Aims

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.

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.

Introduction

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.

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.

Background

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.

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.

INTRODUCTION

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.

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.

Introduction

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.

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.

Purpose: Post-operative analgesia using opioids or epidural analgesia can be associated with troublesome side effects. Effective peri-operative analgesia facilitates rehabilitation, improves patient satisfaction and may reduce hospital stay. Locally administered analgesia is effective, avoids systemic drug related side-effects and may be of benefit in minimally invasive joint replacement. This study compares the effects of a peri-articular injection cocktail in patients undergoing total knee and hip replacement surgery

Methods: 128 patients undergoing total knee (TKR) and hip (THR) replacement were randomised to receive a peri-articular intra-operative injection containing ropivacaine, ketorolac, epimorphine and epinephrine or nothing. The anaesthetic analgesic regime was standardised. All patients received patient controlled analgesia (PCA) for 24 hours post surgery, followed by standard analgesia. VAS pain scores during activity and at rest and patient satisfaction scores were recorded pre and post operatively and at 6 week follow up. PCA consumption and overall analgesic requirement were measured.

Results: Both TKR and THR patients used significantly less PCA 6 hours after surgery (p = 0.02 THR, p< 0.01 TKR). TKR patients receiving the injection used significantly less PCA use over 24 hours post surgery (p = 0.013). VAS for pain at 4 hrs post operation was significantly lower in the both groups (p = 0.003 TKR)(p = 0.017 THR). VAS for pain during activity at 24 hours was significantly less (p = 0.001) in the injected TKR group. Overall hospital stay and wound complications were not different between the groups.

Conclusions: Peri-articular analgesia significantly reduces post-operative analgesia requirement in TKR and THR patients. Greater satisfaction and pain relief was seen in TKR patients compared with THR.

Purpose

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.

Introduction : The purpose of the study is to compare in a randomised clinical double blind trial two methods of hamstring ACL reconstruction, the SIngle Bundle (SB) and the Double Bundle (DB).

Materials and methods: Seventy patients, with a chronic ACL insufficiency, were randomized to receive a unilateral single or double bundle ACL reconstruction. All the operations were performed by the same surgeon using the same two incision outside-in technique. The tibial guide wire was introduced with a 65 degrees Howell guide in extension to avoid impingment. To introduce the second tibial wire (posterolateral wire) a prototype guide that lets you place the wire with a fixed angulation and a fixed distance (9 mm) from the first was used. On the femoral side we used a modified Rear Entry guide. In a SB reconstruction the 10.00 o’clock position (right knee), intermediate between the two anatomic bundles, was used. In a DB reconstruction the first wire was placed in the anteromedial insertion area, close to the “over the top” position on the lateral wall and for the second wire the same prototype guide that gives you the correct angulation and distance with the first (10 mm) was used. The direction was chosen in order to exit 5 mm close to the posterior cartilage. The graft was prepared and pretensioned as to have two arms of the same diameter. It was fixed on the cortex of the tibia by means of a titanium ring bridge when doing a SB and looped around a cortical bony bridge when doing a DB. Tensioning and femoral fixation of the SB was done at 20 degrees, while in the DB tensioning and fixation of the PL bundle was achieved first after cycling at 10–15 degrees and of the AM bundle at 40–45 degrees. Femoral fixation was obtained via RCI titanium interference screws and one additional cortical titanium staple. The same moderately aggressive rehabilitation was utilized in both groups. Outcome assessment was performed by an indipendent observer, blinded to the involved leg and type of reconstruction, using the new IKDC form, the KOOS score, the KT-1000 arthrometer.

Results: All patients reached a minimum follow-up of one year. No difference was found in terms of overall KOOS and IKDC subjective scores. A significant difference was found (p< .001) in KT data and in IKDC final ojective scores (Excellent-A-result: 73% SB and 95% DB). he DB group showed a tred to less pivot shift (glide).

Conclusion: In the short period the DB reconstruction offered better knee stability and better objective results than the 10.00 o’clock SB. Longer follow up and accurate instrumented in vivo rotational stability assessment is probably needed to further disclose small but important differences.

Statement of purpose:

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.

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.

Background: Knee osteoarthritis is responsible for more chronic disability than any other medical condition. Quadriceps femoris muscle weakness has long been associated with disuse atrophy in symptomatic knee osteoarthritis but more recently implicated in the aetiology of this condition. The purpose of this study was to assess the benefits of two interventions aimed at increasing quadriceps strength in subjects with moderate to severe knee osteoarthritis.

Methods: Twenty-eight patients, aged 55–75 years, diagnosed with moderate to severe knee osteoarthritis were recruited and randomised to either a six-week home resistance-training exercise program or a six-week home neuromuscular electrical stimulation (NMES) program. An additional eleven patients matched for age, gender and osteoarthritis severity formed a control group, receiving standard care. The resistance-training group performed six exercises three times per week, while the NMES group used the garment stimulator at the maximum intensity tolerated for twenty minutes five times per week. Outcome measures included isometric and isokinetic quadriceps strength, functional capacity (25m walk test, chair rise test, stair climb test), Western Ontario and McMaster Osteoarthritis Index (WOMAC) and Short Form 36 (SF-36) health surveys. These measures were assessed at baseline, pre-intervention (after familiarisation), post-intervention and at 6-weeks post-intervention. Additionally, quadriceps cross-sectional area (via MRI) and muscle atrophy/hypertrophy gene expression (via vastus lateralis biopsy) were assessed pre- and post-intervention.

Results: Both intervention groups showed significant improvements in all functional tests (e.g. in the stair test, a 22% improvement in the exercise group versus 17% for the NMES group), in the SF36 health survey (25% & 22% respectively), and in quadriceps cross-sectional area (4.3% & 5.4%) immediately post-intervention. An increase in isokinetic strength was seen in the exercise group only (11%). WOMAC score improved only for the NMES group (19%). With the exception of isokinetic strength, all benefits were maintained six weeks post-intervention.

Conclusions: Both a six-week home resistance-training program and a six-week home NMES program produced significant improvements in functional performance as well as physical and mental health for patients with moderate to severe knee osteoarthritis. Home-based NMES is an acceptable alternative to physical therapy for patients with knee osteoarthritis, and is especially appropriate for patients who have difficulty complying with an exercise program.

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.

Purpose

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).

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.

Purpose: Despite the excellent results of total knee arthroplasty (TKA), controversy over whether or not to resurface the patella persists. Anterior knee pain, which occurs with variable frequency, continues to be a problem in a subset of the TKA patient population. Some clinicians advocate resurfacing all patellae while others cite the complications attributed to patellar resurfacing as reasons to avoid this aspect of the procedure. Still others favour selective resurfacing based on subjective criteria. To address this clinical controversy, we prospectively randomized patients receiving TKA into two groups, those receiving patellar resurfacing and those left without resurfacing to determine clinical outcomes and revisions at five and 10 years postoperatively. Our primary objective was to compare the revision rate following TKA between the two study groups. Secondarily, we compared pain and function at five and 10 years and knee range of motion (ROM) over the first year.

Method: Patients receiving TKA were prospectively enrolled in the study and randomized intraoperatively to either receive patellar resurfacing or have no patellar intervention. All surgeries were performed through the standard medial parapatellar approach. The Smith and Nephew Profix TKA system was implanted in all cases and all subjects followed a standardized post-operative regimen. Subjects were assessed pre-operatively and at 6 months, 1, 3, 5 and 10 years postoperatively for knee ROM, function, and pain using the WOMAC and SF-36 questionnaires. Re-operations and revisions were also documented.

Results: Thirty-nine patients were enrolled in the study. There was 83% patient retention at five years and 74% at 10 years. Study groups were similar in baseline characteristics. At five years, three (18%) revisions had been performed in the retained patella group and one (5%) in the resurfaced group (p=0.31). There were no further revisions between five and 10 years. ROM was similar between the groups at all evaluations (p> 0.05). SF-36 and WOMAC scores demonstrated that both groups improved their pain and function significantly following surgery (p< 0.04).

Conclusion: The decision whether or not to resurface the patella during TKA remains controversial. This study demonstrated that initial results with either technique are comparable, but it appears that there may be clinically significant differences by five years postoperatively. These trends continued throughout the study and were statistically significant at the 10 year mark. Revision surgery was required in 18% of the retained group compared to 5% in the re-surfaced group.