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Bone & Joint Open
Vol. 5, Issue 1 | Pages 20 - 27
17 Jan 2024
Turgeon TR Vasarhelyi E Howard J Teeter M Righolt CH Gascoyne T Bohm E

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.

Methods

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.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_2 | Pages 77 - 77
10 Feb 2023
Hooper G Thompson D Lash N Sharr J Faulkner D Frampton C Gilchrist N
Full Access

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.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_10 | Pages 32 - 32
1 Oct 2020
Yang J Terhune EB DeBenedetti A Della Valle CJ Gerlinger TL Levine BR Nam D
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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.

Methods

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 a priori power analysis determined 201 patients per cohort were necessary to demonstrate a 10% decrease in wound complication rate.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_3 | Pages 21 - 21
1 Mar 2021
Gottschalk M Dawes A Farley K Nazzal E Campbell C Spencer C Daly C Wagner E
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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.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_10 | Pages 56 - 56
1 Oct 2020
Lombardi AV Berend KR Huddleston J Crawford D Peters C VanAndel D Anderson M DeHaan A Southgate R Duwelius PJ
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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.

Methods

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.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_4 | Pages 1 - 1
1 Apr 2022
Karayiannis P Agus A Bryce L Hill J Beverland D
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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.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_5 | Pages 28 - 28
1 Jul 2020
Corten K Vanbiervliet J Vandeputte F
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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.

MATERIALS & METHODS

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.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_7 | Pages 1 - 1
1 May 2019
Nicholson J Clement N Goudie E Robinson C
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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.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_15 | Pages 83 - 83
1 Nov 2018
Flynn S O'Reilly M Feeley I Sheehan E
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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.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXI | Pages 61 - 61
1 May 2012
F. T M. W
Full Access

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.

Methods

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.


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_I | Pages 127 - 127
1 Mar 2008
Shore B Bourne R MacDonald S McCalden R Busch C Rorabeck C Bhandari R Ganapathy S
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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.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVIII | Pages 81 - 81
1 Sep 2012
Cheng O Thompson C McKee MD COTS COTS
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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.

Method

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.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_I | Pages 85 - 85
1 Mar 2009
Giron F Aglietti P Cuomo P Losco M Mondanelli N
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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.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_1 | Pages 13 - 13
1 Jan 2014
Maripuri S Gallacher P Bridgens J Kuiper J Kiely N
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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.

Methods and Results:

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).


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 545 - 545
1 Nov 2011
Jayasuriya R Buckley S Hamer A Kerry R Stockley I Tomouk M Wilkinson J
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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.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_II | Pages 116 - 117
1 May 2011
Bruce-Brand R Moyna N O’Byrne J
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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.


Orthopaedic Proceedings
Vol. 84-B, Issue SUPP_III | Pages 254 - 254
1 Nov 2002
Howie D Steele-Scott C Costi K McGee M
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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.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVIII | Pages 106 - 106
1 Sep 2012
Masri BA Garbuz DS Duncan CP VGreidanus N Bohm E Valle CJD Gross AE
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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).

Method

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 postoperatively


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_I | Pages 105 - 106
1 Mar 2008
Hall J
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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.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 565 - 565
1 Nov 2011
Secretan CC Beaupre L Johnston DWC Lavoie G
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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.


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_III | Pages 321 - 321
1 Sep 2005
MacDonald S Bourne R Rorabeck C Cleland D Chess D McCalden R
Full Access

Introduction and Aims: Polyethylene wear continues to be the most significant issue following total hip arthroplasty (THA), leading to the current increase in use of alternative bearing surfaces. We performed a prospective, randomised, blinded clinical trial comparing metal versus polyethylene bearing surfaces in patients receiving THA.

Method: Forty-one patients were randomised to receive a metal (23) or a polyethylene (18) insert with identical femoral and acetabular components. Patients were evaluated pre-operatively at three, six, 12 months and annually thereafter, including an evaluation of erythrocyte and 24-hour urine cobalt, chromium and titanium metal ion levels, validated outcome measures (WOMAC, SF-12, Harris Hip Score) and radiographs.

Results: No patients were lost to follow-up. One patient died of unrelated causes. At an average 4.4 (range 3.3–5.1) 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 the latest follow-up erythrocyte cobalt levels were seven times elevated (median 1.2μg/l (metal) Vs 0.18μg/l (poly), p< .001). Urine cobalt levels were 41 times elevated (median 11.9μg/day (metal) Vs 0.29μg/day (poly), p< .001) and urine chromium levels were 14 times elevated (median 4.9μg/day (metal) Vs 0.36μg/day (poly), p< .001). Erthrocyte chromium, titanium and urine titanium were not significantly different between groups. As well, contrary to previous reports, there was not a significant trend towards decreasing ion levels over time.

Conclusion: In this prospective randomised blinded clinical trail comparing metal to polyethyle bearing surfaces, both cobalt and chromium ion levels were significantly elevated in the blood and urine of the patients randomised to receive the metal on metal THA.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVIII | Pages 80 - 80
1 Sep 2012
Mohtadi N Kirkley (Deceased) A Hollinshead R Chan DS Hannaford H Fredine J Sasyniuk T Paolucci EO
Full Access

Purpose

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.

Method

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).


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_III | Pages 353 - 353
1 Sep 2005
Orec R Pitto R Schmidt R
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Introduction and Aims: Recently, concerns have emerged regarding the high stiffness of acetabular components inserted with alumina ceramic liners, which might potentially cause early migration and loosening. This study was designed to investigate in-vivo the migration pattern of these constructs

Method: Fifty patients (50 hips) operated on using the same surgical technique and the same prosthesis were randomised in two groups. The study group of hips was treated with an alumina ceramic liner, the control group of hips received a polyethylene liner. An alumina femoral head with a diameter of 28mm was used in all hips. Radiostereometric analysis (RSA) was performed to assess migration using serial follow-up radiographs.

Results: The median pre-operative Harris hip score (HHS) was rated 48.9 points in the alumina group, and 47.7 points in the polyethylene group. At the two-year follow-up, the median HHS of the alumina group was rated 94.1 points, and was rated 93.7 points in the polyethylene group. There were no clinical or radiological signs of aseptic loosening. RSA of the alumina group of cups showed a median axial displacement of 0.026 mm (SD 0.35mm). The median axial displacement of the polyethylene group was 0.047 mm (SD 0.26 mm) (p=0.9). The median tilting of the cup was 0.21 degrees (SD 0.54 degrees) in the alumina group, and 0.35 degrees (SD 0.71 degrees) in the polyethylene group (p=0.12).

Conclusion: At an average of two years post-operatively, the cups inserted with an alumina ceramic liner appeared stable, RSA showed low rates of non-progressive migration. Results did not differ from those observed using the same cup inserted with a polyethylene liner.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 338 - 338
1 May 2009
Tregonning G Fransen M Douglas J MacMahon S Norton R
Full Access

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.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 244 - 244
1 May 2009
Goel DP Chan D Mohtadi N Watson K
Full Access

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.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_III | Pages 273 - 274
1 Jul 2011
MacDonald SJ Engh CA Thompson AE Sritulanondha S Naudie D Engh CA
Full Access

Purpose: Metal-on-metal articulations are an increasingly popular choice as an alternate bearing surface in total hip arthroplasty (THA) and Resurfacing implants. One advantage of a metal-on-metal bearing is the use of larger diameter femoral heads with hip simulator data demonstrating reduced wear. We performed a prospective, multicentre, randomized, blinded clinical trial comparing 28mm to 36mm metal-on-metal bearings assessing multiple validated outcome measures and serum, erythrocyte and urine metal ions.

Method: Ninety-one patients were randomized to receive a metal-on-polyethylene (34), a 28mm metal-on-metal (25) or a 36mm metal-on-metal (32) insert. All patients received the same acetabular and femoral component. Patients were evaluated pre-operatively, at 6, 12 months and annually thereafter, including an evaluation of serum, erythrocyte and urine cobalt, chromium, and titanium, outcome measures (WOMAC, SF-12, Harris Hip Score) and radiographs.

Results: At a minimum two years follow-up there were no differences in WOMAC, SF-12, Harris Hip scores or radiographs. Patients receiving metal liners had significantly (p< 0.001) elevated metal ion measurements compared with the polyethylene control group, however there were no differences between the 28mm and 36mm metal-on-metal bearings (Median serum Co (mg/L): 0.14(poly), 0.77(28mm), 0.73(36mm). Median erythrocyte Co (mg/L): 0.11(poly), 0.42(28mm), 0.42(36mm). Median urine Co(mg/day): 0.44(poly), 4.55(28mm), 5.42(36mm)). (Median serum Cr(mg/L): 0.17(poly), 1.29(28mm), 0.91(36mm). Median erythrocyte Cr(mg/ L): 1.10(poly), 1.10(28mm), 1.20(36mm). Median urine Cr(mg/day): 0.27(poly), 1.92(28mm), 2.02(36mm)).

Conclusion: Both cobalt and chromium ion measurements were significantly elevated in the blood and urine of the patients randomized to receive the metal-on-metal bearings at all time intervals. There were no differences seen between the 28mm and 36mm metal-on-metal bearings, keeping all other variables identical. The larger diameter bearing therefore provides the potential clinical advantages of improved range of motion and stability, while providing a similar metal ion profile. While reduced wear is seen with larger diameter metal-on-metal bearings in-vitro, we could not demonstrate a reduction in blood or urine metal ion levels in-vivo.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 338 - 338
1 May 2009
Pitto R Pandit S Clatworthy M Walker C Munro J
Full Access

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.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 249 - 249
1 May 2009
Johnston D Al Yamani M Beaupre L Huckell JR
Full Access

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.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_I | Pages 42 - 43
1 Jan 2011
Maffulli N Franceschi F Longo U Ruzzini L Rizzello G Denaro V
Full Access

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.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVIII | Pages 159 - 159
1 Sep 2012
Beaulé PE Dinh L Gauthier L Kim PR Feibel RJ Thurston PR Giachino AA
Full Access

Purpose

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.

Method

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.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 254 - 254
1 May 2009
Roy L Carrier M Laflamme Y
Full Access

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.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_II | Pages 301 - 301
1 May 2010
Hordam B Soballe K Pedersen PU Sabroe S Mejdahl S
Full Access

Objective: To study the effect in health status of telephone contact 2+10 weeks after total hip replacement (THR) during the first nine months after surgery. Not all of patient have improvement in their health status and quality of life, that the surgery benefits them.

Method: A randomised clinical trial enrolled 180 patients aged 65+ focusing on patients’ health status using SF-36, 4 weeks pre–to 3 and 9 months postoperative were carried out. Patients were randomised 4 weeks preoperative either to control or intervention group. Both groups received the conventional treatment. Furthermore the intervention group had postoperative telephone monitoring two and ten weeks after surgery Patients were given counselling by using an interview-guide within eight main themes referring to patients’ actual situation after THR.

Results: All patients experienced increase in their health status after THA. The intervention significantly reduced the time for patients to reach their habitual level as patients in the intervention group reached their habitual level at three months whereas patients in the control group reached this level after nine months.

Conclusion: Support by phone contact after THR seems to benefit patients’ outcome.

The presentation is based on the results of the nursing intervention program by using telephone contact to elderly patients with hip replacement after discharge.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVIII | Pages 166 - 166
1 Sep 2012
Mohtadi NG Chan DS Hollinshead R Boorman R Hiemstra L Lo I Hannaford H Fredine J Sasyniuk T Paolucci EO
Full Access

Purpose

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.

Method

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.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXIX | Pages 1 - 1
1 Sep 2012
Ramaskandhan J Malviya A Bowman R Lingard E Holland J
Full Access

Introduction

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.

Patients and Methods

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.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVIII | Pages 203 - 203
1 Sep 2012
Soroceanu A Oxner W Alexander D Shakespeare D
Full Access

Purpose

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.

Method

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.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 239 - 239
1 May 2009
MacDonald S Bourne RB Chess D McCalden RW Rorabeck CH Thompson A
Full Access

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.


The Bone & Joint Journal
Vol. 106-B, Issue 2 | Pages 114 - 120
1 Feb 2024
Khatri C Metcalfe A Wall P Underwood M Haddad FS Davis ET

Total hip and knee arthroplasty (THA, TKA) are largely successful procedures; however, both have variable outcomes, resulting in some patients being dissatisfied with the outcome. Surgeons are turning to technologies such as robotic-assisted surgery in an attempt to improve outcomes. Robust studies are needed to find out if these innovations are really benefitting patients. The Robotic Arthroplasty Clinical and Cost Effectiveness Randomised Controlled Trials (RACER) trials are multicentre, patient-blinded randomized controlled trials. The patients have primary osteoarthritis of the hip or knee. The operation is Mako-assisted THA or TKA and the control groups have operations using conventional instruments. The primary clinical outcome is the Forgotten Joint Score at 12 months, and there is a built-in analysis of cost-effectiveness. Secondary outcomes include early pain, the alignment of the components, and medium- to long-term outcomes. This annotation outlines the need to assess these technologies and discusses the design and challenges when conducting such trials, including surgical workflows, isolating the effect of the operation, blinding, and assessing the learning curve. Finally, the future of robotic surgery is discussed, including the need to contemporaneously introduce and evaluate such technologies.

Cite this article: Bone Joint J 2024;106-B(2):114–120.


The Bone & Joint Journal
Vol. 106-B, Issue 4 | Pages 401 - 411
1 Apr 2024
Carrothers A O'Leary R Hull P Chou D Alsousou J Queally J Bond SJ Costa ML

Aims

To assess the feasibility of a randomized controlled trial (RCT) that compares three treatments for acetabular fractures in older patients: surgical fixation, surgical fixation and hip arthroplasty (fix-and-replace), and non-surgical treatment.

Methods

Patients were recruited from seven UK NHS centres and randomized to a three-arm pilot trial if aged older than 60 years and had a displaced acetabular fracture. Feasibility outcomes included patients’ willingness to participate, clinicians’ capability to recruit, and dropout rates. The primary clinical outcome measure was the EuroQol five-dimension questionnaire (EQ-5D) at six months. Secondary outcomes were Oxford Hip Score, Disability Rating Index, blood loss, and radiological and mobility assessments.


Bone & Joint Open
Vol. 5, Issue 7 | Pages 550 - 559
5 Jul 2024
Ronaldson SJ Cook E Mitchell A Fairhurst CM Reed M Martin BC Torgerson DJ

Aims

To assess the cost-effectiveness of a two-layer compression bandage versus a standard wool and crepe bandage following total knee arthroplasty, using patient-level data from the Knee Replacement Bandage Study (KReBS).

Methods

A cost-utility analysis was undertaken alongside KReBS, a pragmatic, two-arm, open label, parallel-group, randomized controlled trial, in terms of the cost per quality-adjusted life year (QALY). Overall, 2,330 participants scheduled for total knee arthroplasty (TKA) were randomized to either a two-layer compression bandage or a standard wool and crepe bandage. Costs were estimated over a 12-month period from the UK NHS perspective, and health outcomes were reported as QALYs based on participants’ EuroQol five-dimesion five-level questionnaire responses. Multiple imputation was used to deal with missing data and sensitivity analyses included a complete case analysis and testing of costing assumptions, with a secondary analysis exploring the inclusion of productivity losses.


Aims

Arthroscopic microfracture is a conventional form of treatment for patients with osteochondritis of the talus, involving an area of < 1.5 cm2. However, some patients have persistent pain and limitation of movement in the early postoperative period. No studies have investigated the combined treatment of microfracture and shortwave treatment in these patients. The aim of this prospective single-centre, randomized, double-blind, placebo-controlled trial was to compare the outcome in patients treated with arthroscopic microfracture combined with radial extracorporeal shockwave therapy (rESWT) and arthroscopic microfracture alone, in patients with ostechondritis of the talus.

Methods

Patients were randomly enrolled into two groups. At three weeks postoperatively, the rESWT group was given shockwave treatment, once every other day, for five treatments. In the control group the head of the device which delivered the treatment had no energy output. The two groups were evaluated before surgery and at six weeks and three, six and 12 months postoperatively. The primary outcome measure was the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale. Secondary outcome measures included a visual analogue scale (VAS) score for pain and the area of bone marrow oedema of the talus as identified on sagittal fat suppression sequence MRI scans.


The Bone & Joint Journal
Vol. 106-B, Issue 1 | Pages 38 - 45
1 Jan 2024
Leal J Mirza B Davies L Fletcher H Stokes J Cook JA Price A Beard DJ

Aims

The aim of this study was to estimate the incremental use of resources, costs, and quality of life outcomes associated with surgical reconstruction compared to rehabilitation for long-standing anterior cruciate ligament (ACL) injury in the NHS, and to estimate its cost-effectiveness.

Methods

A total of 316 patients were recruited and randomly assigned to either surgical reconstruction or rehabilitation (physiotherapy but with subsequent reconstruction permitted if instability persisted after treatment). Healthcare resource use and health-related quality of life data (EuroQol five-dimension five-level health questionnaire) were collected in the trial at six, 12, and 18 months using self-reported questionnaires and medical records. Using intention-to-treat analysis, differences in costs, and quality-adjusted life years (QALYs) between treatment arms were estimated adjusting for baseline differences and following multiple imputation of missing data. The incremental cost-effectiveness ratio (ICER) was estimated as the difference in costs divided by the difference in QALYs between reconstruction and rehabilitation.


The Bone & Joint Journal
Vol. 104-B, Issue 11 | Pages 1256 - 1265
1 Nov 2022
Keene DJ Alsousou J Harrison P O’Connor HM Wagland S Dutton SJ Hulley P Lamb SE Willett K

Aims

To determine whether platelet-rich plasma (PRP) injection improves outcomes two years after acute Achilles tendon rupture.

Methods

A randomized multicentre two-arm parallel-group, participant- and assessor-blinded superiority trial was undertaken. Recruitment commenced on 28 July 2015 and two-year follow-up was completed in 21 October 2019. Participants were 230 adults aged 18 years and over, with acute Achilles tendon rupture managed with non-surgical treatment from 19 UK hospitals. Exclusions were insertion or musculotendinous junction injuries, major leg injury or deformity, diabetes, platelet or haematological disorder, medication with systemic corticosteroids, anticoagulation therapy treatment, and other contraindicating conditions. Participants were randomized via a central online system 1:1 to PRP or placebo injection. The main outcome measure was Achilles Tendon Rupture Score (ATRS) at two years via postal questionnaire. Other outcomes were pain, recovery goal attainment, and quality of life. Analysis was by intention-to-treat.


Bone & Joint Open
Vol. 3, Issue 11 | Pages 898 - 906
15 Nov 2022
Dakin H Rombach I Dritsaki M Gray A Ball C Lamb SE Nanchahal J

Aims

To estimate the potential cost-effectiveness of adalimumab compared with standard care alone for the treatment of early-stage Dupuytren’s disease (DD) and the value of further research from an NHS perspective.

Methods

We used data from the Repurposing anti-TNF for Dupuytren’s disease (RIDD) randomized controlled trial of intranodular adalimumab injections in patients with early-stage progressive DD. RIDD found that intranodular adalimumab injections reduced nodule hardness and size in patients with early-stage DD, indicating the potential to control disease progression. A within-trial cost-utility analysis compared four adalimumab injections with no further treatment against standard care alone, taking a 12-month time horizon and using prospective data on EuroQol five-dimension five-level questionnaire (EQ-5D-5L) and resource use from the RIDD trial. We also developed a patient-level simulation model similar to a Markov model to extrapolate trial outcomes over a lifetime using data from the RIDD trial and a literature review. This also evaluated repeated courses of adalimumab each time the nodule reactivated (every three years) in patients who initially responded.


Aims

The primary objective of this study was to compare the five-year tibial component migration and wear between highly crosslinked polyethylene (HXLPE) inserts and conventional polyethylene (PE) inserts of the uncemented Triathlon fixed insert cruciate-retaining total knee arthroplasty (TKA). Secondary objectives included clinical outcomes and patient-reported outcome measures (PROMs).

Methods

A double-blinded, randomized study was conducted including 96 TKAs. Tibial component migration and insert wear were measured with radiostereometric analysis (RSA) at three, six, 12, 24, and 60 months postoperatively. PROMS were collected preoperatively and at all follow-up timepoints.


The Bone & Joint Journal
Vol. 106-B, Issue 4 | Pages 324 - 335
1 Apr 2024
Fontalis A Kayani B Plastow R Giebaly DE Tahmassebi J Haddad IC Chambers A Mancino F Konan S Haddad FS

Aims

Achieving accurate implant positioning and restoring native hip biomechanics are key surgeon-controlled technical objectives in total hip arthroplasty (THA). The primary objective of this study was to compare the reproducibility of the planned preoperative centre of hip rotation (COR) in patients undergoing robotic arm-assisted THA versus conventional THA.

Methods

This prospective randomized controlled trial (RCT) included 60 patients with symptomatic hip osteoarthritis undergoing conventional THA (CO THA) versus robotic arm-assisted THA (RO THA). Patients in both arms underwent pre- and postoperative CT scans, and a patient-specific plan was created using the robotic software. The COR, combined offset, acetabular orientation, and leg length discrepancy were measured on the pre- and postoperative CT scanogram at six weeks following surgery.


Bone & Joint Open
Vol. 5, Issue 4 | Pages 343 - 349
22 Apr 2024
Franssen M Achten J Appelbe D Costa ML Dutton S Mason J Gould J Gray A Rangan A Sheehan W Singh H Gwilym SE

Aims

Fractures of the humeral shaft represent 3% to 5% of all fractures. The most common treatment for isolated humeral diaphysis fractures in the UK is non-operative using functional bracing, which carries a low risk of complications, but is associated with a longer healing time and a greater risk of nonunion than surgery. There is an increasing trend to surgical treatment, which may lead to quicker functional recovery and lower rates of fracture nonunion than functional bracing. However, surgery carries inherent risk, including infection, bleeding, and nerve damage. The aim of this trial is to evaluate the clinical and cost-effectiveness of functional bracing compared to surgical fixation for the treatment of humeral shaft fractures.

Methods

The HUmeral SHaft (HUSH) fracture study is a multicentre, prospective randomized superiority trial of surgical versus non-surgical interventions for humeral shaft fractures in adult patients. Participants will be randomized to receive either functional bracing or surgery. With 334 participants, the trial will have 90% power to detect a clinically important difference for the Disabilities of the Arm, Shoulder and Hand questionnaire score, assuming 20% loss to follow-up. Secondary outcomes will include function, pain, quality of life, complications, cost-effectiveness, time off work, and ability to drive.


Bone & Joint Open
Vol. 5, Issue 5 | Pages 411 - 418
20 May 2024
Schneider P Bajammal S Leighton R Witges K Rondeau K Duffy P

Aims

Isolated fractures of the ulnar diaphysis are uncommon, occurring at a rate of 0.02 to 0.04 per 1,000 cases. Despite their infrequency, these fractures commonly give rise to complications, such as nonunion, limited forearm pronation and supination, restricted elbow range of motion, radioulnar synostosis, and prolonged pain. Treatment options for this injury remain a topic of debate, with limited research available and no consensus on the optimal approach. Therefore, this trial aims to compare clinical, radiological, and functional outcomes of two treatment methods: open reduction and internal fixation (ORIF) versus nonoperative treatment in patients with isolated ulnar diaphyseal fractures.

Methods

This will be a multicentre, open-label, parallel randomized clinical trial (under National Clinical Trial number NCT01123447), accompanied by a parallel prospective cohort group for patients who meet the inclusion criteria, but decline randomization. Eligible patients will be randomized to one of the two treatment groups: 1) nonoperative treatment with closed reduction and below-elbow casting; or 2) surgical treatment with ORIF utilizing a limited contact dynamic compression plate and screw construct. The primary outcome measured will be the Disabilities of the Arm, Shoulder and Hand questionnaire score at 12 months post-injury. Additionally, functional outcomes will be assessed using the 36-Item Short Form Health Survey and pain visual analogue scale, allowing for a comparison of outcomes between groups. Secondary outcome measures will encompass clinical outcomes such as range of motion and grip strength, radiological parameters including time to union, as well as economic outcomes assessed from enrolment to 12 months post-injury.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_IV | Pages 584 - 584
1 Oct 2010
Brookes-Fazakerley S Atkinson C Walker C
Full Access

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.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 236 - 236
1 Mar 2010
Casserley-Feeney S Bury G Daly L Hurley D
Full Access

Background & Purpose: This pragmatic randomised clinical trial (RCT) investigated differences in the clinical outcomes of physiotherapy for low back pain (LBP) delivered in

public hospital-based secondary care versus

private community-based primary care in Ireland.

Methods: Between March 2005 and May 2006, 160 consenting subjects [110F, 50M; mean age (SD) yrs: 41.28 (12.83)] were recruited, stratified (acute: < 3/12; chronic: > 3/12), and randomly allocated to public hospital (H) or private community (P) physiotherapy. Subjects completed clinical outcomes (Roland Morris Disability Questionnaire (RMDQ). SF-36, Fear Avoidance Beliefs & Back Beliefs Questionnaires) at baseline, 3, 6 and 12 months post randomisation and the Patient Satisfaction with Outpatient Physical Therapy (PTOPS) survey at the end of treatment. Intention-to-treat analysis was conducted using the Statistical Package for the Social Sciences (SPSS, Version 12).

Results: There were no significant differences between groups at baseline (p> 0.05). Patient response rates were 85% (n=137), 80% (n=128) and 74% (n=118) at 3, 6, and 12 months. Despite significantly longer waiting times for public hospital physiotherapy, repeated measures ANOVA found no significant differences over time between groups for any of the outcome measures (p> 0.05), except ‘patient satisfaction with outcome,’ which was significantly higher in the P group (median difference: 0.00; p=0.020, Mann Whitney U=1324.50).

Conclusions & Implications: The trial cannot recommend one physiotherapy setting over the other for LBP management. However, the limited adherence to LBP clinical guidelines in both settings and the lack of improvement in psychosocial outcomes in subjects managed in both settings warrant further investigation.

Acknowledgements: Physiotherapists, General practitioners and patients in both settings.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 195 - 195
1 Mar 2010
Harato K Bourne R Hart J Victor J Snyder M Ries M
Full Access

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