hip is a common complication. The purpose of this study was to assess whether a large femoral head (36/40mm) would result in a decreased dislocation rate compared to a standard head (32mm). A randomized clinical trial was undertaken to assess the effect of large femoral heads on dislocation after revision total hip. Patients undergoing revision hip arthroplasty at seven centers were randomized to 32mm head or 36/40mm head. Patients were stratified according to surgeon. Primary endpoint was dislocation. Rates were compared with Fishers exact test. Secondary outcome measures were quality of life: WOMAC, SF-36 and satisfaction. One hundred eighty four patients were randomized: 92 in the 32mm head group and 92 in the large head group. Baseline demographics were similar in the two groups. Patients were followed from two to five years postoperativelyPurpose
Method
Several recent studies have shown an increased incidence of symptomatic non-unions and malunions after non-operative treatment of displaced clavicle fractures. Our multicenter randomized control trial comparing sling treatment and plate fixation shows statistically significant improvement in patient oriented outcome measures at all time points measured over one year of follow-up. Non-operative group complications included six non-unions, one symptomatic malunion and one patient with reflex sympathetic dystrophy in thirty-four patients. Complications in the operative group included one wound dehiscence and two patients requiring plate removal in thirty-seven patients. This study supports plate fixation of acute clavicle fractures in selected cases. To compare patient oriented outcomes of non-operative and operative treatment of displaced clavicle shaft fractures. Operative fixation of displaced clavicle shaft fractures provides statistically significant improvement in functional outcome over sling treatment at one year of follow-up. This study supports operative fixation of displaced clavicle shaft fractures in selected cases. Seventy-one of one hundred and twenty patients have at least one year of follow-up. Non-operative group (N=34) consisted of twenty-four males with an average age thirty-two injuring fourteen dominant clavicles. The operative group (N= 37) consisted of thirty-three males with an average age of 34.5 years injuring twenty-one dominant clavicles. CSS and DASH scores were statistically different at all time points measured (p=0.001, p=0.021 respectively). Complications in the non-operative group included one patient with RSD, one symptomatic malunion and six patients with non-unions requiring ORIF. In the operative group, two patients experienced local plate irritation and one late wound dehiscence. Randomization was by sealed envelope. Non-operative treatment was symptomatic in a sling, while operative patients underwent ORIF. CSS, DASH and SF-36 scores were collected at six weeks, three months, six months and twelve months. Statistical analysis was completed by repeated measures multivariate analysis using SPSS. Recent studies have shown a higher incidence of symptomatic malunions and non-unions after sling treatment. Currently, sling treatment is standard of care for these fractures. Our study shows statistically signifi-cant improvement in functional outcome with operative treatment with few complications. This study supports operative treatment of displaced clavicle shaft fractures in selected cases. Funding: OTA, Zimmer Inc Please contact author for graphs and diagrams.
Electrothermal arthroscopic capsulorrhaphy (ETAC) was a technology introduced for orthopaedic surgery without good scientific clinical evidence supporting its use. This multicentre randomized clinical trial provides the scientific clinical evidence comparing ETAC to Open Inferior Capsular Shift (ICS), by measuring disease-specific quality of life at 2-years post-operatively, in patients with shoulder instability due to capsular redundancy. Fifty-four subjects (37 females and 17 males; mean age 23.3 years (SD = 6.9; 15–44 years) with multidirectional instability (MDI) or multidirectional laxity with antero-inferior instability (MDL-AII) were randomized intra-operatively to ETAC (n = 28) or Open ICS (n = 26) using concealed envelopes, computer-generated, variable block randomization with stratification by surgeon and type of instability. Outcomes were measured at baseline, 3 and 6 months, 1 and 2 years. The Western Ontario Shoulder Instability (WOSI) Index is a quality of life outcome measure that is scored on a visual analog scale from 0 to 100, where a higher score represents better quality of life. Two functional assessments included the American Shoulder and Elbow Society (ASES) Score and the Constant Score. Post-operative recurrent instability and surgical time were also measured. Analyses included ANOVA of repeated measures with Bonferroni adjustments for multiple comparisons, Chi-square and independent t-tests (p < 0.05).Purpose
Method
The purpose of this study was to determine the benefit and risk of NSAID-based prophylaxis for ectopic bone formation amongst patients undergoing total hip replacement (or revision) surgery. A double-blind randomised placebo-controlled clinical trial, stratified by treatment site and surgery (primary or revision), was conducted in 20 orthopaedic surgery centres in Australia and New Zealand. 902 patients, undergoing elective primary or revision total hip replacement surgery, were randomly allocated to 14 days treatment with ibuprofen (1200mg daily) or matching placebo commenced within 24 hours of surgery. Patients were only excluded if there was, in the opinion of the responsible physician, a definite indication or contra-indication for treatment with an NSAID during the 14 day study treatment period. Outcomes were assessed six to 12 months after surgery and included changes in self-reported hip pain and physical function (WOMAC), physical performance measures and radiographic evidence of ectopic bone formation. There was only a 6% loss to follow-up for self-report measures and a 12% loss to follow-up for radiographs. Six to twelve months after surgery, there were no significant differences between the ibuprofen and placebo groups for improvements in hip pain (mean difference, 95% confidence interval: −0.1, −0.4 to 0.2, p=0.6) or physical function (−0.1, −0.4 to 0.2, p=0.5), despite a much reduced risk of ectopic bone formation (relative risk 0.69, 95% confidence interval 0.56 to 0.83) associated with ibuprofen. There was a significantly increased risk of major bleeding complications during the admission period (2.09, 1.00 to 4.39) These data, from the largest-ever trial of prophylaxis against ectopic bone formation, do not support the use of routine NSAIDs-based prophylaxis for patients undergoing total hip replacement surgery.
The current standard of care in Calgary, Alberta for management of a ruptured Achilles tendon is surgical repair, typically performed following admission to hospital. The primary objective of this study was to compare the costs of hospital treatment and complications associated with the surgical repair of Achilles tendon ruptures between two groups of patients: Group One = patients enrolled in the randomised clinical trial (RCT) Multicentre Achilles Tendon Treatment Study (MATTS), Group Two = all other non-study patients. This observational cohort study analyzed all patients surgically treated for Achilles tendon ruptures at Calgary area hospitals over a three-year period (October 2002–September 2005). Inclusion criteria: age eighteen to seventy years, acute rupture. A total of two hundred and eighty-two patients met the inclusion criteria; thirty-three patients were included in Group One, two hundred and forty-nine patients in Group Two. In Group One, twenty-seven patients (82%) were treated as outpatients, five patients (15%) were ADOP-24hr, and one patient (3%) was admitted. In Group Two, twenty-seven patients (11%) were treated as outpatients, ninety-five patients (38%) were ADOP-24hr, and one hundred and twenty-seven patients (51%) were admitted. The total costs for patients treated as outpatients and requiring overnight stays in Group One were $18,408 and $7,419, respectively. In Group Two, the total cost for outpatients was $18,071 compared to $379,496 for non-study patients requiring overnight stay. If all overnight patients in each group were treated as outpatients, the total savings would be $235,545. There were no serious complications in Group One. In Group Two, complications included two cases of pulmonary embolus, and one case of compartment syndrome requiring readmission. All complications resolved. Surgical treatment of Achilles tendon rupture can be performed safely and at less cost on an outpatient basis. Participation in this RCT has allowed us to recommend a change in the standard of care in Calgary.
Proximal tibial bone density (BD) is a key determinant in the migration of implants following total knee arthroplasty (TKA). CT-osteodensitometry offers three-dimensional, volumetric analysis of both cortical and cancellous regions and has been shown to be both accurate and reliable about the hip. The primary objective of this study is to assess differences in the bone remodelling pattern (tibial segment) of patients operated on using fixed or rotating platform, using CT-osteodensitometry. The hypothesis is that the presence of a rotating platform optimises stress distribution along the proximal tibia, resulting in reduced proximal bone remodelling of tibia. The secondary objective is to correlate the osteodensitometry and clinical data at follow-up. Following completion of the initial assessment and after obtaining written informed consent, the patients were randomly allocated to either a PFC Sigma fixed bearing or a PFC Sigma rotating platform (mobile bearing) total knee system (DePuy, Leeds, UK). Clinical follow-ups were performed at three months, one year, and two years after the index operation. CT scans were performed immediately post-operatively and at one and two years respectively. 52 knees (47 patients) were randomised for cemented TKR management using rotating or fixed tibia platform and followed up at one and two years. At the two year follow-up, the knee function and patellar scores were comparable in both groups. There were no radiographic signs of loosening, and no revision surgery was performed. Sequential BD measurement from post-operative baseline to two year follow-up showed minimal differences between the fixed and rotating platform implants. Bone density assessment showed a 20% mean loss of cancellous BD and minimal changes of cortical BD, with little differences between the two groups. Loss of cancellous BD appears progressive. In conclusion, this study shows that the mode of fixation of the TKR polyethylene liner does not influence bone remodelling of the proximal tibia after surgery. This is the first study performed to assess separately cortical and cancellous BD changes in THR. There are no data in the literature for comparison.
We compared self-reported pain and function, complications and revision rates, and radiographic outcomes of hydroxylapatite(HA) or cemented tibial fixation in the first five years following primary total knee arthroplasty. This was a randomised clinical trial of eighty-one patients Prospective, randomised clinical trial. Patients less than seventy years of age with non-inflammatory knee arthritis. Eighty-one patients were randomised at the time of surgery to receive HA or cemented tibial fixation. Subjects were evaluated preoperatively, six months, one and five years postoperatively by a physical therapist who was blinded to group allocation. X-rays were evaluated by an experienced arthroplasty surgeon who did not perform any of the surgeries. Self-reported pain and function, the primary outcomes, were measured by the Western Ontario McMaster (WOMAC) Osteoarthritis Index and the RAND 36-item Health Services Inventory (RAND-36). Complications and revision rates were determined through hospital record review and at each patient evaluation. The Knee Society Radiological Score was used to evaluate plain radiographs at each assessment. There was slightly more pain in HA group at six months as measured by both the WOMAC and RAND-36, a difference that disappeared by the one-year assessment. There were no differences in function, radiographic findings or complications at any time. Finally, no subjects required revision of the tibial prosthesis during the study. Overall, no significant differences were seen between groups. The initial difference in self-reported pain disappeared by twelve-months postoperatively. At five-years postoperatively, there is no advantage to HA tibial fixation over cemented tibial fixation.
Arthroscopic management has been recommended for some SLAP lesions, but no studies have focused on patients over 50 with rotator cuff tear and Type II SLAP lesion. Our hypothesis was that there was no difference in clinical outcome between repairing of the Type II SLAP lesion and tenotomy of the long head of the biceps tendon after having repaired the rotator cuff tear. This was a randomized controlled clinical trial. We recruited 63 patients. In 31 patients, we repaired the rotator cuff and the Type II SLAP lesion (Group 1). In the other 32 patients, we repaired the rotator cuff and tenomized the long head of the biceps (Group 2). 7 patients (2 in the group 1 and 5 in the group 2) were lost to final follow up. At the 5.2 year follow-up, statistically significant differences were seen with respect to the UCLA score and ROM values. In Group 1 (SLAP repair and rotator cuff repair), the UCLA showed a statistically significant improvement from a pre-operative average rating of 10.4 (range 6 to 14) to an average of 27.9 (24–35) postoperatively (P<
0.001). In Group 2 (biceps tenotomy and rotator cuff repair) the UCLA showed a statistically significant improvement from a pre-operative average rating of 10.1 (range 5 to 14) to an average of 32.1 (range 30 to 35) post-operatively (P<
0.001) There was statistically significant difference in total post-operative UCLA scores and ROM when comparing the two groups post-operatively (P<
0.05). There are no advantages in repairing a Type II SLAP lesion when associated with a rotator cuff tear in patients over 50. Rotator cuff repair alone is sufficient to produce a good post-operative outcome, allowing to avoid post-operative stiffness of the shoulder.
Use of a large femoral head metal-on-metal bearing in total hip arthroplasty may offer an advantage in terms of dislocation rates and more natural joint kinematics. The acetabular component is more rigid however in these prostheses and if not placed accurately can lead to increased levels of metal ion release. A prospective randomized controlled trial was conducted to quantify bone mineral density on the acetabular side, as well as compare metal ion levels from a standard metal-on-polyethylene bearing to a large head metal-on-metal bearing in primary total hip arthroplasty. Fifty patients were randomized to receive total hip arthroplasty with either the CONSERVE A-Class Total Hip with BFH femoral head or the Lineage acetabular component with polyethylene insert and cobalt chrome femoral head. There were 27 females (11 BFH) and 23 males (14 BFH), with a mean overall age of 61.6 (range 47.7–73.2). Serum levels of cobalt, chromium, and titanium were measured at regular intervals up to two years. Harris Hip Score, WOMAC, UCLA, and RAND-36 were completed at these same intervals. Standard radiographs as well as periprosthetic BMD were performed.Purpose
Method
This study is a prospective randomised clinical trial which primary objective was to demonstrate the safety and efficacy of a single posterior mini-incision approach compared to a standard posterior approach for hemiarthroplasty in acute femoral neck fractures. Fifty-five patients have been randomised: twenty-four patients in the mini-incision surgery group (MIS) and thirty-one patients in the standard incision group (STD). The mini-incision was defined as less than 8cm. Data were collected preoperatively and at four days, three and six weeks, three, six, twelve, and twenty-four months postoperatively. The Jaglal Lower Extremity Measurement (LEM) and the Time Up and Go (TUG) where evaluated. Secondary endpoints of pain, function, and quality of life where assessed by the components of the Harris hip Score and SF-36. Radiograghic outcomes where also evaluated. The demographic data where similar between the two groups for age, gender, weight, type of anaesthesia used, pre-operative haemoglobin and preoperative comorbidities. There was no significant difference for operative time, blood losses, 72h postoperative haemoglobin and the need for transfusion therapy between the two groups. Also, there was no difference between the groups for post-operative morphine use and pain evaluation with the Visual Analog Scale. The functional assessment using the LEM, TUG, Harris Hip score and SF-36 scores did not demonstrate any statistically significant difference between mini and standard incision. This study demonstrates that the clinical and functional outcomes measured are similar between the two groups, thus limiting the potential benefits of MIS in hip fracture patients.
The presentation is based on the results of the nursing intervention program by using telephone contact to elderly patients with hip replacement after discharge.
Cemented stems have shown 90–100% survivorship when coupled with polyethylene acetabular component. This study aims to compare cemented stem behaviour in combination with large metal on metal (MOM) vs. metal on poly (MOP) bearings. 100 patients were recruited into a single centre RCT (we required 40 in each group for power .90 to confirm stem subsidence of >0.5mm at 2 years; p< 0.05). Recruits were randomized to MOP (28mm) or MOM femoral heads with CPCS cemented femoral stem. Assessments included X-rays (AP pelvis), Harris Hip Scores, blood metal ion levels and patient questionnaires (WOMAC, SF-36, satisfaction questionnaire). Evaluations were done pre-operatively and 3, 12 and 24 months post operatively; blood metal ion measures at 1 year.Introduction
Patients and Methods
This prospective, expertise-based randomized clinical trial compares arthroscopic to open shoulder stabilization by measuring the disease-specific quality of life outcome in patients with traumatic unidirectional anterior shoulder instability, and determining the incidence of recurrent instability at 2-years post-operatively. One hundred and ninety-six patients were randomly allocated to arthroscopic (n=98) or open (n=98) repair using an expertise-based approach with a surgeon specializing in one type of surgery. Randomization was performed using computer-generation, variable block sizes and concealed envelopes. Outcomes were measured at baseline, 3 and 6 months, 1 and 2 years post-operatively. These outcomes included the Western Ontario Shoulder Instability (WOSI) Index quality of life outcome and the American Shoulder and Elbow Society (ASES) functional outcome. Both outcomes were measured on a visual analog scale from 0 to 100, where a higher score represents better quality of life or function. Recurrent instability was categorized as traumatic/atraumatic, and as a subluxation/dislocation. Analyses included ANOVA of repeated measures and independent t-tests. Bonferroni adjustments for pairwise contrasts were made for multiple comparisons. Chi-squared analyses were performed on recurrence. Statistical significance was reported at p < 0.05.Purpose
Method
Bone morphogenic protein (BMP-2) is used in spinal arthrodesis to induce bone growth. Studies have demonstrated that it achieves similar fusion rates compared to iliac crest bone graft when used in instrumented fusions. Our study aims at evaluating the requirement for instrumentation in one and two-level spinal arthrodeses when BMP-2 is used in conjunction with local bone to achieve fusion. 50 patients were recruited and randomized to instrumented versus non-instrumented spinal arthrodesis. BMP-2 with local autologous bone was used in all patients. Patients are evaluated at 3-months, 6-months, 12-months, and 24-months postoperatively with questionnaires to assess clinical outcome (ODI, VAS and SF-36), and PA and lateral x-rays of the spine to assess radiographic fusion (Lenke score). At 24 months, a thin-cut (1mm) CT scan was performed.Purpose
Method
We performed a prospective, randomised, blinded clinical trial comparing metal versus polyethylene bearing surfaces in patients receiving a THA. Forty-one patients were randomised to receive a metal (twenty-three) or a polyethylene (eighteen) insert with identical femoral and acetabular components. The metal bearing was a 28mm low carbon on high carbon couple. Patients were evaluated pre-operatively, at three, six, twelve months and annually thereafter, including an evaluation of erythrocyte and urine cobalt, chromium, and titanium, outcome measures (WOMAC, SF-12, Harris Hip Score) and radiographs. No patients were lost to follow-up. At an average 7.2 (range 6.1 – 7.8) years follow-up there were no differences in any outcome measures or radiographic findings. Patients receiving metal liners had significantly elevated metal ion measurements. At most recent follow-up, compared to the polyethylene control group, patients receiving a metal on metal bearing had erythrocyte cobalt levels were eleven times elevated (median 1.4 μg/L (metal) vs 0.12 μg/L (poly), p<
.001). Urine cobalt levels were thirty-nine times elevated (median 11.4 μg/L/day (metal) vs 0.29 μg/day (poly), p<
.001) and urine chromium levels were twenty-eight times elevated (median 4.75 μg/day (metal) vs 0.17 μg/day (poly), p<
.001). Additionally the metal ion levels reached an early steady state level and did not decrease over time. (Erythrocyte Co (μg/L): 1.29 (6 mos), 1.20 (1 yr), 1.0 (2 yr), 1.10 (3 yr), 1.35 (4 yr), 1.40 (5 yr)). Both cobalt and chromium ion measurements were significantly elevated in the blood and urine of the patients randomised to receive the metal on metal THA at all time intervals. Contrary to previous reports, in 34% of patients with a metal liner, metal ion (erythrocyte cobalt) elevation was still increasing at latest follow-up, and in the overall metal on metal patient cohort, metal ion median levels were not decreasing over time. As in polyethylene wear data, metal ion results are not necessarily generalizable, but are bearing design specific.
Closure with interrupted mattress sutures is useful where careful skin apposition is required following hindfoot surgery. However, suture removal can be technically difficult and painful. Modification with an additional suture loop creates a “traction loop suture”. We hypothesise this technique makes suture removal quicker and reduced tension placed on sutures during their removal reduces pain. 37 patients undergoing elective hindfoot surgery took part in a prospective clinical trial comparing traditional interrupted sutures with traction loop sutures. Each patient underwent half of each wound sutured with both types. Sutures were removed at 2 weeks and pain levels were determined during removal using the 10 cm visual analogue pain scale. Duration of time taken for each type of suture removal was measured. Wound complications were recorded at 2 and 6 weeks post-operative. Results demonstrated traction loop sutures were 43% less painful to remove per wound than normal interrupted sutures (mean difference 1.06; standard deviation 1.56; 95% confidence interval 0.50 to 1.62; p-value 0.001). Traction loop sutures were also 31% quicker to remove per wound (mean difference 15.72 seconds; standard deviation 19.98; confidence interval 8.51 to 22.93; p-value <
0.001). At 2 weeks, 1 normally sutured wound suffered dehiscence. At 6 weeks, no complications were noted in either group. Our results demonstrate that traction loop sutures provide a quick and simple means of reducing patients’ pain and time during suture removal. Traction loop suturing technique could be applied to other surgical specialities where interrupted suture closure is indicated.
Total hip and knee arthroplasty (THA, TKA) are largely successful procedures; however, both have variable outcomes, resulting in some patients being dissatisfied with the outcome. Surgeons are turning to technologies such as robotic-assisted surgery in an attempt to improve outcomes. Robust studies are needed to find out if these innovations are really benefitting patients. The Robotic Arthroplasty Clinical and Cost Effectiveness Randomised Controlled Trials (RACER) trials are multicentre, patient-blinded randomized controlled trials. The patients have primary osteoarthritis of the hip or knee. The operation is Mako-assisted THA or TKA and the control groups have operations using conventional instruments. The primary clinical outcome is the Forgotten Joint Score at 12 months, and there is a built-in analysis of cost-effectiveness. Secondary outcomes include early pain, the alignment of the components, and medium- to long-term outcomes. This annotation outlines the need to assess these technologies and discusses the design and challenges when conducting such trials, including surgical workflows, isolating the effect of the operation, blinding, and assessing the learning curve. Finally, the future of robotic surgery is discussed, including the need to contemporaneously introduce and evaluate such technologies. Cite this article:
To assess the feasibility of a randomized controlled trial (RCT) that compares three treatments for acetabular fractures in older patients: surgical fixation, surgical fixation and hip arthroplasty (fix-and-replace), and non-surgical treatment. Patients were recruited from seven UK NHS centres and randomized to a three-arm pilot trial if aged older than 60 years and had a displaced acetabular fracture. Feasibility outcomes included patients’ willingness to participate, clinicians’ capability to recruit, and dropout rates. The primary clinical outcome measure was the EuroQol five-dimension questionnaire (EQ-5D) at six months. Secondary outcomes were Oxford Hip Score, Disability Rating Index, blood loss, and radiological and mobility assessments.Aims
Methods
To assess the cost-effectiveness of a two-layer compression bandage versus a standard wool and crepe bandage following total knee arthroplasty, using patient-level data from the Knee Replacement Bandage Study (KReBS). A cost-utility analysis was undertaken alongside KReBS, a pragmatic, two-arm, open label, parallel-group, randomized controlled trial, in terms of the cost per quality-adjusted life year (QALY). Overall, 2,330 participants scheduled for total knee arthroplasty (TKA) were randomized to either a two-layer compression bandage or a standard wool and crepe bandage. Costs were estimated over a 12-month period from the UK NHS perspective, and health outcomes were reported as QALYs based on participants’ EuroQol five-dimesion five-level questionnaire responses. Multiple imputation was used to deal with missing data and sensitivity analyses included a complete case analysis and testing of costing assumptions, with a secondary analysis exploring the inclusion of productivity losses.Aims
Methods
Arthroscopic microfracture is a conventional form of treatment for patients with osteochondritis of the talus, involving an area of < 1.5 cm2. However, some patients have persistent pain and limitation of movement in the early postoperative period. No studies have investigated the combined treatment of microfracture and shortwave treatment in these patients. The aim of this prospective single-centre, randomized, double-blind, placebo-controlled trial was to compare the outcome in patients treated with arthroscopic microfracture combined with radial extracorporeal shockwave therapy (rESWT) and arthroscopic microfracture alone, in patients with ostechondritis of the talus. Patients were randomly enrolled into two groups. At three weeks postoperatively, the rESWT group was given shockwave treatment, once every other day, for five treatments. In the control group the head of the device which delivered the treatment had no energy output. The two groups were evaluated before surgery and at six weeks and three, six and 12 months postoperatively. The primary outcome measure was the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale. Secondary outcome measures included a visual analogue scale (VAS) score for pain and the area of bone marrow oedema of the talus as identified on sagittal fat suppression sequence MRI scans.Aims
Methods
The aim of this study was to estimate the incremental use of resources, costs, and quality of life outcomes associated with surgical reconstruction compared to rehabilitation for long-standing anterior cruciate ligament (ACL) injury in the NHS, and to estimate its cost-effectiveness. A total of 316 patients were recruited and randomly assigned to either surgical reconstruction or rehabilitation (physiotherapy but with subsequent reconstruction permitted if instability persisted after treatment). Healthcare resource use and health-related quality of life data (EuroQol five-dimension five-level health questionnaire) were collected in the trial at six, 12, and 18 months using self-reported questionnaires and medical records. Using intention-to-treat analysis, differences in costs, and quality-adjusted life years (QALYs) between treatment arms were estimated adjusting for baseline differences and following multiple imputation of missing data. The incremental cost-effectiveness ratio (ICER) was estimated as the difference in costs divided by the difference in QALYs between reconstruction and rehabilitation.Aims
Methods
To determine whether platelet-rich plasma (PRP) injection improves outcomes two years after acute Achilles tendon rupture. A randomized multicentre two-arm parallel-group, participant- and assessor-blinded superiority trial was undertaken. Recruitment commenced on 28 July 2015 and two-year follow-up was completed in 21 October 2019. Participants were 230 adults aged 18 years and over, with acute Achilles tendon rupture managed with non-surgical treatment from 19 UK hospitals. Exclusions were insertion or musculotendinous junction injuries, major leg injury or deformity, diabetes, platelet or haematological disorder, medication with systemic corticosteroids, anticoagulation therapy treatment, and other contraindicating conditions. Participants were randomized via a central online system 1:1 to PRP or placebo injection. The main outcome measure was Achilles Tendon Rupture Score (ATRS) at two years via postal questionnaire. Other outcomes were pain, recovery goal attainment, and quality of life. Analysis was by intention-to-treat.Aims
Methods
To estimate the potential cost-effectiveness of adalimumab compared with standard care alone for the treatment of early-stage Dupuytren’s disease (DD) and the value of further research from an NHS perspective. We used data from the Repurposing anti-TNF for Dupuytren’s disease (RIDD) randomized controlled trial of intranodular adalimumab injections in patients with early-stage progressive DD. RIDD found that intranodular adalimumab injections reduced nodule hardness and size in patients with early-stage DD, indicating the potential to control disease progression. A within-trial cost-utility analysis compared four adalimumab injections with no further treatment against standard care alone, taking a 12-month time horizon and using prospective data on EuroQol five-dimension five-level questionnaire (EQ-5D-5L) and resource use from the RIDD trial. We also developed a patient-level simulation model similar to a Markov model to extrapolate trial outcomes over a lifetime using data from the RIDD trial and a literature review. This also evaluated repeated courses of adalimumab each time the nodule reactivated (every three years) in patients who initially responded.Aims
Methods
The primary objective of this study was to compare the five-year tibial component migration and wear between highly crosslinked polyethylene (HXLPE) inserts and conventional polyethylene (PE) inserts of the uncemented Triathlon fixed insert cruciate-retaining total knee arthroplasty (TKA). Secondary objectives included clinical outcomes and patient-reported outcome measures (PROMs). A double-blinded, randomized study was conducted including 96 TKAs. Tibial component migration and insert wear were measured with radiostereometric analysis (RSA) at three, six, 12, 24, and 60 months postoperatively. PROMS were collected preoperatively and at all follow-up timepoints.Aims
Methods
Achieving accurate implant positioning and restoring native hip biomechanics are key surgeon-controlled technical objectives in total hip arthroplasty (THA). The primary objective of this study was to compare the reproducibility of the planned preoperative centre of hip rotation (COR) in patients undergoing robotic arm-assisted THA versus conventional THA. This prospective randomized controlled trial (RCT) included 60 patients with symptomatic hip osteoarthritis undergoing conventional THA (CO THA) versus robotic arm-assisted THA (RO THA). Patients in both arms underwent pre- and postoperative CT scans, and a patient-specific plan was created using the robotic software. The COR, combined offset, acetabular orientation, and leg length discrepancy were measured on the pre- and postoperative CT scanogram at six weeks following surgery.Aims
Methods
Fractures of the humeral shaft represent 3% to 5% of all fractures. The most common treatment for isolated humeral diaphysis fractures in the UK is non-operative using functional bracing, which carries a low risk of complications, but is associated with a longer healing time and a greater risk of nonunion than surgery. There is an increasing trend to surgical treatment, which may lead to quicker functional recovery and lower rates of fracture nonunion than functional bracing. However, surgery carries inherent risk, including infection, bleeding, and nerve damage. The aim of this trial is to evaluate the clinical and cost-effectiveness of functional bracing compared to surgical fixation for the treatment of humeral shaft fractures. The HUmeral SHaft (HUSH) fracture study is a multicentre, prospective randomized superiority trial of surgical versus non-surgical interventions for humeral shaft fractures in adult patients. Participants will be randomized to receive either functional bracing or surgery. With 334 participants, the trial will have 90% power to detect a clinically important difference for the Disabilities of the Arm, Shoulder and Hand questionnaire score, assuming 20% loss to follow-up. Secondary outcomes will include function, pain, quality of life, complications, cost-effectiveness, time off work, and ability to drive.Aims
Methods
Isolated fractures of the ulnar diaphysis are uncommon, occurring at a rate of 0.02 to 0.04 per 1,000 cases. Despite their infrequency, these fractures commonly give rise to complications, such as nonunion, limited forearm pronation and supination, restricted elbow range of motion, radioulnar synostosis, and prolonged pain. Treatment options for this injury remain a topic of debate, with limited research available and no consensus on the optimal approach. Therefore, this trial aims to compare clinical, radiological, and functional outcomes of two treatment methods: open reduction and internal fixation (ORIF) versus nonoperative treatment in patients with isolated ulnar diaphyseal fractures. This will be a multicentre, open-label, parallel randomized clinical trial (under National Clinical Trial number NCT01123447), accompanied by a parallel prospective cohort group for patients who meet the inclusion criteria, but decline randomization. Eligible patients will be randomized to one of the two treatment groups: 1) nonoperative treatment with closed reduction and below-elbow casting; or 2) surgical treatment with ORIF utilizing a limited contact dynamic compression plate and screw construct. The primary outcome measured will be the Disabilities of the Arm, Shoulder and Hand questionnaire score at 12 months post-injury. Additionally, functional outcomes will be assessed using the 36-Item Short Form Health Survey and pain visual analogue scale, allowing for a comparison of outcomes between groups. Secondary outcome measures will encompass clinical outcomes such as range of motion and grip strength, radiological parameters including time to union, as well as economic outcomes assessed from enrolment to 12 months post-injury.Aims
Methods
public hospital-based secondary care versus private community-based primary care in Ireland.
The purpose of the current study was to compare mid-term outcomes of posterior cruciate retaining(CR) versus posterior cruciate substituting (PS)procedures, using the Genesis II total knee arthroplasty (TKA) system(Smith and Nephew, Memphis TN). Ninety nine CR and 93 PS TKA’s were analysed in this prospective, randomised, clinical trial. Surgeries were performed at seven medical centres by participating surgeons. Clinical outcomes (Knee Society Score, Range of Motion, WOMAC, SF 12 : and radiographic findings), in addition to postoperative complications, were evaluated with a minimum follow-up of five years. Following data analysis, there were no Significant differences in patient demographics or pre-operative clinical measures between the two groups. At the latest follow-up interval, no Significant differences were found between the CR and PS groups with regard to functional assessment, patient satisfaction or post-operative complications. However the PS group did display statistically Significant improvements in range of motion when compared with the CR group. The results of this investigation would suggest that while comparable in regards to supporting good clinical outcomes, the PS Genesis II design does appear to support significantly improved post-operative range of motion when compared with the CR design
The aim of this study was to compare the clinical outcomes of robotic arm-assisted bi-unicompartmental knee arthroplasty (bi-UKA) with conventional mechanically aligned total knee arthroplasty (TKA) during the first six weeks and at one year postoperatively. A per protocol analysis of 76 patients, 43 of whom underwent TKA and 34 of whom underwent bi-UKA, was performed from a prospective, single-centre, randomized controlled trial. Diaries kept by the patients recorded pain, function, and the use of analgesics daily throughout the first week and weekly between the second and sixth weeks. Patient-reported outcome measures (PROMs) were compared preoperatively, and at three months and one year postoperatively. Data were also compared longitudinally and a subgroup analysis was conducted, stratified by preoperative PROM status.Aims
Methods
To report early (two-year) postoperative findings from a randomized controlled trial (RCT) investigating disease-specific quality of life (QOL), clinical, patient-reported, and radiological outcomes in patients undergoing a total shoulder arthroplasty (TSA) with a second-generation uncemented trabecular metal (TM) glenoid versus a cemented polyethylene glenoid (POLY) component. Five fellowship-trained surgeons from three centres participated. Patients aged between 18 and 79 years with a primary diagnosis of glenohumeral osteoarthritis were screened for eligibility. Patients were randomized intraoperatively to either a TM or POLY glenoid component. Study intervals were: baseline, six weeks, six-, 12-, and 24 months postoperatively. The primary outcome was the Western Ontario Osteoarthritis Shoulder QOL score. Radiological images were reviewed for metal debris. Mixed effects repeated measures analysis of variance for within and between group comparisons were performed.Aims
Methods
This study sought to compare the rate of deep surgical site infection (SSI), as measured by the Centers for Disease Control and Prevention (CDC) definition, after surgery for a fracture of the hip between patients treated with standard dressings and those treated with incisional negative pressure wound therapy (iNPWT). Secondary objectives included determining the rate of recruitment and willingness to participate in the trial. The study was a two-arm multicentre randomized controlled feasibility trial that was embedded in the World Hip Trauma Evaluation cohort study. Any patient aged > 65 years having surgery for hip fracture at five recruitment centres in the UK was considered to be eligible. They were randomly allocated to have either a standard dressing or iNPWT after closure of the wound. The primary outcome measure was deep SSI at 30 and 90 days, diagnosed according to the CDC criteria. Secondary outcomes were: rate of recruitment; further surgery within 120 days; health-related quality of life (HRQoL) using the EuroQol five-level five-dimension questionnaire (EQ-5D-5L); and related complications within 120 days as well as mobility and residential status at this time.Aims
Methods
A pilon fracture is a severe ankle joint injury caused by high-energy trauma, typically affecting men of working age. Although relatively uncommon (5% to 7% of all tibial fractures), this injury causes among the worst functional and health outcomes of any skeletal injury, with a high risk of serious complications and long-term disability, and with devastating consequences on patients’ quality of life and financial prospects. Robust evidence to guide treatment is currently lacking. This study aims to evaluate the clinical and cost-effectiveness of two surgical interventions that are most commonly used to treat pilon fractures. A randomized controlled trial (RCT) of 334 adult patients diagnosed with a closed type C pilon fracture will be conducted. Internal locking plate fixation will be compared with external frame fixation. The primary outcome and endpoint will be the Disability Rating Index (a patient self-reported assessment of physical disability) at 12 months. This will also be measured at baseline, three, six, and 24 months after randomization. Secondary outcomes include the Olerud and Molander Ankle Score (OMAS), the five-level EuroQol five-dimenison score (EQ-5D-5L), complications (including bone healing), resource use, work impact, and patient treatment preference. The acceptability of the treatments and study design to patients and health care professionals will be explored through qualitative methods.Aims
Methods
For many designs of total knee arthroplasty (TKA) it remains unclear whether cemented or uncemented fixation provides optimal long-term survival. The main limitation in most studies is a retrospective or non-comparative study design. The same is true for comparative trials looking only at the survival rate as extensive sample sizes are needed to detect true differences in fixation and durability. Studies using radiostereometric analysis (RSA) techniques have shown to be highly predictive in detecting late occurring aseptic loosening at an early stage. To investigate the difference in predicted long-term survival between cemented, uncemented, and hybrid fixation of TKA, we performed a randomized controlled trial using RSA. A total of 105 patients were randomized into three groups (cemented, uncemented, and hybrid fixation of the ACS Mobile Bearing (ACS MB) knee system, implantcast). RSA examinations were performed on the first day after surgery and at scheduled follow-up visits at three months, six months, one year, and two years postoperatively. Patient-reported outcome measures (PROMs) were obtained preoperatively and after two years follow-up. Patients and follow-up investigators were blinded for the result of randomization.Aims
Methods
The aim of this study was to systematically compare the safety and accuracy of robot-assisted (RA) technique with conventional freehand with/without fluoroscopy-assisted (CT) pedicle screw insertion for spine disease. A systematic search was performed on PubMed, EMBASE, the Cochrane Library, MEDLINE, China National Knowledge Infrastructure (CNKI), and WANFANG for randomized controlled trials (RCTs) that investigated the safety and accuracy of RA compared with conventional freehand with/without fluoroscopy-assisted pedicle screw insertion for spine disease from 2012 to 2019. This meta-analysis used Mantel-Haenszel or inverse variance method with mixed-effects model for heterogeneity, calculating the odds ratio (OR), mean difference (MD), standardized mean difference (SMD), and 95% confidence intervals (CIs). The results of heterogeneity, subgroup analysis, and risk of bias were analyzed.Aims
Methods
Meniscal allograft transplantation is undertaken to improve pain
and function in patients with a symptomatic meniscal deficient knee
compartment. While case series have shown improvements in patient
reported outcome measures (PROMs), its efficacy has not been rigorously
evaluated. This study aimed to compare PROMs in patients having
meniscal transplantation with those having personalized physiotherapy
at 12 months. A single-centre assessor-blinded, comprehensive cohort study,
incorporating a pilot randomized controlled trial (RCT) was performed
on patients with a symptomatic compartment of the knee in which
a (sub)total meniscectomy had previously been performed. They were
randomized to be treated either with a meniscal allograft transplantation
or personalized physiotherapy, and stratified for malalignment of
the limb. They entered the preference groups if they were not willing
to be randomized. The Knee injury and Osteoarthritis Outcome Score (KOOS),
International Knee Documentation Committee (IKDC) score and Lysholm
score and complications were collected at baseline and at four,
eight and 12 months following the interventions.Aims
Patients and Methods
The aim of this study was to explore whether time to surgery affects functional outcome in displaced proximal humeral fractures A total of 250 patients presenting within three weeks of sustaining a displaced proximal humeral fracture involving the surgical neck were recruited at 32 acute NHS hospitals in the United Kingdom between September 2008 and April 2011. Of the 125 participants, 109 received surgery (fracture fixation or humeral head replacement) as per randomization. Data were included for 101 and 67 participants at six-month and five-year follow-up, respectively. Oxford Shoulder Scores (OSS) collected at six, 12, and 24 months and at three, four, and five years following randomization was plotted against time to surgery. Long-term recovery was explored by plotting six-month scores against five-year scores and agreement was illustrated with a Bland-Altman plot.Aims
Methods
The aim of this study was to examine trends in the management of fractures of the distal radius in Ireland over a ten-year period, and to determine if there were any changes in response to the English Distal Radius Acute Fracture Fixation Trial (DRAFFT). Data was grouped into annual intervals from 2008 to 2017. All adult inpatient episodes that involved emergency surgery for fractures of the distal radius were includedAims
Patients and Methods
The Ankle Injury Management (AIM) trial was a pragmatic equivalence randomized controlled trial conducted at 24 hospitals in the United Kingdom that recruited 620 patients aged more than 60 years with an unstable ankle fracture. The trial compared the usual care pathway of early management with open reduction and internal fixation with initially attempting non-surgical management using close contact casting (CCC). CCC is a minimally padded cast applied by an orthopaedic surgeon after closed reduction in the operating theatre. The intervention groups had equivalent functional outcomes at six months and longer-term follow-up. However, potential barriers to using CCC as an initial form of treatment for these patients have been identified. In this report, the results of the AIM trial are summarized and the key issues are discussed in order to further the debate about the role of CCC. Evidence from the AIM trial supports surgeons considering conservative management by CCC as a treatment option for these patients. The longer-term follow-up emphasized that patients treated with CCC need careful monitoring in the weeks after its application to monitor maintenance of reduction. Cite this article:
The aim of this study was to compare the clinical effectiveness of Kirschner wire (K-wire) fixation with locking-plate fixation for patients with a dorsally displaced fracture of the distal radius in the five years after injury. We report the five-year follow-up of a multicentre, two-arm, parallel-group randomized controlled trial. A total of 461 adults with a dorsally displaced fracture of the distal radius within 3 cm of the radiocarpal joint that required surgical fixation were recruited from 18 trauma centres in the United Kingdom. Patients were excluded if the surface of the wrist joint was so badly displaced it required open reduction. In all, 448 patients were randomized to receive either K-wire fixation or locking-plate fixation. In the K-wire group, there were 179 female and 38 male patients with a mean age of 59.1 years (19 to 89). In the locking-plate group, there were 194 female and 37 male patients with a mean age of 58.3 years (20 to 89). The primary outcome measure was the patient-rated wrist evaluation (PRWE). Secondary outcomes were health-related quality of life using the EuroQol five-dimension three-level (EQ-5D-3L) assessment, and further surgery related to the index fracture.Aims
Patients and Methods
The aim of this study was to determine the stability of a new
short femoral stem compared with a conventional femoral stem in
patients undergoing cementless total hip arthroplasty (THA), in
a prospective randomized controlled trial using radiostereometric
analysis (RSA). A total of 53 patients were randomized to receive cementless
THA with either a short femoral stem (MiniHip, 26 patients, mean
age: 52 years, nine male) or a conventional length femoral stem
(MetaFix, 23 patients, mean age: 53 years, 11 male). All patients
received the same cementless acetabular component. Two-year follow-up
was available on 38 patients. Stability was assessed through migration
and dynamically inducible micromotion. Radiographs for RSA were
taken postoperatively and at three, six, 12, 18, and 24 months.Aims
Patients and Methods
The aim of this study was to identify the most effective regimen
of multiple doses of oral tranexamic acid (TXA) in achieving maximum
reduction of blood loss in total knee arthroplasty (TKA). In this randomized controlled trial, 200 patients were randomized
to receive a single dose of 2.0 g of TXA orally two hours preoperatively
(group A), a single dose of TXA followed by 1.0 g orally three hours
postoperatively (group B), a single dose of TXA followed by 1.0 g
three and nine hours postoperatively (group C), or a single dose
of TXA followed by 1.0 g orally three, nine, and 15 hours postoperatively
(group D). All patients followed a routine enhanced-recovery protocol.
The primary outcome measure was the total blood loss. Secondary
outcome measures were hidden blood loss (HBL), reduction in the
level of haemoglobin, the rate of transfusion and adverse events.Aims
Patients and Methods
The aim of this study was to compare the cost-effectiveness of
intramedullary nail fixation and ‘locking’ plate fixation in the
treatment of extra-articular fractures of the distal tibia. An economic evaluation was conducted from the perspective of
the United Kingdom National Health Service (NHS) and personal social
services (PSS), based on evidence from the Fixation of Distal Tibia
Fractures (UK FixDT) multicentre parallel trial. Data from 321 patients
were available for analysis. Costs were collected prospectively
over the 12-month follow-up period using trial case report forms
and participant-completed questionnaires. Cost-effectiveness was
reported in terms of incremental cost per quality adjusted life
year (QALY) gained, and net monetary benefit. Sensitivity analyses
were conducted to test the robustness of cost-effectiveness estimates.Aim
Patients and Methods
This study aimed to compare the change in health-related quality
of life of patients receiving a traditional cemented monoblock Thompson
hemiarthroplasty compared with a modern cemented modular polished-taper
stemmed hemiarthroplasty for displaced intracapsular hip fractures. This was a pragmatic, multicentre, multisurgeon, two-arm, parallel
group, randomized standard-of-care controlled trial. It was embedded
within the WHiTE Comprehensive Cohort Study. The sample size was
964 patients. The setting was five National Health Service Trauma
Hospitals in England. A total of 964 patients over 60 years of age who
required hemiarthroplasty of the hip between February 2015 and March
2016 were included. A standardized measure of health outcome, the
EuroQol (EQ-5D-5L) questionnaire, was carried out on admission and
at four months following the operation.Aims
Patients and Methods
Aims. Treatment of Weber B ankle fractures that are stable on weightbearing radiographs but unstable on concomitant stress tests (classified SER4a) is controversial. Recent studies indicate that these fractures should be treated nonoperatively, but no studies have compared alternative nonoperative options. This study aims to evaluate patient-reported outcomes and the safety of fracture treatment using functional orthosis versus cast immobilization. Methods. A total of 110 patients with Weber B/SER4a ankle fractures will be randomized (1:1 ratio) to receive six weeks of functional orthosis treatment or cast immobilization with a two-year follow-up. The primary outcome is patient-reported ankle function and symptoms measured by the Manchester-Oxford Foot and Ankle Questionnaire (MOxFQ); secondary outcomes include Olerud-Molander Ankle Score, radiological evaluation of ankle congruence in weightbearing and gravity stress tests, and rates of treatment-related adverse events. The Regional Committee for Medical and Health Research (approval number 277693) has granted ethical approval, and the study is funded by South-Eastern Norway Regional Health Authority (grant number 2023014). Discussion.
Background. It has become increasingly important to conduct studies assessing clinical outcomes, reoperation rates, and revision rates to better define the indications and efficacy of lumbar spinal procedures and its association with symptomatic adjacent segment degeneration (sASD). Adjacent segment degeneration (ASD) is defined as the radiographic change in the intervertebral discs adjacent to the surgically treated spinal level. SASD represents adjacent segment degeneration which causes pain or numbness due to post-operative spinal instability or nerve compression at the same level. The most common reason for early reoperation and late operation is sASD, therefore is in our best interest to understand the causes of ASD and make steps to limit the occurrence. Method. A comprehensive literature search was performed selecting
Aims. Intra-articular (IA) injection may be used when treating hip osteoarthritis (OA). Common injections include steroids, hyaluronic acid (HA), local anaesthetic, and platelet-rich plasma (PRP). Network meta-analysis allows for comparisons between two or more treatment groups and uses direct and indirect comparisons between interventions. This network meta-analysis aims to compare the efficacy of various IA injections used in the management of hip OA with a follow-up of up to six months. Methods. This systematic review and network meta-analysis used a Bayesian random-effects model to evaluate the direct and indirect comparisons among all treatment options. PubMed, Web of Science, Clinicaltrial.gov, EMBASE, MEDLINE, and the Cochrane Library were searched from inception to February 2023.
There remains much debate regarding the optimal method for surgical management of patients with long head of biceps pathology. The aim of this study was to compare the outcomes of tenotomy versus tenodesis. This systematic review and meta-analysis was registered on PROSPERO (ref: CRD42020198658). Electronic databases searched included EMBASE, Medline, PsycINFO, and Cochrane Library.
To compare the efficacy of intra-articular and intravenous modes of administration of tranexamic acid in primary total knee arthroplasty in terms of blood loss and fall in haemoglobin level. Study Design:
During total knee arthroplasty (TKA), a tourniquet is often used intraoperatively. There are proposed benefits of tourniquet use including shorter duration of surgery, improved surgical field visualization and increased cement penetration which may improve implant longevity. However, there are also cited side effects that include increased post-operative pain, slowed recovery, skin bruising, neurovascular injury and quadriceps weakness.
Introduction and Objective. There remains much debate regarding the optimal method for surgical management of patients with long head of biceps pathology. The aim of this study was to compare the outcomes of tenotomy versus tenodesis. Materials and Methods. This systematic review and meta-analysis was registered on PROSPERO (ref: CRD42020198658). Electronic databases searched included EMBASE, Medline, PsycINFO, and Cochrane Library.
The application of robotics in the operating theatre for knee arthroplasty remains controversial. As with all new technology, the introduction of new systems might be associated with a learning curve. However, guidelines on how to assess the introduction of robotics in the operating theatre are lacking. This systematic review aims to evaluate the current evidence on the learning curve of robot-assisted knee arthroplasty. An extensive literature search of PubMed, Medline, Embase, Web of Science, and Cochrane Library was conducted.
Background. Routine imaging (radiography, CT, MRI) provides no health benefits for low back pain (LBP) patients and is not recommended in clinical practice guidelines. Whether imaging leads to increased costs, healthcare utilization or absence from work is unclear. Purpose. To systematically review if imaging in patients with LBP increases costs, leads to higher health care utilization or increases absence from work. METHODS.
Background. Chronic pain is a complex condition that demonstrates better outcomes in multidisciplinary rehabilitation, typically delivered to groups of patients by tertiary healthcare teams. An inter-disciplinary pain management course for individual patients was developed to increase the scope of physical therapists working in primary care by integrating osteopathic manual therapy with psychological interventions from Acceptance and Commitment Therapy (ACT), a form of ‘3rd wave’ Cognitive Behaviour Therapy. Method and Results. A single cohort study with pre-course (n=180) and post-course (n=79) self-report measures (44% response rate) evaluated six week interventions which combined individual manual therapy with self-management, delivered by teams of qualified and student osteopaths. Data included: quality of life (European Quality of Life Questionnaire); pain, mood and coping (Bournemouth Questionnaire); psychological flexibility (Revised Acceptance and Action Questionnaire); and mindfulness (Freiburg Mindfulness Inventory). Participants were predominantly female (68%), unemployed (59%), with an average age of 49 and pain duration of more than 12 months (86%). Commonly reported symptoms were low back pain (82%), neck pain (60%) and multiple sites (86%). At six months, there were statistically significant improvements in all four outcome measures (p<0.0005), with promising effect sizes in quality of life and pain coping (r=0.52) which appeared to be mediated by changes in psychological flexibility. Conclusions. This innovative, integrated, patient-centred chronic pain management course demonstrated promising outcomes when delivered by osteopaths with varying experience.
CT-based three-dimensional (3D) pre-operative imaging along with 2D orthogonal sections defined by the plane of the scapula (axial, sagittal and coronal planes) has been demonstrated by many research groups to be a very accurate way to define the bone pathology and alignment/subluxation of the humeral head in relationship to the center line of the scapula or the center of the glenoid fossa. When 3D CT imaging is combined with 3D implant templating the surgeon is best able to define the optimal implant and its location for the desired correction of the bone abnormalities. The use and value of 3D imaging is best when the there is more severe bone pathology and deformity. Transferring the computer-based information of implant location to the surgical site can involve multiple methods. The three methods discussed in the literature to date including use of standard instrumentation in a manner specified by the pre-operative planning, use of single-use patient specific instrumentation and use of reusable patient specific instrumentation. Several cadaver and sawbone studies have demonstrated significant improvement in placement of the glenoid implant with both single use and reusable patient specific instrumentation when compared to use of 2D imaging and standard instrumentation.
Chronic osteomyelitis (COM) of the lower limb in adults can be surgically managed by either limb reconstruction or amputation. This scoping review aims to map the outcomes used in studies surgically managing COM in order to aid future development of a core outcome set. A total of 11 databases were searched. A subset of studies published between 1 October 2020 and 1 January 2011 from a larger review mapping research on limb reconstruction and limb amputation for the management of lower limb COM were eligible. All outcomes were extracted and recorded verbatim. Outcomes were grouped and categorized as per the revised Williamson and Clarke taxonomy.Aims
Methods
Perthes' disease (PD) is a relatively rare syndrome of idiopathic osteonecrosis of the proximal femoral epiphysis. Treatment for Perthes' disease is controversial due to the many options available, with no clear superiority of one treatment over another. Despite having few evidence-based approaches, many patients with Perthes' disease are managed surgically. Positive outcome reporting, defined as reporting a study variable producing statistically significant positive (beneficial) results, is a phenomenon that can be considered a proxy for the strength of science. This study aims to conduct a systematic literature review with the hypothesis that positive outcome reporting is frequent in studies on the treatment of Perthes' disease. We conducted a systematic review of all available abstracts associated with manuscripts in English or with English translation between January 2000 and December 2021, dealing with the treatment of Perthes' disease. Data collection included various study characteristics, surgical versus non-surgical management, treatment modality, mean follow-up time, analysis methods, and clinical recommendations.Aims
Methods
Tourniquet use in total knee arthroplasty is convenient for the surgeon and provides a bloodless field for expeditious surgery and a dry field for cementation, but can best be described as an orthopaedic tradition. It is logical for complex anatomy of ligament, nerve, and vessel surgery but it may not be necessary for total knee replacement. In one recent randomised trial, the absence of the tourniquet was not found to affect the quality of cement fixation. There are numerous potential downsides to the use of a tourniquet including decrease range of motion, delayed recovery, increased pain, wound complications, micro-emboli, neuropathy, and increased VTE. There are also a number of complications associated with the use of a tourniquet including arterial thrombosis, skin irritation below the tourniquet, post-operative hyperemia, blood loss, less accurate intra-operative assessment, and it complicates intravenous drug administration. Studies of range of motion have shown that when there is a difference noted, the range of motion is consistently better without tourniquet use. When a tourniquet is utilised it has been found to be advantageous to only use of tourniquet for a minimal amount of the case, typically when cementing is performed. Functional strength has also been found to be improved without the use of a tourniquet. This was attributed to muscle damage, tourniquet-induced ischemia, and compressive injury. Increased peri-operative pain has also been reported in randomised trials associated with the use of a tourniquet. Edema, swelling, and limb girth issues have also been noted to be associated with tourniquet use. Exsanguinating a limb will result in swelling approximately 10% of the original volume half due to a return of blood, and half due to reactive hyperemia. Longer tourniquet times are also associated with increased wound drainage and more wound hypoxia. Tourniquet use has also been associated with embolic phenomenon with several times greater risk of large emboli associated with tourniquet use. A number of complications have been associated with tourniquet use including thromboembolic complications. In one study where quantitative MRI was utilised on both thighs after unilateral total knee replacement with and without a tourniquet, the tourniquet group showed more atrophy with a loss of 20% of the volume compared to the normal side in total knees performed with a tourniquet which also performed clinically worse. There is a small but substantial risk of arterial thrombosis particularly in patients that have atherosclerotic plaque. Ironically there is a risk of increased post-operative blood loss due to the post-tourniquet “blush” as the blood pressure and pain increase hours after a surgical procedure is completed. There is also difficulty in identifying and coagulating posterior and lateral geniculate vessels with the components in place. Utilizing a tourniquet also interferes with intra-operative assessment of patella tracking, range of motion, ligament stability, and gap balancing.
The presentations to be discussed by the panel are: 1.) No Increased Risk of Knee Arthroplasty Failure in Metal Hypersensitive Patients: A Matched Cohort Study; 2.) Knee Arthrodesis is Most Likely to Control Infection and Preserve Function Following Failed 2 Stage Procedure for Treatment of Infected TKA: A Decision Tree Analysis; 3.) Does Malnutrition Correlate with Septic Failure of Hip and Knee Arthroplasties?; 4.) Diagnosing Periprosthetic Joint Infection: The Era of the Biomarker Has Arrived; 5.) Are Patient Reported Allergies a Risk Factor for Poor Outcomes in Total Hip and Knee Arthroplasty?; 6.) Revising an HTO or UKA to TKA: Is it more like a Primary TKA or a Revision TKA?; 7.) At 5 Years Highly-Porous-Metal Tibial Components Were Durable and Reliable: A
Background.
Tourniquet use in total knee arthroplasty (TKA) is convenient for the surgeon and provides a bloodless field for expeditious surgery and a dry field for cementation, but can best be described as an orthopaedic tradition. It is logical for complex anatomy of ligament, nerve, and vessel surgery but it may not be necessary for TKA. In one recent randomised trial, the absence of the tourniquet was not found to affect the quality of cement fixation. There are numerous potential downsides to the use of a tourniquet including decrease range of motion, delayed recovery, increased pain, wound complications, micro-emboli, neuropathy, and increased VTE. There are also a number of complications associated with the use of a tourniquet including arterial thrombosis, skin irritation below the tourniquet, post-operative hyperemia, blood loss, less accurate intra-operative assessment, and it complicates intravenous drug administration. Studies of range of motion have shown that when there is a difference noted, the range of motion is consistently better without tourniquet use. When a tourniquet is utilised it has been found to be advantageous to only use the tourniquet for a minimal amount of the case, typically when cementing is performed. Functional strength has also been found to be improved without the use of a tourniquet. In a recent randomised trial, tourniquet use was associated with decreased quad strength at 3 weeks that persisted at 3 months. This was attributed to muscle damage, tourniquet-induced ischemia, and compressive injury. Increased peri-operative pain has also been reported in randomised trials associated with the use of a tourniquet. Edema, swelling, and limb girth issues have also been noted to be associated with tourniquet use. Exsanguinating a limb will result in swelling approximately 10% of the original volume half due to a return of blood, and half due to reactive hyperemia. Longer tourniquet times are also associated with increased wound drainage and more wound hypoxia as measured by transcutaneous oxygen levels. Tourniquet use has also been associated with embolic phenomenon with several times greater risk of large emboli. In one study where quantitative MRI was utilised on both thighs after unilateral total knee replacement with and without a tourniquet, the tourniquet group showed more atrophy with a loss of 20% of the volume compared to the normal side in total knees performed with a tourniquet which also performed clinically worse. There is a small but substantial risk of arterial thrombosis particularly in patients that have atherosclerotic plaque. Ironically there is a risk of increased post-operative blood loss due to the post-tourniquet “blush” as the blood pressure and pain increase hours after a surgical procedure is completed. There is also difficulty in identifying and coagulating posterior and lateral geniculate vessels with the components in place. Utilizing a tourniquet also interferes with intra-operative assessment of patella tracking, range of motion, ligament stability, and gap balancing.
Background. Despite the excellent clinical success of total knee arthroplasty (TAK), controversy remains concerning whether or not to resurface the patella. This has led to a number of randomized controlled trials.
Patients with A1 and A2 trochanteric hip fractures represent a substantial proportion of trauma caseload, and national guidelines recommend that sliding hip screws (SHS) should be used for these injuries. Despite this, intramedullary nails (IMNs) are routinely implanted in many hospitals, at extra cost and with unproven patient outcome benefit. We have used data from the National Hip Fracture Database (NHFD) to examine the use of SHS and IMN for A1 and A2 hip fractures at a national level, and to define the cost implications of management decisions that run counter to national guidelines. We used the NHFD to identify all operations for fixation of trochanteric fractures in England and Wales between 1 January 2021 and 31 December 2021. A uniform price band from each of three hip fracture implant manufacturers was used to set cost implications alongside variation in implant use.Aims
Methods
Musculoskeletal diseases are having a growing impact worldwide. It is therefore crucial to have an evidence base to most effectively and efficiently implement future health services across different healthcare systems. International trials are an opportunity to address these challenges and have many potential benefits. They are, however, complex to set up and deliver, which may impact on the efficient and timely delivery of a project. There are a number of models of how international trials are currently being delivered across a range of orthopaedic patient populations, which are discussed here. The examples given highlight that the key to overcoming these challenges is the development of trusted and equal partnerships with collaborators in each country. International trials have the potential to address a global burden of disease, and in turn optimize the benefit to patients in the collaborating countries and those with similar health services and care systems. Cite this article:
Osteoporosis is common in total hip arthroplasty (THA) patients. It plays a substantial factor in the surgery’s outcome, and previous studies have revealed that pharmacological treatment for osteoporosis influences implant survival rate. The purpose of this study was to examine the prevalence of and treatment rates for osteoporosis prior to THA, and to explore differences in osteoporosis-related biomarkers between patients treated and untreated for osteoporosis. This single-centre retrospective study included 398 hip joints of patients who underwent THA. Using medical records, we examined preoperative bone mineral density measures of the hip and lumbar spine using dual energy X-ray absorptiometry (DXA) scans and the medications used to treat osteoporosis at the time of admission. We also assessed the following osteoporosis-related biomarkers: tartrate-resistant acid phosphatase 5b (TRACP-5b); total procollagen type 1 amino-terminal propeptide (total P1NP); intact parathyroid hormone; and homocysteine.Aims
Methods
The December 2022 Hip & Pelvis Roundup360 looks at: Fix and replace: simultaneous fracture fixation and hip arthroplasty for acetabular fractures in older patients; Is the revision rate for femoral neck fracture lower for total hip arthroplasty than for hemiarthroplasty?; Femoral periprosthetic fractures: data from the COMPOSE cohort study; Dual-mobility cups and fracture of the femur; What’s the deal with outcomes for hip and knee arthroplasty outcomes internationally?; Osteochondral lesions of the femoral head: is costal cartilage the answer?
The principles of evidence-based medicine (EBM) are the foundation of modern medical practice. Surgeons are familiar with the commonly used statistical techniques to test hypotheses, summarize findings, and provide answers within a specified range of probability. Based on this knowledge, they are able to critically evaluate research before deciding whether or not to adopt the findings into practice. Recently, there has been an increased use of artificial intelligence (AI) to analyze information and derive findings in orthopaedic research. These techniques use a set of statistical tools that are increasingly complex and may be unfamiliar to the orthopaedic surgeon. It is unclear if this shift towards less familiar techniques is widely accepted in the orthopaedic community. This study aimed to provide an exploration of understanding and acceptance of AI use in research among orthopaedic surgeons. Semi-structured in-depth interviews were carried out on a sample of 12 orthopaedic surgeons. Inductive thematic analysis was used to identify key themes.Aims
Methods
Early large treatment effects can arise in small studies, which lessen as more data accumulate. This study aimed to retrospectively examine whether early treatment effects occurred for two multicentre orthopaedic randomized controlled trials (RCTs) and explore biases related to this. Included RCTs were ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation), a two-arm study of surgery versus non-surgical treatment for proximal humerus fractures, and UK FROST (United Kingdom Frozen Shoulder Trial), a three-arm study of two surgical and one non-surgical treatment for frozen shoulder. To determine whether early treatment effects were present, the primary outcome of Oxford Shoulder Score (OSS) was compared on forest plots for: the chief investigator’s (CI) site to the remaining sites, the first five sites opened to the other sites, and patients grouped in quintiles by randomization date. Potential for bias was assessed by comparing mean age and proportion of patients with indicators of poor outcome between included and excluded/non-consenting participants.Aims
Methods
Open lower limb fracture is a life-changing injury affecting 11.5 per 100,000 adults each year, and causes significant morbidity and resource demand on trauma infrastructures. This study aims to identify what, and how, outcomes have been reported for people following open lower limb fracture over ten years. Systematic literature searches identified all clinical studies reporting outcomes for adults following open lower limb fracture between January 2009 and July 2019. All outcomes and outcome measurement instruments were extracted verbatim. An iterative process was used to group outcome terms under standardized outcome headings categorized using an outcome taxonomy.Aims
Methods
Initial treatment of traumatic spinal cord injury remains as controversial in 2023 as it was in the early 19th century, when Sir Astley Cooper and Sir Charles Bell debated the merits or otherwise of surgery to relieve cord compression. There has been a lack of high-class evidence for early surgery, despite which expeditious intervention has become the surgical norm. This evidence deficit has been progressively addressed in the last decade and more modern statistical methods have been used to clarify some of the issues, which is demonstrated by the results of the SCI-POEM trial. However, there has never been a properly conducted trial of surgery versus active conservative care. As a result, it is still not known whether early surgery or active physiological management of the unstable injured spinal cord offers the better chance for recovery. Surgeons who care for patients with traumatic spinal cord injuries in the acute setting should be aware of the arguments on all sides of the debate, a summary of which this annotation presents. Cite this article:
The aim of this study was to explore clinicians’ experience of a paediatric randomized controlled trial (RCT) comparing surgical reduction with non-surgical casting for displaced distal radius fractures. Overall, 22 staff from 15 hospitals who participated in the RCT took part in an interview. Interviews were informed by phenomenology and analyzed using thematic analysis.Aims
Methods
Hip fracture commonly affects the frailest patients, of whom many are care-dependent, with a disproportionate risk of contracting COVID-19. We examined the impact of COVID-19 infection on hip fracture mortality in England. We conducted a cohort study of patients with hip fracture recorded in the National Hip Fracture Database between 1 February 2019 and 31 October 2020 in England. Data were linked to Hospital Episode Statistics to quantify patient characteristics and comorbidities, Office for National Statistics mortality data, and Public Health England’s SARS-CoV-2 testing results. Multivariable Cox regression examined determinants of 90-day mortality. Excess mortality attributable to COVID-19 was quantified using Quasi-Poisson models.Aims
Methods
Loosening of components after total knee arthroplasty (TKA) can be associated with the development of radiolucent lines (RLLs). The aim of this study was to assess the rate of formation of RLLs in the cemented original design of the ATTUNE TKA and their relationship to loosening. A systematic search was undertaken using the Cochrane methodology in three online databases: MEDLINE, Embase, and CINAHL. Studies were screened against predetermined criteria, and data were extracted. Available National Joint Registries in the Network of Orthopaedic Registries of Europe were also screened. A random effects model meta-analysis was undertaken.Aims
Methods
Purpose: Non-steroidal anti-inflammatory drugs (NSAIDs) are powerful analgesics, frequently used for post-operative pain control. However, concerns regarding the potential deleterious effects of NSAIDs on bone healing have compelled many physicians to avoid NSAIDs in patients with fractures, osteotomies, and fusions. The purpose of this study was to systematically review and meta-analyze the best clinical evidence regarding the effects of NSAIDs on bone healing. Method: We performed a literature search for studies of fracture, osteotomy or fusion patients with NSAID exposure, and non-union as an outcome. Data on study design, patient characteristics and risk estimates were extracted. Pooled effect estimates were calculated. Study inclusion results were checked for evidence of publication bias. Metaregressions were performed to assess the impact of age, smoking, and study quality on reported risk of non-union. Results: Seven spine fusion and four long-bone fracture studies were included. A significant association between lower quality studies and higher reported odds ratios for non-union was identified. When only higher quality studies were considered, seven spine fusion studies were analyzed, and no statistically significant association between NSAID exposure and non-union was identified (OR=2.2, 95%CI:0.8, 6.3). No statistically significant association was found in sub-analysis of patients exposed to high dose IV/IM ketorolac (OR=2.0, 95%CI:0.4, 11.1), low dose IV/IM ketorolac (OR=1.2 95%CI:0.3, 4.5), or standard oral NSAIDs (OR=7.1, 95%CI:0.1, 520). In sub-analysis of the four most clinically relevant studies of adult spine fusion patients with well defined peri-operative NSAID exposure, no statistically significant association was found between NSAID exposure and risk of non-union (OR=0.8 95%CI:0.4, 1.4). Conclusion: Studies on NSAID exposure in long-bone healing settings were of lesser quality than studies in the spine fusion setting. Within the spine literature we could not demonstrate any increased risk of non-union with NSAID exposure.
Background: The major problem achieving lumbar spinal fusion is developing pseudarthrosis. At present the gold standard in achieving fusion is the use of autograft from pelvis or posterior elements of the spine. However the potential limitations of insuffient quantity and donor site morbidity have led to search for bone graft alternatives like DBM which contains osteinductive BMPs. Aims &
Methods: A Prospective
Introduction. The degeneration of the adjacent segment in lumbar spine with spondylodesis is well known, though the exact incidence and the mechanism is not clear. Several implants with semi rigid or dynamic behavior are available to reduce the biomechanical loads and to prevent an adjacent segment disease (ASD).
Study design:
Total hip arthroplasty (THA) is a very successful and cost-effective operation, yet debate continues about the optimum fixation philosophy in different age groups. The concept of the 'cementless paradox' and the UK 'Getting it Right First Time' initiative encourage increased use of cemented fixation due to purported lower revision rates, especially in elderly patients, and decreased cost. In a high-volume, tertiary referral centre, we identified 10,112 THAs from a prospectively collected database, including 1,699 cemented THAs, 5,782 hybrid THAs, and 2,631 cementless THAs. The endpoint was revision for any reason. Secondary analysis included examination of implant survivorship in patients aged over 70 years, over 75 years, and over 80 years at primary THA.Aims
Methods