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.
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
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 aim of this trial was to assess the cost-effectiveness of a soft bandage and immediate discharge, compared with rigid immobilization, in children aged four to 15 years with a torus fracture of the distal radius. A within-trial economic evaluation was conducted from the UK NHS and personal social services (PSS) perspective, as well as a broader societal point of view. Health resources and quality of life (the youth version of the EuroQol five-dimension questionnaire (EQ-5D-Y)) data were collected, as part of the Forearm Recovery in Children Evaluation (FORCE) multicentre randomized controlled trial over a six-week period, using trial case report forms and patient-completed questionnaires. Costs and health gains (quality-adjusted life years (QALYs)) were estimated for the two trial treatment groups. Regression was used to estimate the probability of the new treatment being cost-effective at a range of ‘willingness-to-pay’ thresholds, which reflect a range of costs per QALY at which governments are typically prepared to reimburse for treatment.Aims
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.
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
In this randomised controlled trial, we evaluated
the role of elastic compression using ankle injury stockings (AIS)
in the management of fractures of the ankle. A total of 90 patients
with a mean age of 47 years (16 to 79) were treated within 72 hours
of presentation with a fracture of the ankle, 31 of whom were treated
operatively and 59 conservatively, were randomised to be treated
either with compression by AIS plus an Aircast boot or Tubigrip
plus an Aircast boot. Male to female ratio was 36:54. The primary
outcome measure was the functional Olerud–Molander ankle score (OMAS).
The secondary outcome measures were; the American Orthopaedic Foot
and Ankle Society score (AOFAS); the Short Form (SF)-12v2 Quality
of Life score; and the frequency of deep vein thrombosis (DVT). Compression using AIS reduced swelling of the ankle at all time
points and improved the mean OMAS score at six months to 98 (95%
confidence interval (CI) 96 to 99) compared with a mean of 67 (95%
CI 62 to 73) for the Tubigrip group (p <
0.001). The mean AOFAS
and SF-12v2 scores at six months were also significantly improved
by compression. Of 86 patients with duplex imaging at four weeks,
five (12%) of 43 in the AIS group and ten (23%) of 43 in the Tubigrip
group developed a DVT (p = 0.26). Compression improved functional outcome and quality of life following
fracture of the ankle. DVTs were frequent, but a larger study would
be needed to confirm that compression with AISs reduces the incidence
of DVT. Cite this article:
We undertook a randomised clinical trial to compare
treatment times and failure rates between above- and below-knee
Ponseti casting groups. Eligible children with idiopathic clubfoot,
treated using the Ponseti method, were randomised to either below-
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. A total of 26 children (33 feet) were entered into the trial.
The above-knee group comprised 17 feet in 13 children (ten boys
and three girls, median age 13 days (1 to 40)) and the below-knee
group comprised 16 feet in 13 children (ten boys and three girls,
median age 13 days (5 to 20)). Because of six failures (37.5%) in
the below-knee group, the trial was stopped early for ethical reasons.
The rate of failure 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). This study demonstrates that the use of a below-knee plaster
of Paris cast in conjunction with the Ponseti technique leads to
unacceptably high failure rates and significantly longer treatment
times. Therefore, this technique is not recommended. Cite this article:
A total of 159 patients (84 women and 75 men,
mean age of 53 (20 to 87)) with subacromial impingement were randomised
to treatment with subacromial injections using lidocaine with one
of hyaluronic acid (51 patients), corticosteroid (53 patients) or
placebo (55 patients). Patients were followed up for 26 weeks. The
primary outcome was pain on a visual analogue score (VAS), and secondary
outcomes included the Constant Murley score, shoulder pain score,
functional mobility score, shoulder disability questionnaire and
pain-specific disability score. The different outcome measures showed
similar results. After three, six and 12 weeks corticosteroid injections
were superior to hyaluronic acid injections and only at six weeks
significantly better than placebo injections. The mean short-term
reduction in pain on the VAS score at 12 weeks was 7% ( We were not able to show a convincing benefit from hyaluronic
acid injections compared with corticosteroid or placebo injections.
Corticosteroid injections produced a significant reduction in pain
in the short term (three to 12 weeks), but in the long term the
placebo injection produced the best results.
This study compared the outcome of total knee
replacement (TKR) in adult patients with fixed- and mobile-bearing prostheses
during the first post-operative year and at five years’ follow-up,
using gait parameters as a new objective measure. This double-blind
randomised controlled clinical trial included 55 patients with mobile-bearing (n
= 26) and fixed-bearing (n = 29) prostheses of the same design,
evaluated pre-operatively and post-operatively at six weeks, three
months, six months, one year and five years. Each participant undertook
two walking trials of 30 m and completed the EuroQol questionnaire,
Western Ontario and McMaster Universities osteoarthritis index,
Knee Society score, and visual analogue scales for pain and stiffness.
Gait analysis was performed using five miniature angular rate sensors
mounted on the trunk (sacrum), each thigh and calf. The study population
was divided into two groups according to age (≤ 70 years Improvements in most gait parameters at five years’ follow-up
were greater for fixed-bearing TKRs in older patients (>
70 years),
and greater for mobile-bearing TKRs in younger patients (≤ 70 years).
These findings should be confirmed by an extended age controlled
study, as the ideal choice of prosthesis might depend on the age
of the patient at the time of surgery.
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.