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Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_8 | Pages 9 - 9
1 Apr 2017
Wylde V Lenguerrand E Gooberman-Hill R Beswick A Marques E Noble S Horwood J Pyke M Dieppe P Blom A
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Background. Total hip replacement (THR) and total knee replacement (TKR) are usually effective at relieving pain; however, 7–23% of patients experience chronic post-surgical pain. These trials aimed to investigate the effect of local anaesthetic wound infiltration on pain severity at 12 months after primary THR or TKR for osteoarthritis. Methods. Between November 2009 and February 2012, 322 patients listed for THR and 316 listed for TKR were recruited into a single-centre double-blind randomised controlled trial. Participants were randomly assigned (1:1) to receive local anaesthetic infiltration and standard care or standard care alone. Participants and outcomes assessors were masked to group allocation. The primary outcome was pain severity on the WOMAC Pain scale at 12 months post-surgery. Analyses were conducted using intention-to-treat and per-protocol approaches. Ethics approval was obtained from Southampton and South West Hampshire Research Ethics Committee. Results. In the hip trial, patients in the intervention group had significantly less pain at 12 months post-operative than patients in the standard care group (differences in means 4.74; 95% CI 0.95, 8.54; p=0.015), although the difference was not clinically significant. Post-hoc analysis found that patients in the intervention group were more likely to have none to moderate pain than severe pain at 12 months than those in the standard care group (odds ratio 10.19; 95% CI 2.10, 49.55; p=0.004). In the knee trial, there was no strong evidence that the intervention influenced pain severity at 12 months post-operative (difference in means 3.83; 95% CI −0.83, 8.49; p=0.107). Conclusions. In conclusion, routine use of infiltration could be beneficial in improving long-term pain relief for some patients after THR. Level of evidence. Randomised controlled trial. Funding. This article presents independent research funded by the National Institute for Health Research (NIHR) in England under its Programme Grants for Applied Research programme (RP-PG-0407-10070). The views expressed in this article are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. The research team acknowledge the support of the NIHR, through the Comprehensive Clinical Research Network


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_11 | Pages 240 - 240
1 Jul 2014
Bhattacharjee A Kuiper J Harrison P Roberts S Richardson J
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Summary. Randomised controlled study evaluating new bone formation in vivo in fracture non-unions by bone marrow derived stromal cells (BMSC). These cells do not show statistically significant new bone formation. Age of the patient during fracture, diabetes and doubling time had been observed to be correlated with fracture healing. Introduction. Regenerating new bone by cell therapy could provide therapeutic options in many conditions such as fracture non-unions and osteo-chondral defect regeneration in advance OA. In this randomised controlled study we evaluated the efficacy of new bone formation by bone marrow derived stromal cells (BMSC) in patients with non-union. Methods. An ethically approved and adequately powered single centre randomised control trial recruited 35 patients for treatment of non-unions with BMSC. Bone marrow was harvested and autologous BMSC were culture expanded in autologous serum at our local MHRA-licensed facility (Oscell, Oswestry, UK). Following selection by adherence and in vitro culture expansion using autologous serum, cells in serum and serum alone was randomised for insertion at one of the two fracture sides by StratOs® computer software. Patients and the operating surgeon were blinded to the side of cell insertion. Such method of randomisation created internal controls at the fracture sites- one side receiving the cell (‘test side’) and other, not (‘control’). Serial radiographs extending up to an average of twelve months were evaluated by four independent assessors blinded to side of cell insertion. Callus formation and bridging of fracture was compared for ‘test’ and ‘control’ side. Radiological and clinical outcome at final follow-up was also noted. Results. Thirty five patients were recruited (21 males, 14 females; mean age 51.2±13.2SD). The mean duration of non-union was 3±2SD years, with a mean 3.5 (range 1–12) surgical interventions prior to BMSC insertion. Five patients had diabetes. New callus formation and fracture bridging was slow, with no significant difference between the cell-insertion and control side although a substantial improvement in fracture bridging/formation of new callus was noted at 9–12 months. Fracture union was achieved in 21 patients at final follow-up with failure to progress to union in 14 patients. Age at accident, having diabetes and cell doubling time during culture predicted union (r2=0.63, p=0.017). There was no reported adverse effects from the trial. Conclusion. The study concluded that patient biology predicts the final outcome in cases with non-union of fracture. Slower doubling time during in vitro expansion can be significantly correlated with failure to unite in addition to diabetes and age of the patient. BMSC's are safe option for cell therapy in a setting of non-union although it failed to show statistically significant difference of new bone formation or fracture bridging for up to one year


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_9 | Pages 58 - 58
1 May 2017
Akimau P Dakin W Cawthron K Chadwick C Blundell C Davies M
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Background

Avulsion fractures of the base of the fifth metatarsal are some of the commonest foot injuries. The robust scientific evidence on the optimal non-operative treatment of these fractures is scant. We designed and conducted a prospective randomised non-inferiority controlled trial of symptomatic treatment versus cast immobilisation with the null hypothesis that cast immobilisation gave substantial benefit over the symptomatic treatment in terms of patient reported outcome measures(PROMs). The alternative hypothesis was that symptomatic treatment was not inferior.

Methods

The primary outcome was the validated Visual Analogue Scale Foot and Ankle (VAS FA) score ranging from 0 to 100. The non-inferiority boundary was set at −10 points. Power sizing determined a minimum of 12 patients per group. Anticipating a significant loss to follow up, 60 patients of 16 years of age or older were randomised to receive either below knee walking cast immobilisation (n = 24) or symptomatic double- elasticated bandage (n = 36) for 4 weeks. Secondary outcome measures were EuroQol-5D, and American Orthopaedic Foot and Ankle Society scores. Data was analysed at the baseline, 4 weeks, 3 months and 6 months post injury by a clinician blinded to a treatment arm.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_1 | Pages 109 - 109
1 Jan 2017
van Hamersveld K Valstar E Toksvig-Larsen S
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Whether it is best to retain the posterior cruciate ligament in the degenerated knee, i.e. using a cruciate-retaining (CR) total knee prosthesis (TKP), or to use a more constraint posterior-stabilized (PS) TKP is of debate. There are limited studies comparing the effect of both methods on implant fixation and clinical outcome, leaving it up to the surgeon to base this decision on anything but conclusive evidence. We assessed the effect of two different philosophies in knee arthroplasty on clinical outcome and tibial component migration measured with radiostereometric analysis (RSA), by directly comparing the CR and PS version of an otherwise similarly designed cemented TKP.

Sixty patients were randomized and received a Triathlon TKP (Stryker, NJ, USA) of either CR (n=30) or PS (n=30) design. RSA measurements (primary outcome) and clinical scores including the Knee Society Score and Knee injury and Osteoarthritis Outcome Score were evaluated at baseline, at three months postoperatively and at one, two, five and seven years. A linear mixed-effects model was used to analyse the repeated measurements.

Both groups showed a similar implant migration pattern, with a maximum total point motion at seven years follow-up of around 0.8 mm of migration (mean difference between groups 95% CI −0.11 to 0.15mm, p=0.842). Two components (one of each group) were considered to have an increased risk of aseptic loosening. Both groups improved equally after surgery on the KSS and KOOS scores and no differences were seen during the seven years of follow-up.

No differences in implant migration nor clinical results were seen seven years after cruciate-retaining compared to posterior-stabilized total knee prostheses.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_4 | Pages 26 - 26
1 Jan 2013
Tilbrook H Cox H Hewitt C Chuang L Jayakody S Kanǵombe A Aplin J Semlyen A Trewhela A Watt I Torgerson D
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Purposes of the study and background

Smaller studies indicate that yoga may be an effective treatment for chronic low back pain. We conducted a randomised trial to evaluate if yoga compared to usual care improves back function in patients with chronic or recurrent low back pain.

Summary of the methods used and the results

Outcomes were assessed by postal questionnaires. The setting was 13 non-National Health Service premises. We recruited 313 adults with chronic or recurrent low back pain from primary care. 157 were randomised to usual care. 156 were randomised to a 12-class, gradually-progressing programme of yoga delivered by 12 teachers over three months. All received The Back Book.

Primary outcome was back function (Roland Morris Disability Score) at three months. Secondary outcomes: back function at six and 12 months, back pain, pain self-efficacy and general health.

Back function improved more in the yoga group: mean difference in changes from baseline at three (−2.17, 95% CI −3.31 to −1.03, p<0.001), six (−1.48, 95% CI −2.62 to −0.33, p=0.011) and 12 months (−1.57, −2.71 to −0.42, p=0.007). Improvement in pain self-efficacy at three and six months in the yoga group. No differences in general health and pain reduction.

Two adverse events were reported by controls and 12 by the yoga group – 8 out of 12 reported pain which may have been due to yoga. 63 (40%) were not fully compliant with treatment and 23 (15%) did not attend any yoga classes.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_11 | Pages 5 - 5
1 Jul 2014
Porter A Snyder B Franklin P Ayers D
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Summary Statement

A prospective randomised evaluation of primary TKA utilizing patient specific instruments demonstrated great accuracy of bone resection, improved sagittal alignment and the potential to improve functional outcomes and reduce operating room costs when compared to standard TKA instrumentation.

Introduction

Patient specific instruments (PSI), an alternative to standard total knee arthroplasty (TKA) technology, have been proposed to improve the accuracy of TKA implant placement and post-operative limb alignment. Previous studies have shown mixed results regarding the effectiveness of PSI. The purposes of this study were (1) to evaluate the accuracy of the pre-operative predicted PSI plan compared to intra-operative TKA resection measurements, (2) to compare patient-reported outcome measures of PSI and standard TKA patients, and (3) to compare the incremental cost savings with PSI.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_17 | Pages 21 - 21
1 Apr 2013
Wardlaw D Vadhva M Sabboubeh A
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Purpose of the Study

Assessment of long term results of Chemonucleolysis vs. surgery for soft disc herniation

Material and Methods

From 1982 to 1985, 100 patients with symptomatic disc herniation were randomly allocated to receive either Chemonucleolysis(48) or surgery(52) after a three months trial of conservative treatment. Ten of the chemonucleolysis had surgery. At 10–13 year follow up, Sixty one of the original 100 patients responded, (32 chemonucleolysis; 29 surgery). At 25–27 year Forty four patients responded (24 chemonucleolysis; 20 surgery). Clinical outcome at one year was according to a self-assessment questionnaire: Completely, better improved, the same, or worse, and at the later follow up periods, according to the Macnab criteria. The results of two groups of patients were compared using Chi square and T test for independent samples.

The disc height of the affected disc was measured from the lateral lumbar spine radiograph taken pre-operatively, and at the later two time points, and compared to a normal adjacent disc expressed as a percentage.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVI | Pages 39 - 39
1 Aug 2012
Alvand A Auplish S Gill H Rees J
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Background

The ability to learn arthroscopic surgery is an important aspect of modern day orthopaedic surgery. Knowing that variation in innate ability exists amongst medical students, the aim of this study was to investigate the effect of training on the arthroscopic surgical performance of our future orthopaedic surgeons (medical students).

Methods

Two arthroscopic tasks (one shoulder and one knee) were set up in a bioskills laboratory to represent core skills required for arthroscopic training. Thirty three medical students with no previous arthroscopic surgery experience were randomised to a ‘Trained’ (n=16) and ‘Non-trained’ (n=17) cohort. Both groups watched an instructional video. The Trained cohort also received specific training on the tasks prior to their first episode. Thirty episodes of each task were then undertaken. The primary outcome variable was success or failure. Individuals were assessed as ‘competent’ if they stabilised their learning curve within 20 episodes. The secondary outcome measure was an objective assessment of technical dexterity using a validated Motion Analysis system (time taken to complete tasks, total path length of the subject's hands, and number of hand movements).


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXVIII | Pages 44 - 44
1 Jun 2012
Smith J Hussain S Horey L Patil S Meek R
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Hip resurfacing has generally been used in younger patients with early osteoarthritis of the hip. There has been considerable recent interest in this over the past few years. We conducted a prospective randomised trial comparing 2 hip resurfacing implants, Durom and ASR looking at radiological and clinical outcomes.

Forty-nine patients (78% male) with hip osteoarthritis which met the criteria for hip resurfacing were randomised to receive either a Durom or ASR resurfacing implant. These patients have so far been followed up for a minimum of one year. The groups were comparable in age (p=0.124) and gender (p=0.675). The average age in the ASR group was 54.04 years and in the Durom group it was 51.25.

Radiological views were scrutinised immediately post op and at final follow up so far to look at cup inclination, stem-shaft angle, and acetabular osseointegration.

Clinical outcomes were compared using the Oxford hip scores, WOMAC scores and SF12 scores.

At minimum follow up of 1 year the mean post operative Oxford hip score was not significantly different between the Durom (45.32, SD 3.93) and ASR (43.44, SD 8.44). The mean post operative WOMAC score was also not significantly different between the Durom (52.56, SD 6.06) and ASR (49.63, SD 2.23). There was no difference between the groups with regards to signs of osseointegration from radiological assessment (p=0.368). There were 3 periprosthetic femoral neck fractures (5.7%) and one revision for pain.

We conclude from this trial that there is no difference in the clinical or radiological findings between the Durom and ASR implants.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_2 | Pages 113 - 113
1 Jan 2017
Boriani F Granchi D Roatti G Merlini L Sabattini T Baldini N
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The postoperative course of median nerve decompression in the carpal tunnel syndrome may sometimes be complicated by postoperative pain, paresthesias, and other unpleasant symptoms, or be characterized by a slow recovery of nerve function due to prolonged preoperative injury causing extensive nerve damage.

The aim of this study is to explore any possible effects of alpha lipoic acid (ALA) in the postoperative period after surgical decompression of the median nerve at the wrist.

Patients were enrolled with proven carpal tunnel syndrome and randomly assigned into one of two groups: Group A: surgical decompression of the median nerve followed by ALA for 40 days. Group P: surgical decompression followed by placebo. The primary endpoint of the study was nerve conduction velocity at 3 months post surgery, Other endpoints were static 2 point discrimination, the Boston score for hand function, pillar pain and use of pain killers beyond the second postoperative day.

ALA did not show to significantly improve nerve conduction velocity or Boston score. However, a statistically significant reduction in the postoperative incidence of pillar pain was noted in Group A. In addition, static 2 point discrimination showed to be significantly improved by ALA.

Administration of ALA following decompression of the median nerve for carpal tunnel release is effective on nerve recovery, although this is not detectable through nerve conduction studies but in terms of accelerated and improved static two-point discrimination.

The use of ALA as a supplementation for nerve recovery after surgical decompression may be extended to all types of compression syndromes or conditions where a nerve is freed from a mechanical insult.

Furthermore, ALA limits post-decompression pain, including late pericicatricial pain at the base of the palm, the so called pillar pain, which seems to be associated with a reversible damage to the superfical sensitive small nerve fibers.

In conclusion postoperative administration of ALA for 40 days post-median nerve decompression was positively associated with nerve recovery, induced a lower incidence of postoperative pillar pain and was associated with a more rapid improvement of static two-point discrimination. This treatment is well tolerated and associated with high levels of satisfaction and compliance, supporting its value as a standard postoperative supplementation after carpal tunnel decompression.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_2 | Pages 70 - 70
1 Jan 2017
Wylde V Marques E Artz N Blom A Gooberman-Hill R
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Total hip replacement (THR) is a common elective surgical procedure and can be effective for reducing chronic pain. However, waiting times for THR can be considerable, and patients often experience significant pain during this time. A pain self-management intervention may provide patients with the skills to enable them to manage their pain and its impact more effectively before surgery. However, studies of arthritis self-management programmes have faced challenges because of low recruitment rates, poor intervention uptake, and high attrition rates. This study aimed to evaluate the feasibility of a randomised controlled trial (RCT) to assess the effectiveness and cost-effectiveness of a group-based pain self-management course for patients undergoing THR. Specific objectives were to assess trial design, ascertain recruitment and retention rates, identify barriers to participation, refine data collection methods, and evaluate uptake and patient satisfaction with the course.

Patients listed for THR in an elective orthopaedic centre Bristol, UK were sent a postal invitation about the study. Participants were randomised to attend a pain self-management course plus standard care or standard care only using a computer-generated randomisation system. The pain self-management course was delivered by Arthritis Care and consisted of two half-day group sessions prior to surgery and one full-day group session 2–4 months after surgery. A structured course evaluation questionnaire was completed by participants.

Outcomes assessment was by postal questionnaire prior to surgery and 1-month, 3-months and 6-months after surgery. Self-report resource use data were collected using a diary prior to surgery and inclusion of resource use questions in the 3-month and 6-month post-operative questionnaires. Brief telephone interviews were conducted with non-participants to explore barriers to participation.

Postal invitations were sent to 385 eligible patients and 88 patients consented to participate (23% recruitment rate). Participants had a mean age of 66 years and 65% were female. Brief interviews with 57 non-participants revealed the most common reasons for non-participation were perceptions about the intervention and difficulties in getting to the hospital for the course.

Of the 43 patients randomised to the intervention group, 28 attended the pre-operative pain self-management sessions and 11 attended the post-operative sessions. Participant satisfaction with the course was high, and patients enjoyed the group format.

Retention of participants was acceptable, with 83% completing follow-up. Questionnaire return rates were high (76–93%), with the exception of the pre-operative resource use diary (35%). Completion rates for the resource use questions varied by category and allowed for an economic perspective from the health and social care payer to be taken.

Undertaking feasibility work for a RCT is labour-intensive; however this study highlights the importance of conducting such work. Postal recruitment resulted in a low recruitment rate and brief interviews with non-participants provided valuable information on barriers to participation. Embedding collection of resource use data within questionnaires resulted in higher completion rates than using resource use diaries. While patients who attended the course gave positive feedback, attendance was low. Findings from this feasibility study enable us to design successful definitive group-based RCTs in the future.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_11 | Pages 136 - 136
1 Jul 2014
Penny J Ding M Ovesen O Varmarken J Overgaard S
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Summary

Despite high revision rates, the mean two year migration of the ASRTM cup is within an acceptable threshold. Slightly higher migration rates found for the M2a- Magnum™ Porous Coated Acetabular Component but longer follow up is needed to establish if this implant is at risk.

Introduction

RSA can detect the migration of an implant, and continuous migration is a predictor for failure (1). The ASRTM resurfacing implant was withdrawn from the marked due to excessive failure rate but showed initial femoral component stability. The aim of this study was to investigate the initial implant stability for the ASR cup as a possible explanation for the high revision rate, and to compare it to another metal on metal (MoM) cup.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVI | Pages 105 - 105
1 Aug 2012
Downing M Hutchison J Ashcroft G
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Prosthesis migration and acetabular cup wear are useful short term measurement which may predict later implant outcome. However, the significance of the magnitude and pattern of the migration is very much dependent on the specific design studied. This study aimed to characterise patterns of migration by following four cemented femoral stem designs using Radiostereometry (RSA) within a prospective randomised longitudinal trial.

164 patients undergoing cemented femoral hip replacement for osteoarthritis were randomised to receive either an Exeter (Howmedica Stryker), Ultima Tapered Polished Stem (TPS) (Depuy), Ultima Straight Stem (USS) (Johnson and Johnson) or Elite Plus (Depuy) stem. Each subject received the OGEE PE cemented acetabular component (Depuy). RSA examinations were performed at 1 week and 6, 12, 18, 24 and 60 months post surgery. They were analysed using the UMRSA system (RSA Biomedical AB, Umea, Sweden), and our local geometric stem measurement software. 149 patients had RSA measurements available to 2 years, and 96 patients to 5 years. Differences were analysed using mixed linear modelling (SPSS).

Median linear proximal cup wear rate reduced to a minimum of 0.02-0.06mm/year in year two. Between 2 and 5 years the wear rate increased, being significantly higher for the Elite.

Cup migration was small but continuous. At 2 years it was median 0.3mm proximally, increasing to 0.5 mm at 5 years. Median rotations were less than 0.3 degrees.

Proximal migration was positive and increasing at all time points for all stems. For the tapered polished designs, while the overall magnitude was significantly higher, the rate of migration significantly decreased, whereas for the other stem designs it did not.

The TPS stem showed a tendency for posterior tilt which was significant compared to the other stems at 5 years.

All stems tended to retroversion, with the USS significantly less than the others and the Elite showing and relative increase at 5 years.

In summary migration patterns are characterised by the stem design, including where there were only small changes between designs. We are now testing measured migrations as predictors of outcome, and will continue to follow this group of patients to 10 years.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XVIII | Pages 4 - 4
1 May 2012
Simpson D Kendrick B Hughes M Rushforth G Gill H Murray D
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Introduction

Primary mechanical stability is important with uncemented THR because early migration is reduced, leading to more rapid osseointegration between the implant and bone. Such primary mechanical stability is provided by the design features of the device. The aim of this study was to compare the migration patterns of two uncemented hip stems, the Furlong Active and the Furlong HAC stem; the study was designed as a randomised control trial. The implants were the Furlong HAC, which is an established implant with good long term results, and the Furlong Active, which is a modified version of the Furlong HAC designed to minimise stress concentrations between the implant and bone, and thus to improve fixation.

Materials and methods

The migration of 43 uncemented femoral components for total hip replacement was measured in a randomised control trial using Roentgen Stereophotogrammetric Analysis (RSA) over two years. Twenty-three Furlong HAC and twenty Furlong Active stems were implanted into 43 patients. RSA examinations were carried out post-operatively, and at six months, 12 months and 24 months post-operatively. The patients stood in-front of a purpose made calibration frame which contained accurately positioned radio-opaque markers. From the obtained images, the 3-D positions of the prosthesis and the host bone were reconstructed. Geometrical algorithms were used to identify the components of the implant. These algorithms allowed the femoral component to be studied without the need to attach markers to the prosthesis. The migration was calculated relative to the femoral coordinate system representing the anterior-posterior (A-P), medial-lateral (M-L) and proximal-distal (P-D) directions respectively. Distal migration was termed subsidence.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_11 | Pages 121 - 121
1 Jul 2014
Boonen B Schotanus M Kerens B van der Wegen W Kort N
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Summary

Alignment results did not differ between PSG and conventional instrumentation. A small reduction in operation time and blood loss was found with the PSG system, but is unlikely of clinical significance. Length of hospital stay was identical for both groups.

Introduction

Several techniques for aligning a TKA exist nowadays. Patient-specific guiding (PSG) has relatively recently been introduced to try to resolve the shortcomings of existing techniques while optimising the operative procedure. Still few reports have been published on the clinical outcome and on the peroperative results of this new technique. This prospective, double-blind, randomised controlled trial was designed to address the following research questions: 1. Is there a significant difference in outliers in alignment in the frontal and sagittal plane between PSG TKA and conventional TKA. 2. Is there a significant difference in operation time, blood loss and length of hospital stay between the 2 techniques.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_2 | Pages 118 - 118
1 Jan 2017
Beswick A Wylde V Marques E Lenguerrand E Gooberman-Hill R Noble S Pyke M Blom A
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Robust evidence on the effectiveness of peri-operative local anaesthetic infiltration (LAI) is required before it is incorporated into the pain management regimen for patients receiving total knee replacement (TKR). To assess the effectiveness of peri-operative LAI for pain management in patients receiving TKR we conducted a systematic review, fully powered randomised controlled trial (RCT) and economic evaluation.

We searched MEDLINE, Embase and Cochrane databases for RCTs of peri-operative LAI in patients receiving TKR. Two reviewers screened abstracts and extracted data. Outcomes were pain, opioid use, mobilisation, hospital stay and complications. Authors were contacted if required. When feasible, we conducted meta-analysis with studies analysed separately if a femoral nerve block (FNB) was provided.

In the APEX RCT, we randomised 316 patients awaiting TKR to standard anaesthesia which included FNB, or to the same regimen with additional peri-operative LAI (60mls 0.25% bupivacaine plus adrenaline). Post-operatively, all patients received patient-controlled morphine. The primary outcome was joint pain severity (WOMAC-Pain) at 12 months. Patients and outcome assessors were blinded to allocation.

Within APEX, cost-effectiveness was assessed from the health and social-care perspective in relation to quality adjusted life years (QALYs) and WOMAC-Pain at 12-months. Resource use was collected from hospital records and patient questionnaires.

In the systematic review, 23 studies including 1,439 patients were identified. Compared with patients receiving no intervention, LAI reduced WOMAC-Pain by standardised mean difference (SMD) −0.40 (95%CI −0.58, −0.22; p<0.001) at 24 hours at rest and by SMD −0.27 (95%CI −0.50, −0.05; p=0.018) at 48 hours during activity. In three studies there was no difference in pain at any time point between randomised groups where all patients received FNB. Patients receiving LAI spent fewer days in hospital, used less opioids and mobilised earlier. Complications were similar between groups. Few studies reported long-term outcomes.

In the APEX RCT, pain levels in hospital were broadly similar between groups. Overall opioid use was similar between groups. Time to mobilisation and discharge were largely dependent on local protocols and did not differ between groups. There were no differences in pain outcomes between groups at 12 months.

In the economic evaluation, LAI was marginally associated with lower costs. Using the NICE £20,000 per QALY threshold, the incremental net monetary benefit was £264 (95%CI, −£710, £1,238) and the probability of being cost-effective was 62%.

Although LAI appeared to have some benefit for reduced pain in hospital after TKR there was no evidence of pain control additional to that provided by femoral nerve block, however it would be cost-effective at the current NICE thresholds.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_2 | Pages 119 - 119
1 Jan 2017
Beswick A Wylde V Marques E Lenguerrand E Gooberman-Hill R Noble S Pyke M Blom A
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Robust evidence on the effectiveness of peri-operative local anaesthetic infiltration (LAI) is required before it is incorporated into the pain management regimen for patients receiving total hip replacement (THR). We assessed the effectiveness of LAI using a systematic review and a fully powered randomised controlled trial (RCT) with economic evaluation.

We searched MEDLINE, Embase and Cochrane databases for RCTs of peri-operative LAI in patients receiving THR. Two reviewers screened abstracts, extracted data, and liaised with authors. Outcomes were pain, opioid use, mobilisation, hospital stay and complications. If feasible, we conducted meta-analysis.

In the APEX RCT, we randomised 322 patients awaiting THR to receive additional peri-operative LAI (60mls 0.25% bupivacaine plus adrenaline) or standard anaesthesia alone. Post-operatively, all patients received patient-controlled morphine. The primary outcome was joint pain severity (WOMAC-Pain) at 12 months. Patients and outcome assessors were blinded to allocation.

Within APEX, cost-effectiveness was assessed from the health and social-care perspective in relation to quality adjusted life years (QALYs) and WOMAC-Pain at 12-months. Resource use was collected from hospital records and patient questionnaires.

In the systematic review, we identified 13 studies (909 patients). Patients undergoing THR receiving LAI experienced greater pain reduction at 24 hours at rest, standardised mean difference (SMD) −0.61 (95%CI −1.05, −0.16; p=0.008) and at 48 hours during activity, SMD −0.43 (95%CI −0.78, −0.09; p=0.014). Patients receiving LAI spent fewer days in hospital, used less opioids and mobilised earlier. Complications were similar between groups. Long-term outcomes were not a focus of these studies.

In the APEX RCT, pain levels in hospital were broadly similar between groups, probably due to patient-controlled analgesia. Opioid use was similar between groups. Time to mobilisation and discharge were largely dependent on local protocols and did not differ between groups. Patients receiving LAI were less likely to report severe pain at 12 months than those receiving standard care, odds ratio 10.2 (95%CI 2.1, 49.6; p=0.004). Complications were similar between groups.

In the economic evaluation, LAI was associated with lower costs and greater cost-effectiveness than standard care. Using a £20,000 per QALY threshold, the incremental net monetary benefit was £1,125 (95%CI £183, £2,067) and the probability of being cost-effective was greater than 98 %.

The evidence suggests that peri-operative LAI is a cost-effective intervention for reducing acute and chronic post-surgical pain after THR.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_13 | Pages 9 - 9
1 Mar 2013
Okoro T Maddison P Andrew J Lemmey A
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Introduction

Late (commenced 6 months to 4 years post-op) home-based progressive resistance training programs are proven to improve muscle strength and function after total hip replacement (THR). This study assessed whether early (commenced < 1 week post-op) HBPRT post-THR improves muscle mass, strength and function relative to routine physiotherapy rehabilitation (RPR) at up to 12 months follow up.

Methods

Prospective single blind randomized controlled study performed after ethical approval. 50 patients randomised to 6 week HBPRT (n=26) or RPR (n=24) postoperatively. Maximal voluntary contraction of the operated leg quadriceps in (MVCOLQ) in Newtons (N), sit to stands in 30 seconds (ST, number of repetitions), and the lean mass in grams of the operated leg (LM) were assessed preoperatively and at intervals up to 12 months postoperatively. Mixed model repeated measures ANOVA was used for statistical analysis.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_1 | Pages 68 - 68
1 Jan 2017
Penny J Ding M Ovensen O Overgaard S
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The metal on metal implants was introduced without the proper stepwise introduction. The ASR resurfacing hip arthroplasty (RHA) withdrawn due to high clinical failure rates and the large diameter head THA (LDH-THA) are also widely abandoned. Early (2 year) radiostereometry studies does not support early instability as cause of failure but more likely metal wear products. A possible advantage may be maintenance of bone mineral density (BMD).

We present 5 year prospective follow up from a randomized series, aiming to report changes from baseline and to investigate links between implant micromotion, Cr & Co ions and BMD.

Patients eligible for an artificial hip were randomized to RHA, Biomet LDH-THA or standard Biometric THA. 19, 17 and 15 patients completed 5 year follow-up. All followed with BMD of the femur, acetabulum and for RHA the collum. RHA and THA with whole blood Co and Co. LDH-THA only at 5 year. RHA had marker based RSA of both components, cup only for LDH-THA. Translations were compiled to total translation (TT= √(x2+y2+z2)). Data were collected at baseline, 8 weeks, 6 months, 1, 2 and 5 years.

Statistical tests: ANCOVA for TT movement, Spearman's correlation for BMD, Cr, Co and BMI to TT at 5 years

RSA: The 5 year median (25%to75%) RHA cup translations were X=-0.00(−0.49 to 0.19) Y=0.15(−0.03 to 0.20), z=0.24(−0.42 to 0.37) and TT 0.58 (0.16 to 1.82) mm. For the LDH-THA X=−0.33(−0.90 to 0.20) Y=0.28(0.02 to 0.54), z=0.43(−1.12 to −0.19) and TT 1.06 (0.97 to 1.72) mm. The TT was statistically different (p<0.05) for the two cups. The RHA femoral component moved X=0.37(0.21 to 0.56) Y=0.02(−0.07 to 0.11), z=-0.01(−0.07 to 0.26) and TT 0.48 (0.29 to 0.60) mm at 5 years. There was no TT movement from year 2.

The mean (SD) acetabular BMD was diminished to 93(90–97)% for RHA and 97(93–99.9)% for THA, but LDH-THA maintained 99(95–103)%. Overall femoral BMD was unchanged at 5 years for all interventions, but both stemmed implants lost 17% at the calcar.

Median (25%to75%) whole-blood Cr peaked in the LDH-THA group with 1.7 (0.9 to 3.1) followed by RHA 1.2 (0.8 to 5.0) and THA with 0.5 (0.4 to 0.7)ppb.

For Co the highest levels were found in RHA with 1.6(0.8 to 4.7) followed by LDH-THA 1.2 (0.7–1.7) and THA 0.2 (0.2 to 0.6) ppb.

The only correlations above +/−0.3 for TT were the RHA femoral component with a correlation of 0.47 to BMI, 0.30 to Co and Cr. The ASR cup conversely had a negative correlation of −0.60 to BMI and again, the LDH-THA cup had a negative correlation of −0.37 to Cr.

In contrast to registered revision rates, we found significantly larger movement for the Biomet cup than the ASR cup. The metal ion levels were similar. The LDH-THA cup maintained the acetabular BMD best at 5 years, but the difference was small, we are limited by small numbers and the correlations between TT and the covariates showed no clear pattern.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_30 | Pages 4 - 4
1 Aug 2013
Donaldson DQ Torkington M Jones B Blyth M
Full Access

Decreased oxygenation and delayed wound healing may negate the advantages of using a medial parapatellar incision in Total Knee Replacement. Tissue biochemical and blood flow data are not currently available in the literature.

20 patients were included in the study and randomised to midline or medial parapatellar skin incision groups, being supervised by one of 3 Consultant surgeons. Cutaneous blood flow was measured using a Speckle Contrast Blood Perfusion Imager at pre-operative and Days 1 & 3 post-operative intervals. Interstitial fluid measurements for lactate, pyruvate, lactate/pyruvate ratio and glucose were obtained from subcutaneous catheters with a dialysis membrane. Pre-operative samples were obtained from a catheter inserted into the prospective lateral wound edge. A catheter inserted after wound closure supplied dialysates at 0.5, 1, 2, 4, 6, 12 and 24-hour intervals. One catheter was corrupted on insertion; therefore the patients with biochemical data numbered 19.

Cutaneous blood flow improved over the 3 post-operative days in both types of incision and both sides, the medial retaining comparatively better flow. At Day 3, the parapatellar incision group displayed better flow on both sides of the wound. The concentration of lactate was highest in the parapatellar incision group of patients at all intervals. Pyruvate concentrations did not appear to differ across the incision types. Similarly, glucose concentrations did not appear to differ until after 4 hours, when higher concentrations were recorded in the midline group. Lactate/pyruvate ratio appeared to be notably greater in the parapatellar incision group. Plotting change in blood flow relative to change in lactate concentration demonstrated an increase in lactate as flow deteriorates.

The study findings suggest medial parapatellar incisions have increased anaerobic metabolites due to tissue hypoperfusion. Previous studies have demonstrated decreased oxygen tension in lateral based flaps and more recently the medial to lateral arterial anatomy has been demonstrated.