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Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_I | Pages 14 - 14
1 Mar 2009
Kapoor A Rafiq I Harvey P Murali R
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INTRODUCTION: CTS is the most common nerve entrapment syndrome. Repeated flexion and extension activities of the wrist coupled with certain finger flexion causes oedema and compression of the median nerve within the carpal tunnel of the wrist. Several treatment options, both conservative and surgical are available to relieve the pressure on the median nerve. Although studies support the efficacy of splinting for CTS the length of splinting, type of splints, day or night use and the effects on other variables are still less agreed. MATERIALS AND METHODS: A Randomised control trial with subjects randomised to a splint and a control group. 44 patients(60 hands) evaluated at recruitment, 2,8 and 12 weeks. Difference in Levine’s symptom and functional severity scores, between the two groups, used as the primary outcome measure. STATISTICAL METHODS: Repeated measure analysis(ANOVA) and paired t test used for statistical analysis between the two groups. RESULTS: There was no difference between the two groups at baseline. Improvement in symptom severity score in the splinted group at the end of 12 weeks(p< 0.05). No difference in functional severity between the two groups. CONCLUSION: Splintage helps to improve symptoms related to carpal tunnel syndrome in a short term period. This is the duration that the patients referred by GP’s have to wait before seeing a hand specialist. Hence they can be treated with splints during this period to give them symptomatic relief


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XLI | Pages 117 - 117
1 Sep 2012
Gupta A Cooke C Wilkinson M Grazette A
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Prospective Randomised Control trial of 300 patients over a period of 3 years, 1 year post op follow up. Local ethic approval was attained for the study. Inclusion criteria: Age > 60, Consented to Participate in the study, Unstable Inter trochanteric fracture a) Sub trochanteric b) Medial Comminution c) Reverse Obliquity D)Severe Osteoporosis. Patients selected were randomized to Intra medullary Nail vs Hips screw. Variety of markers have been assessed: Pre OP: - Mechanism of injury, Mobility status, Pre OP ASA, Pre Op haemoglobin, living Conditions. Intra OP:- I.I Time, Time taken, Surgeon experience, Intra OP complications. Post OP:- Haemoglobin, mobility, radiographic analysis-Fracture stability and Tip Apex Distance, Thrombo embolic Complications. Follow up: - 6 weeks, 3,6,12 month follow up. There is considerable debate in literature regarding superiority of Compression Hip screw over Intra medullary nail for fixation of stable per trochanteric fractures of the femur. Biomechanical studies have shown superiority of Intra medullary device over a Compression Hip screw. Tenser et all showed an advantage over combined bending and compression failure. Mohammad et al found unstable subtrochanteric fractures with a gamma nail were stiffer. Kerush-Brinker showed that gamma nail had significantly greater fatigue strength and fatigue life. In unstable fractures Baumgartner et al found less intra op complications and less fluoroscopic time for a compression hip screw compared to a short intra medullary nail. There have been significant reports of fracture at the Tip of a short intra medullary nail. We think this complication can be avoided by using a long intra medullary device. Both in Australia and abroad the choice of which device to use depends largely on the preference of the surgeon


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_20 | Pages 93 - 93
1 Nov 2016
Weeks C Somerville L Phillips J Ganapathy S Howard J
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The use of spinal anesthesia with adjuvant intra-thecal opioids has been commonly used in total knee arthroplasty without documented clinical benefit. It has been associated with a potential increase in side effects, including nausea, vomiting, pruritus, urinary retention and oxygen usage. This double-blinded RCT investigated whether the addition of epimorph to spinal anesthesia in patients undergoing total knee arthroplasty resulted in superior pain control and decreased narcotic consumption without also causing an increase in postoperative complication rates.

We performed a prospective double-blind trial in patients undergoing primary total knee arthroplasty (TKA). Patients were randomised to receive either spinal anesthesia alone or spinal anesthesia with epimorph (150 ug). All patients received infiltration of a local anesthetic cocktail intraoperatively. Both the study patients and staff measuring outcomes were blinded to the experimental treatment received during data collection. Postoperatively, visual analogue scale (VAS) for pain was recorded at 6, 12, 18, 24, 36 and 48hrs and a final value at 1 week. Narcotic use, Foley insertion, oxygen requirements, nausea, vomiting and pruritus were recorded during the course of hospitalisation.

Forty-one patients were randomised into each of the spinal with epimorph and spinal alone treatment arms. The groups showed no significant differences in BMI, age, and gender distribution. In the first 12 hours postoperatively there was no difference in VAS for pain between the two groups, however there were significantly lower pain scores in the spinal alone patients at 18 hours (p=0.002), 24 hours (p=0.04) and 48 hours (p = 0.03) compared to the spinal with epimorph group. Narcotic usage was greater in the spinal group during the first 6 hours postoperatively, but beyond this time point narcotic usage was similar between the two groups. Additionally, there was a statistically significant increase in rate of complications with spinal epimorph including nausea (p=0.037) and pruritus (p=0.024). The incidence of urinary retention was greater in the spinal epimorph group, however this did not reach statistical significance.

This study demonstrates no clinical benefit with the addition of intra-thecal opioids to spinal anesthetic in primary TKA. In addition to a failing to reduce VAS pain scores and overall narcotic consumption, increased complication rates were seen. For these reasons, this study does not support the use of epimorph in addition to spinal anesthesia for pain control in TKA.


The Journal of Bone & Joint Surgery British Volume
Vol. 88-B, Issue 1 | Pages 69 - 77
1 Jan 2006
Costa ML MacMillan K Halliday D Chester R Shepstone L Robinson AHN Donell ST

We performed two independent, randomised, controlled trials in order to assess the potential benefits of immediate weight-bearing mobilisation after rupture of the tendo Achillis. The first trial, on operatively-treated patients showed an improved functional outcome for patients mobilised fully weight-bearing after surgical repair. Two cases of re-rupture in the treatment group suggested that careful patient selection is required as patients need to follow a structured rehabilitation regimen. The second trial, on conservatively-treated patients, provided no evidence of a functional benefit from immediate weight-bearing mobilisation. However, the practical advantages of immediate weight-bearing did not predispose the patients to a higher complication rate. In particular, there was no evidence of tendon lengthening or a higher re-rupture rate. We would advocate immediate weight-bearing mobilisation for the rehabilitation of all patients with rupture of the tendo Achillis.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_IV | Pages 87 - 87
1 Mar 2012
Goel V Dabke H Gajjar S Jones A Kulkarni R
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Aims

To assess the accuracy of posterior and anterolateral methods of injection into the subacromial space (SAS) of the shoulder.

Patients and methods

Ethical approval was obtained and 50 patients (23 women and 27 men) with mean age of 64.5 years (42-87 years) and clinical diagnosis of subacromial impingement were recruited. Patients with old or recent shoulder fracture, bleeding disorders, and allergy to iodine were excluded. All injections were given by the consultant or an experienced registrar after obtaining informed consent. Patients were randomised into posterior and anterolateral groups and the method of injection was revealed by opening sealed envelopes just before the injection. A combination of 3mls 0.5% bupivacaine and 2mls of radiographic dye (Niopam) was injected in the subacromial space (SAS) using either anterolateral (n-22) and posterior approaches (28).

AP and lateral radiographs of shoulder were taken after injection and were reported by a Consultant Radiologist blinded to the method of injection. Visual analogue scale (VAS) and Constant-Murley shoulder score was used to assess pain and function respectively. Both scores were determined before and 30 minutes after the injection.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_III | Pages 375 - 375
1 Jul 2011
Lamberton T Poutawera V
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Knee flexion is often decreased in severe arthritis causing pain, and functional limitations in lifestyles and occupations. Newer knee replacement designs offer the possibility of greater knee motion. The objective of our study was to compare the clinical outcomes, in particular the range of motion, in patients treated with a total knee arthroplasty using either a standard posterior stabilized knee prosthesis or a high flexion posterior stabilized knee prosthesis, with regard to return to function within 1 year of surgery.

This was a prospective randomized single blinded study. Forty patients were randomly assigned to receive either a standard fixed bearing posterior stabilized or a modified high flexion fixed bearing posterior stabilized Smith & Nephew Genesis II total knee joint replacement. Clinical outcomes were determined from data collected on all patients who were evaluated pre-operatively, at twelve weeks post-operatively, and at one year post-operatively. Data collected included SF-12, WOMAC, and Oxford knee scores, and knee range of motion measurements.

37 of 40 patients enrolled completed the study. 22 patients were randomized to receive a standard posterior stabilized fixed bearing Genesis II knee replacement and 22 were randomized to receive a Hi-Flex posterior stabilized fixed bearing knee replacement. ROM, quality of life, and clinical scores at 12 months will be presented.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_5 | Pages 3 - 3
1 Feb 2013
Robinson CM Goudie EB Murray IR Akhtar A Jenkins P Read E Foster C Brooksbank A Arthur A Chesser T
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This multi-centre single-blind randomised control trial compared outcomes in patients with acute displaced mid-shaft clavicle fractures treated either by primary open reduction and plate fixation (ORPF), or non-operative treatment (NT).

Two-hundred patients were randomised to receive either ORPF or NT. Functional assessment was conducted up to one-year using DASH, SF-12 and Constant scores (CS). Union was evaluated using radiographs and CT.

Rate of non-union was significantly reduced after ORPF (1 following ORPF, 16 following NT, odds ratio=0.07, 95% CI=0.01–0.50, p=0.0006). 7 patients had delayed-union after NT. Group allocation to ORPF was independently predictive of development of non-union. DASH and CS were significantly better in the ORPF group 3-months post-surgery, but not at one-year (mean DASH = 6.2 after NT versus 3.7 after ORPF, p=0.09; mean CS = 86.1 after NT versus 90.7 after ORPF, p=0.05). Group allocation was not predictive of one-year outcome. Non-union was the only factor independently predictive of one-year functional outcome. There were no significant differences in time off work or subjective scores. Five patients underwent revision for complications after ORPF. 10 patients underwent metalwork removal. Treatment cost was significantly greater after ORPF (p=0.001). ORPF reduces rate of non-union compared with NT and is associated with better early functional outcomes. Improved outcomes are not sustained at one-year. Differences in functional outcome appear to be mediated by prevention of non-union from ORPF. ORPF is more expensive and associated with implant-related complications not seen with NT. Our results do not support routine primary ORPF for displaced mid-shaft clavicle fractures.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVIII | Pages 185 - 185
1 Sep 2012
Slobogean GP Marra C Sanders DW
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Purpose

A recent multicentre randomized control trial (RCT) failed to demonstrate superior quality of life at one year following open reduction and internal fixation (ORIF) compared to nonoperative treatment for unstable isolated fibular fractures. We sought to determine the cost-effectiveness of ORIF compared to non-operative management of unstable fibular fractures.

Method

A decision tree was used to model the results of a multicentre trial comparing ORIF versus nonoperative treatment for isolated fibular fractures. A single payer, governmental perspective was used for the analysis. Utilities (a measure of preference for a health state) were obtained from the subjects Short-Form-6D scores and used to calculated Quality Adjusted Life Years (QALYs). Probabilities for each strategy were taken from the one-year trial endpoint. Costs were obtained from the Ontario Case Costing Initiative. Sensitivity analysis was performed for all model variables to determine when ORIF is a cost-effective treatment (incremental cost per QALY gained < $75,000).


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. 94-B, Issue SUPP_XVII | Pages 38 - 38
1 May 2012
Bruce-Brand R O'Byrne J Moyna N
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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.

Twenty-eight patients, aged fifty-five to seventy-five, were recruited and randomised to either a six-week home resistance-training exercise program or a six-week neuromuscular electrical stimulation (NMES) program. 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 for twenty minutes five times per week Outcome measures included isometric and isokinetic quadriceps strength, functional capacity, quadriceps cross-sectional area, and validated health survey scores. These measures were assessed at baseline, post-intervention and at 6-weeks post-intervention.

Both intervention groups showed significant improvements in all functional tests, in the global health survey, and in quadriceps cross-sectional area immediately post-intervention. An increase in isokinetic strength was seen in the exercise group only. With the exception of isokinetic strength, all benefits were maintained six weeks post-intervention.

Both a six-week home resistance-training program and a six-week NMES program produce 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, and is especially appropriate for patients who have difficulty complying with an exercise program.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXI | Pages 109 - 109
1 May 2012
M. R K. M D. JE H. DA P. AB
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Introduction

Despite evidence of long term survival of cemented femoral stem prostheses, studies have shown concerns in the longevity of the cemented sockets. This has led to a rise in the use of uncemented and hybrid implants (with uncemented cup and cemented stem) without long term studies to determine evidence for their use. We aimed to assess whether there is any difference in clinical outcome between cemented and non-cemented acetabular fixation in elderly patients.

Patients and Methods

Between February 2001 and August 2006 186 patients over 72 years of age were prospectively randomised to receive either a cemented Exeter cup or a HA coated press fit cementless cup. Both groups received a cemented Exeter stem. The patients were assessed pre-operatively and reviewed at 6 weeks, 6 months and yearly in a research clinic, by an independent observer. Outcome measures were the Merle D'Aubigné, Postel, Oxford Hip and Visual analogue pain scores. The implants were also assessed radiographically and all complications were recorded.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_14 | Pages 18 - 18
1 Jul 2016
Roberts V Attwall M Fombon F Bhatia M
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Osseous first ray surgery is a common day case procedure. Patients are often given regional blocks. We sought to find if there is a difference between ankle block and metatarsal block in this group of patients. After ethical approval was granted and power analysis performed, 25 patients were recruited into each arm of the study. These patients were having either an osteotomy or arthrodesis.

All patients had standardised general anaesthesia and received 20mls of 0.5% chirocaine for the blockade. The cohort having the ankle block had infiltration under ultrasound guidance in the anaesthetic room; and the cohort receiving the metatarsal block had infiltration at the end of the procedure. The timings of both the anaesthesia and the operation were recorded for each patient.

Patients scored their pain level at 2, 6 and 24 hours. The amount of post-operative analgesia used in the first 24 hours was also recorded by the research nurse. All patients were discharged home with a standardised prescription of analgesia.

Analysis of the pain scores showed that there was no difference between the two blocks at any measured time period. Nor was there a difference in the analgesic requirement in the first 24 hours. There was, however, a difference in the time taken for the whole procedure: with the ankle block taking an average of ten minutes more.

We conclude that metatarsal blocks are as effective as ankle blocks in providing pain relief after osseous first ray surgery, and may be a more efficient use of time.


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_I | Pages 2 - 2
1 Jan 2004
Mofidi A
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Absorbable cement restrictors have been in use over the last few years. They have been shown to be as effective as the standard non-absorbable cement restrictors in achieving cement pressurisation and stopping distal cement migration in in vitro studies. The aim of this study is to compare in vivo, the effectiveness of absorbable with non-absorbable cement restrictors.

One hundred and thirty-six consecutive patients who had total hip replacement performed using charnley cemented femoral prosthesis were selected and randomly divided in to two groups pre operatively. One group received Hardinge TM non-absorbable cement restrictor and the second group received Biostop TM absorbable cement restrictor. Type of the prosthesis, the surgical approach, the time from start of mixing of the cement to insertion of the cement (measure of viscosity of the cement), the cementing technique and the distance at which the cement restrictor was inserted were noted intraoperatively, the canal diameter was measured from the preoperative AP radiograph of the hip. The distance at which the cement restrictor was inserted was measured on the AP radiograph of the hip taken twenty-four hours postoperatively. All the above factors were statistically assessed as to their effect in the distal migration on cement restrictor using multiple regression analysis.

There was no statistical difference between the two types of cement restrictors (P= 0.44). Surgeon, Surgical approach, femoral canal diameter P> 0.2 cementing technique P> 0.1 and Cement viscosity P= 0.082 had no effect on the degree of distal migration of the cement.

In conclusion Biostop TM absorbable cement restrictor is as effective as Hardinge TM non-absorbable cement restrictor. We could not show any relationship between femoral canal diameter cementing technique and cement viscosity and distal cement migration which leads us to conclude that in the presence of adequate cement restriction these factors have little effect in distal migration of cement mantle.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_4 | Pages 22 - 22
1 Feb 2014
Patel S Hee S Yang Y Ngunjiri A Brown S Friede T Griffiths F Lord J Sandhu H Thistlethwaite J Tysall C Woolvine M Underwood M
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Background

The available treatments for NSLBP (Non-Specific Low Back Pain) provide, typically, small to moderate average benefits to patients. The aim of this pilot cluster RCT was to test the hypothesis that the use of a patient decision aid together with an informed shared decision making consultation would produce better outcomes in satisfaction with treatment at four month follow-up.

Methods

We developed a DSP (Decision Support Package). We randomised the physiotherapists and trained those in the intervention arm in informed shared decision making and communication. Participants were recruited from a local physiotherapy department and those allocated to an appointment with an intervention therapist were sent a copy of the DSP in the post. Participants then attended their appointment as usual.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 254 - 255
1 May 2009
Goel D Abelseth G Buckley R deVries G Fick G Gray R Ni A
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The incidence of DVT and need for thrombo-prophylaxis following isolated distal lower extremity fractures is unknown. The purpose of this study was to determine whether or not thrombo-prophylaxis with low molecular weight heparin was needed in this trauma population.

A Multicentered Prospective Randomised Double Blind Placebo Controlled Trial was designed to define the incidence of DVT and need for thrombo-prophylaxis in this population. A sample size of two hundred and ninety-nine patients ensured a one tailed type one error of alpha = 0.05 and power of 80% as confirmed from previous studies. Males and female patients between the ages of eighteen and seventy-five years with isolated distal lower extremity fractures (excluding the foot) were eligible. All patients had surgery within forty-eight hours after injury. Patients excluded from the trial were polytrauma patients, those medically unfit for the operating room, patients with foot fractures, those receiving anticoagulation, inability to provide consent, platelets 200 umol /L. Randomization was carried out via computer generation to receive either placebo or Fragmin for fourteen days. At fourteen days, all patients underwent bilateral venograms interpreted by three independent radiologists. Equivocal venograms were interpreted by consensus. Routine follow-up was carried out for all patients at two, six, eight and twelve weeks.

A total of two hundred and ninety-nine patients were enrolled in the study. One hundred thirty-six patients in the Fragmin group and one hundred and twentyfive in the placebo group completed the intervention. There were one hundred and twenty-five males and one hundred and thirty-six females in total. There was no statistically significant difference in DVT incidence between those patients treated with Fragmin or Placebo (p = 0.41). Gender, medical issues, pre-operative level of activity and body mass index had no effect on the incidence of DVT.

The incidence of DVT in fragmin treated and placebo treated patients is 8.1% and 11.2%, respectively (p = 0.41). This study suggests that DVT thrombo-prophylaxis is not indicated in this patient population. To our knowledge, this is the first Randomised Controlled Trial utilizing venograms (gold standard) for DVT identification.


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_4 | Pages 11 - 11
1 May 2015
Clement N Keenan G Marsh D Nayagam D Atkins R Simpson A
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We conducted a multicentre two arm double blind randomised controlled trial to assess efficacy of pulsed ultrasound for accelerating the rate of bone healing. Sixty-two skeletally mature adults undergoing limb lengthening, of between 2.5cm to 10cm by distraction osteogenesis, at the proximal tibia using an Ilizarov frame were randomised to either an active or a placebo (control) ultrasound device.

Primary outcome measure was time ready for removal of frame after adjusting for distraction length (days/cm) for both intension to treat (ITT) and per protocol (PP) patients. The time at which the frame was removed was determined by the maturation of the regenerate bone. Secondary outcomes were return to weight bearing and covariates affecting time to frame removal.

The baseline characteristics of the two groups were well balanced, and 90% of patients were managed and followed up as PP. There was no difference in the time to frame removal between the two groups for the ITT (5.0days/cm, p=0.23) or the PP (10.1days/cm, p=0.054). There was no difference in return to weight bearing between the two groups, after adjusting for distraction length, for the ITT or PP patients (p>0.5). Smoking was the only covariate identified to increase the frame removal time (hazard ratio 0.46, 95% confidence interval 0.22 to 0.96; p=0.04).

This trial demonstrated no difference in bone healing between those who underwent pulsed ultrasound and those who did not. Smoking was observed to have a significant inhibitory effect on bone healing.


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_5 | Pages 11 - 11
1 May 2015
Simpson A Clement N Keenan G Nayagam S Atkins R Marsh D
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Objective:

To assess efficacy of pulsed ultrasound for accelerating regenerate consolidation.

Design:

A multicentre two arm patient and assessor double blind RCT


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVIII | Pages 152 - 152
1 Sep 2012
Lapner P Bell K Sabri E Rakhra K McRae S Leiter J MacDonald PB
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Purpose

Controversy exists regarding the optimal technique for arthroscopic rotator cuff repair. The purpose of this multicentre randomized double-blind controlled study was to compare the functional outcomes and healing rates of double-row suture techniques with single row repair.

Method

Patients undergoing arthroscopic rotator cuff repair were randomized to receive either a double row (DR) or single row (SR) repair. The primary objective was to compare the WORC score at 24 months. Secondary objectives included anatomical outcomes by MRI or ultrasound, the Constant, and ASES scores. A sample size calculation determined that 84 patients provided 80% power with a 50% effect size to detect a statistical difference between groups.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_I | Pages 46 - 46
1 Jan 2011
Sivaprakasam M Chana R Divekar A Dunnet W Zahn H
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Aim: The aim of this study is to analyse the peri-operative complications of the Bimetric femoral hip prosthesis (Biomet UK Ltd) and to evaluate the osteo-conductive and osteo-inductive performance of HA coatings in this implant.

Materials and Methods: This is an ongoing randomised control study (retrieval) over a period of 4 years at William Harvey Hospital, Ashford, Kent. Three types of HA coatings were used – plasma sprayed HAC 60μm, bonemaster dense HAC 3μm, bonemaster graded HAC 7μm. Three retrieved implants were sent for histological examination at The Royal National Orthopaedic Hospital, Stanmore.

Results: Fifty Four patients with mean age of 77 years (66–89) were evaluated. There were 12 (22%) surgical complications- 9 (7.4%) periprosthetic fractures, 2 stems subsided, 1 stem cemented. There was 5.5 % (3/54) risk of revision in 4 years (p< 0.001). The histological photomicrograph with the three different coatings examined showed Bone master 3–7μm coating had excellent bony in growth (osteo-integration).

Conclusion: In our series there was 5.5% risk of revision rate. The periprosthetic fracture and early mortality rates are within national limits. Revision surgery is the most significant aspect and this should be our primary concern. Hydroxyapatite coated stems with newer technique coating promotes good osteo-integration.


The Journal of Bone & Joint Surgery British Volume
Vol. 92-B, Issue 7 | Pages 935 - 940
1 Jul 2010
McCalden RW Charron KD Yuan X Bourne RB Naudie DD MacDonald SJ

This was a safety study where the hypothesis was that the newer-design CPCS femoral stem would demonstrate similar early clinical results and micromovement to the well-established Exeter stem. Both are collarless, tapered, polished cemented stems, the only difference being a slight lateral to medial taper with the CPCS stem. A total of 34 patients were enrolled in a single-blinded randomised controlled trial in which 17 patients received a dedicated radiostereometric CPCS stem and 17 a radiostereometric Exeter stem. No difference was found in any of the outcome measures pre-operatively or post-operatively between groups. At two years, the mean subsidence for the CPCS stem was nearly half that seen for the Exeter stem (0.77 mm (−0.943 to 1.77) and 1.25 mm (0.719 to 1.625), respectively; p = 0.032). In contrast, the mean internal rotation of the CPCS stem was approximately twice that of the Exeter (1.61° (−1.07° to 4.33°) and 0.59° (0.97° to 1.64°), respectively; p = 0.048). Other migration patterns were not significantly different between the stems. The subtle differences in designs may explain the different patterns of migration.

Comparable migration with the Exeter stem suggests that the CPCS design will perform well in the long term.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXII | Pages 59 - 59
1 May 2012
Paringe V Vannet N Ferran N Gandour A
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ECSWT has been on the medical horizon for last 30 years mainly in urology for urolithiasis and has found a parallel use in orthopaedics for various chronic soft tissue conditions like Tendoachilles tendinoses and plantar fasciitis etc. ECSWT acts a piezoelectric device releasing acoustic energy and causing micro-trauma activating cytokine mediated response stimulating local angiogenesis and tissue repair.

Methodology

56 patients were recruited for the trial after ethics approval was achieved. The diagnosis was confirmed with ultrasound scan and measuring the width of the swelling and the local hypervascularity. The cohort of the patients was randomised in groups for physiotherapy [n=23] and shockwave therapy [n= 23]. The patient groups with shockwave therapy received a 3-week treatment with typical 2000 impulses per session once a week and physiotherapy group was subjected to eccentric loading exercises. Patients were assessed at 12 week with AOFAS, VISA-A scores and repeat ultrasound scan.

Results

The average age of the average age was 51 years [36- 73 years] Mean duration of symptoms prior to treatment was 25 months (range 6-60 months). AOFAS scores increased in both groups: from 64□86 in the ECSWT group and 72□79 in the physiotherapy group. VISA-A scores also increased in both groups from 39□73 in the ECSWT group and from 36□56 in the physiotherapy group. Scores were significantly higher in the ECWST group post treatment. The ultrasound scan findings suggested the tendon girth receding from 10.9 mm□9.9 mm in physiotherapy group while 9.8 mm□8.7 mm in the ECSWT group with hypervascularity decreasing from marked to mild in both groups. Statistical significance was established using SPSS 16 p < 0.001in post treatment group.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XLI | Pages 154 - 154
1 Sep 2012
Harvie P Sloan K Beaver R
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We previously compared component alignment in total knee replacement using a computer-navigated technique with a conventional jig based method. Improved alignment was seen in the computer-navigated group (Beaver et al. JBJS 2004 (86B); 3: 372–7.). We also reported two-year results showing no difference in clinical outcome between the two groups (Beaver et al. JBJS 2007 (89B); 4: 477–80). We now report our five-year functional results comparing navigated and conventional total knee replacement. To our knowlege this represents the first Level 1 study comparing function in navigated and conventional total knee replacement at five years.

An original cohort of 71 patients undergoing Duracon (Stryker Orthopaedics, St. Leonards, Australia) total knee replacement without patellar resurfacing were prospectively randomised to undergo operation using computer navigation (Stryker Image Free Computer Navigation System (version 1.0; Stryker Orthopaedics))(n=35) or a jig-based method (n=36). The two groups were matched for age, gender, height, weight, BMI, ASA grade and pre-operative deformity. All operations were performed by a single surgeon. All patients underwent review in our Joint Replacement Assessment Clinic at 3, 6 and 12 months and at 2 and 5 years. Reviews were undertaken by senior physiotherapist blinded to participant status using validated outcome scoring tools (Knee Society Score, WOMAC Score and Short Form SF-36 Score). All patients underwent CT scanning of the implanted prosthesis as per Perth CT Knee Protocol to assess component alignment.

After 5 years 24 patients in the navigated group and 22 patients in the conventional group were available for review. At 5 years no statistically significant difference was seen in any of the aforementioned outcome scores when comparing navigated and conventional groups. No statistically significant difference was seen between 2- and 5-year results for either group.

Due to the relatively low numbers in each group these data were compared with retrospective cohorts of navigated (n=100) and conventional (n=70) Duracon total knee replacements performed outwith this study over the same 5-year period. WITHIN the retrospective cohorts no statistically significant differences were found when comparing any of the aforementioned outcome scores. In addition, when comparing parallel scores between prospective and retrospective groups again no statistically significant differences were identified.

At 5-years post-operatively the functional outcome between computer navigated and conventional total knee replacement appears to be no different despite the better alignment achieved using navigation.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_II | Pages 93 - 93
1 May 2011
Beaver R Sloan K Harvie P
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Introduction: We previously compared component alignment in total knee replacement using a computer-navigated technique with a conventional jig based method. Improved alignment was seen in the computer-navigated group (Beaver et al. JBJS 2004 (86B); 3: 372–7.). We also reported two-year results showing no difference in clinical outcome between the two groups (Beaver et al. JBJS 2007 (89B); 4: 477–80). We now report our five-year functional results comparing navigated and conventional total knee replacement. To our knowlege this represents the first Level 1 study comparing function in navigated and conventional total knee replacement at five years.

Methods: An original cohort of 71 patients undergoing Duracon (Stryker Orthopaedics, St. Leonards, Australia) total knee replacement without patellar resurfacing were prospectively randomised to undergo operation using computer navigation (Stryker Image Free Computer Navigation System (version 1.0; Stryker Orthopaedics))(n=35) or a jig-based method (n=36). The two groups were matched for age, gender, height, weight, BMI, ASA grade and pre-operative deformity. All operations were performed by a single surgeon. All patients underwent review in our Joint Replacement Assessment Clinic at 3, 6 and 12 months and at 2 and 5 years. Reviews were undertaken by senior physiotherpist blinded to participant status using validated outcome scoring tools (Knee Society Score, WOMAC Score and Short Form SF-36 Score). All patients underwent CT scanning of the implanted prosthesis as per Perth CT Knee Protocol to assess component alignment.

Results: After 5 years 24 patients in the navigated group and 22 patients in the conventional group were available for review. At 5 years no statistically significant difference was seen in any of the aforementioned outcome scores when comparing navigated and conventional groups. No statistically significant difference was seen between 2- and 5-year results for either group.

Due to the relatively low numbers in each group these data were compared with retrospective cohorts of navigated (n=100) and conventional (n=70) Duracon total knee replacements performed outwith this study over the same 5-year period. WITHIN the retrospective cohorts no statistically significant differences were found when comparing any of the aforementioned outcome scores. In addition, when comparing parallel scores between prospective and retrospective groups again no statistically significant differences were identified.

Conclusion: At 5-years post-operatively the functional outcome between computer navigated and conventional total knee replacement appears to be no different despite the better alignment achieved using navigation.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_III | Pages 405 - 405
1 Sep 2009
Farr D Conn K Britton J Calder J Stranks G
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Method: This study reports upon 216 patients (97 Minimally invasive and 119 Standard) enrolled into a randomised control trial comparing a standard posterior approach to the hip with a single incision minimally invasive surgery (MIS) posterior approach at 6 weeks and 1 year post-operatively. Primary outcome measures included operative time, blood loss, length of stay and functional hip scores.

Results: The demographics and pre-operative hip scores for both cohorts were statistically similar. Intra-operative blood loss was significantly reduced in the MIS cohort (p=< 0.01). There was no difference in surgical time (p=0.37), time to discharge (p=0.24) or complication rate between the two groups.

Both groups had statistically improved post-operative hip scores, however, at the 1 year follow-up the MIS group were significantly better in terms of WOMAC, Harris Hip, Merle d’Aubigne and SF-12 scores when compared with a standard posterior approach.

Conclusion: This study demonstrates that MIS THA is a safe, reproducible technique in a DGH. We recommend the use of MIS techniques in primary THA and adhere to the principle that an incision need be no longer than necessary to perform the procedure safely.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_IV | Pages 1 - 1
1 Mar 2012
Bahari S Dahab ME Cleary M Sparkes J
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Introduction

This study was performed to investigate the efficacy of steroid and local anaesthesia (LA) in reducing post-operative pain in lumbar discectomy.

Materials and methods

The study was ethically approved. Patients undergoing primary single level lumbar discectomy were randomised by a closed envelope system into 4 groups, which were (Group 1) 10mg of adcortyl in 1ml and 1ml of 0.5% marcaine, (Group 2) 10mg of adcortyl and 1ml of normal saline, (Group 3) 1ml of 0.5% marcaine and 1ml of normal saline and (Group 4) 2mls of normal saline as control. Combinations of the above were applied topically over the nerve root prior to closure. Pre-operative, day 1 and eight weeks post-operative pain scores were recorded. 24 hours post-operative opiate analgesia requirements and duration of inpatient stay were recorded. Data were analysed using student t-test for statistical significance.


Background: The main aim of this study is to compare the difference between early mobilisation versus non weight bearing in patients post ankle fracture fixation in terms of pain and functional outcome

Methods: We recruited 60 patients and were divide into two equal groups. Patients in Group A were treated with a below knee cast post ankle fracture fixation and remained non weight bearing for six weeks while groub B were patients that were treated with a backslab for two weeks post fixation. The backslab was removed and once their radiographs were deemed satisfactory, They were referred to the physiotherapy service in our unit for range of motion exercises while still remaining non-weight bearing. All patients were allowed to weight bear at six weeks time post fixation. The inclusion criteria included patients within the age of 18 to 40 years of age and all the fractures are classified using the Weber classification. Patients that were excluded from theses studies are those with unstable fractures and have high co-morbid conditions. All these patients were followed up at 2 weeks, 6 weeks, 3 months and 9 months post ankle fracture fixation. Pain and functional outcome were scored using the AOFAS scoring system.

Results: We found that patients in both these groups scored almost equally during the 2 week follow up but at 6 week, group B showed much better range of movement with less pain and a much higher satisfaction rate with their range of movement. However, at 9 months, patients in both group were able to return to their normal physical activity.

Conclusion: Our conclusion is that early mobilisation has an definite advantage over non weight bearing post ankle fracture with regards to functional outcome, pain scoring and patient satisfaction. Patient selection and compliance play a role in the outcome of the study.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_I | Pages 69 - 69
1 Mar 2009
Bahari S El-Dahab M Cleary M Sparkes J
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Introduction: This study is performed to investigate the efficacy of steroid, local anaesthesia (LA) or combination of both in reducing post operative pain in lumbar discectomy.

Materials and Methods: The study was ethically approved. Patients undergoing primary single level lumbar discectomy were randomised by a closed envelope system into 4 groups of 1ml of steroid and 1ml of LA, 1ml of steroid and 1ml of saline, 1ml of LA and 1ml of saline and 2mls of saline as control. 10mg of adcortyl in 1ml and 1ml of 0.5% marcaine were used. Combinations of above were applied topically over the nerve root prior to closure. Preoperative, day 1 and eight weeks post operative visual analogue pain score were recorded. 10cm visual analogue pain score chart was used. 24 hours post operative opiate analgesia requirements and duration of inpatient stay were recorded. Data was analysed using Student t-test and Fisher exact t-test.

Results: No significant differences seen in the mean pre operative pain score between all groups. Mean Day 1 post operative pain and analgesia requirement in steroid and LA, steroid only, LA only and control group were 0.9, 2.5, 2.1 and 3.3 respectively. Mean opiate analgesia requirement 24 hours post operatively were 32.4mg, 54mg, 32.4mg and 56.8mg respectively. Mean inpatient stay were 2.2day, 3.91day, 4.62day and 3.63day respectively. At 8 weeks post operatively, no significant differences in the pain score in all groups.

Conclusions: Significant post operative pain reduction was achieved in the steroid and local anaesthesia group compared with other groups (p< 0.05). The results are reflected as well in significant reduction in the post operative analgesia requirement (p< 0.05) and the significant reduction in inpatient stay. (p< 0.05) We recommended the use of perioperative steroid and LA infiltration in lumbar discectomy. Improved post operative pain control reduces post operative opiate analgesia requirement and reduced inpatient stay.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XLI | Pages 116 - 116
1 Sep 2012
Barton T Chesser T Harries W Gleeson R Topliss C Greenwood R
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Controversy exists whether to treat unstable pertrochanteric hip fractures with either intra-medullary or extra-medullary devices. A prospective randomised control trial was performed to compare the outcome of unstable pertrochanteric hip fractures stabilised with either a sliding hip screw or long Gamma Nail. The hypothesis was that there is no difference in outcome between the two modes of treatment.

Over a four year period, 210 patients presenting with an unstable pertrochanteric hip fracture (AO/OTA 31 A2) were recruited into the study. Eligible patients were randomised on admission to either long Gamma Nail or sliding hip screw. Follow-up was arranged for three, six, and twelve months. Primary outcome measures were implant failure or ‘cut-out’. Secondary measures included mortality, length of hospital stay, transfusion rate, change in mobility and residence, and EuroQol outcome score.

Five patients required revision surgery for implant cut-out (2.5%), of which three were long Gamma Nails and two were sliding hip screws (no significant difference). There were no incidences of implant failure or deep infection. Tip apex distance was found to correlate with implant cut-out. There was no statistically significant difference in either the EuroQol outcome scores or mortality rates between the two groups when corrected for mini mental score. There was no difference in transfusion rates, length of hospital stay, and change in mobility or residence. There was a clear cost difference between the implants.

The sliding hip screw remains the gold standard in the treatment of unstable pertrochanteric fractures of the proximal femur.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 45 - 45
1 Mar 2006
Glyn-Jones S Gill R McLardy-Smith P Murray D
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Introduction Polyethylene wear debris is an important cause of failure in cemented total hip arthroplasty. As a result of the biological response to debris at the bone-cement interface, osteolysis and subsequent failure occurs in both femoral and acetabular components. Most acetabular components and liners are made of ultra high molecular weight polyethylene (UHMWPE). Cross-linking UHMWPE has been shown to significantly reduce abrasive wear in hip simulator studies. The wear rates measured in vitro do not always correlate with the wear rates measured in clinical studies[1]. Some new polyethylenes have shown catastrophic wear in clinical studies despite encouraging hip simulator study results[2]. The aim of this study was to compare the wear of standard UHMWPE to that of cross-linked UHMWPE (Longevity, Zimmer, Warsaw, USA)

Patients and Methods This was a prospective, double blind, randomised control trial. 50 subjects were recruited, all of whom received the cemented CPT stem and uncemented Trilogy liner (Zimmer, UK). Subjects were randomised to receive either a standard Trilogy liner or a Longevity liner at the time of operation. Both liners are identical in appearance. All liners were of a neutral configuration. RSA was used to measure linear wear. This was calculated by measuring the distance between the centre of the femoral head and the centre of the acetabular liner. The preliminary results of the study are presented.

Results Both groups underwent significant wear over two years. The two year linear wear of the cross-linked UHMWPE was 0.3mm (+/− 0.06mm, p< 0.001). The two year linear wear of the standard UHMWPE was 0.39mm (+/− 0.04mm, p< 0.001). No significant difference existed between the two groups (p=0.24). Both cohorts had around 0.15 to 0.2 mm of measured wear per year. Cross-linked UHMWPE therefore underwent less wear than standard UHMWPE at two years, however this difference was not statistically significant.

Discussion This study suggests that Longevity UHMWPE has similar wear properties to standard UHMWPE in the first two years following implantation. This does not correlate with in vitro hip simulator studies of Longevity polyethylene, which show a significantly lower wear rate than standard UHMWPE. It suggests that hip simulator studies may be of little value in predicting in vivo wear rates and that all new types of polyethylene should be evaluated clinically and radiologically prior to general release. Whether both cohorts continue to wear at similar rates will only be revealed through continued observation.


Introduction: Lumbar discectomy is now the operation of choice for lumbosacral radicular syndrome. Few studies of high quality have been performed on the post surgical management of these cases. The studies that have been reported compare one exercise regime to another.

The aim of this study was to compare long term outcomes of usual surgical advice, involving no formal post-surgical rehabilitation, with a non-aggravating six month gym rehabilitation programme post lumbar discectomy. This study is a prospective randomized controlled trial using a cohort followed for three years.

Methods: The patients were computer randomised into two groups. Group A, the control group followed usual surgical advice which was to resume normal activity as soon as pain allowed. Group B, undertook the gym rehabilitation programme. Inclusion criteria were: Age 17 to 65 years, good health and no major medical problems. The surgical level had to be L3, L4, or L5. Patients were excluded if they had central neurological disorders, communication difficulties, any condition making gym-based exercises unsafe, or if the surgery was indicated for spinal infection, tumour or inflammatory disease. Patients were followed for a three year period using validated outcome measures (Roland-Morris Questionnaire and Oswestry Low Back Pain Index) and an annual Quality of Life (QoL) questionnaire. A sample of 40 per group provided the study with 80% power (P< 0.05) to detect a 3.5 point change in the RMQ and a 10% change in the ODI. The annual questionnaire reported information on number of GP visits, other therapist visits, medication levels and time off work.

Results: Ninety three participants were randomised; Control n=46 and trial n=47. Eighty nine participants completed the study. Randomisation achieved a balance of confounding factors, with the exception of work heaviness, where there were a greater number of participants in the very heavy and heavy categories in the trial group (P< 0.01). Thirty nine of 47 participants completed the gym programme (83%). Functional outcome measures did not show statistically significant differences between groups over the three year period. Key findings of cumulative 3 year data for the QoL questionnaire are: on intent-to-treat analysis; fewer patients having GP visits in the trial group P=0.048 (18% vs 5%). In the per protocol subset; fewer episodes off work P=0.074 (range control 0–3 vs trial 0–2), GP visits P= 0.089 (range control 0–12 vs trial 0–3) and in the per-protocol minus re-operation group; GP visits P< 0.008 (range control 0–3 vs trial 0–2), patients requiring medication use P=0.05 (37% control vs 17% trial) days off work P=0.099 (range control 0–30 vs trial 0–3).

Discussion: The results reveal an advantage in terms of episodes off work, GP visits and medication use for participants in the trial group who completed the programme. Time off work is a significant consideration for funding providers. These results suggest that surgeons should consider referral of discectomy patients to appropriate post-surgical rehabilitation programmes.


The Bone & Joint Journal
Vol. 106-B, Issue 5 | Pages 515 - 515
1 May 2024
Kayani B D. Luo T S. Haddad F


The Bone & Joint Journal
Vol. 106-B, Issue 6 | Pages 639 - 639
1 Jun 2024
Davies A Sabharwal S Liddle AD Zamora Talaya MB Rangan A Reilly P


Bone & Joint Open
Vol. 4, Issue 11 | Pages 873 - 880
17 Nov 2023
Swaby L Perry DC Walker K Hind D Mills A Jayasuriya R Totton N Desoysa L Chatters R Young B Sherratt F Latimer N Keetharuth A Kenison L Walters S Gardner A Ahuja S Campbell L Greenwood S Cole A

Aims

Scoliosis is a lateral curvature of the spine with associated rotation, often causing distress due to appearance. For some curves, there is good evidence to support the use of a spinal brace, worn for 20 to 24 hours a day to minimize the curve, making it as straight as possible during growth, preventing progression. Compliance can be poor due to appearance and comfort. A night-time brace, worn for eight to 12 hours, can achieve higher levels of curve correction while patients are supine, and could be preferable for patients, but evidence of efficacy is limited. This is the protocol for a randomized controlled trial of ‘full-time bracing’ versus ‘night-time bracing’ in adolescent idiopathic scoliosis (AIS).

Methods

UK paediatric spine clinics will recruit 780 participants aged ten to 15 years-old with AIS, Risser stage 0, 1, or 2, and curve size (Cobb angle) 20° to 40° with apex at or below T7. Patients are randomly allocated 1:1, to either full-time or night-time bracing. A qualitative sub-study will explore communication and experiences of families in terms of bracing and research. Patient and Public Involvement & Engagement informed study design and will assist with aspects of trial delivery and dissemination.


Aims

Torus fractures of the distal radius are the most common fractures in children. The NICE non-complex fracture guidelines recently concluded that bandaging was probably the optimal treatment for these injuries. However, across the UK current treatment varies widely due to a lack of evidence underpinning the guidelines. The Forearm Fracture Recovery in Children Evaluation (FORCE) trial evaluates the effect of a soft bandage and immediate discharge compared with rigid immobilization.

Methods

FORCE is a multicentre, parallel group randomized controlled equivalence trial. The primary outcome is the Wong-Baker FACES pain score at three days after randomization and the primary analysis of this outcome will use a multivariate linear regression model to compare the two groups. Secondary outcomes are measured at one and seven days, and three and six-weeks post-randomization and include the Patient Reported Outcome Measurement Information System (PROMIS) upper extremity limb score, EuroQoL EQ-5D-Y, analgesia use, school absence, complications, and healthcare resource use. The planned statistical and health economic analyses for this trial are described here. The FORCE trial protocol has been published separately.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_3 | Pages 36 - 36
23 Feb 2023
Ma N Gogos S Moaveni A
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Surgical site infections following orthopaedic surgery are a serious complication associated with increased morbidity and mortality. Intra-wound antibiotic powder may be able to provide infection prophylaxis locally with less systemic adverse effects, and promising results have been reported in systematic reviews of its use in spine surgery. This study aims to analyse the efficacy and adverse effect profile of intra-wound antibiotics in reducing surgical site infections in orthopaedic surgery for traumatic pelvic and lower limb fractures. A systematic review was conducted for studies reporting on the incidence of surgical site infections following administration of intra-wound antibiotic powder in pelvic and lower limb trauma surgery. Randomised controlled trials, cohort and case-control studies were included. A meta-analysis was conducted for deep surgical site infections. Seven studies were included in the systematic review including six retrospective case-control studies and one randomised controlled trial. Results of the meta-analysis suggest a potential 23% reduction in the odds of developing a deep surgical site infection in patients treated with intra-operative antibiotic powder compared with those managed with intravenous antibiotics alone (OR 0.77, 95% CI 0.52 – 1.13), although the results did not reach statistical significance. Notable selective bias against intra-wound antibiotics and suboptimal study design were found in the retrospective studies, however the randomised controlled trial reported a significant reduction in deep surgical site infections with intra-wound vancomycin powder. There were no reports of systemic adverse outcomes and minimal risk of wound complications with the use of intra-wound antibiotics. This review suggests the use of intra-wound antibiotic powder in pelvic and lower limb trauma surgery may reduce the incidence of deep surgical site infections. Further powered studies including randomised controlled trials are required to confirm the results highlighted in this study


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_15 | Pages 50 - 50
7 Nov 2023
Bell K Oliver W White T Molyneux S Clement N Duckworth A
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This systematic review and meta-analysis aimed to compare the outcome of operative and non-operative management in adults with distal radius fractures, with an additional elderly subgroup analysis. The main outcome was 12-month PRWE score. Secondary outcomes included DASH score, grip strength, complications and radiographic parameters. Randomised controlled trials of patients aged ≥18yrs with a dorsally displaced distal radius fractures were included. Studies compared operative intervention with non-operative management. Operative management included open reduction and internal fixation, Kirschner-wiring or external fixation. Non-operative management was cast/splint immobilisation with/without closed reduction. Version 2 of the Cochrane risk-of-bias tool was used. After screening 1258 studies, 16 trials with 1947 patients (mean age 66yrs, 76% female) were included in the meta-analysis. Eight studies reported PRWE score and there was no clinically significant difference at 12 weeks (MD 0.16, 95% confidence interval [CI] −0.75 to 1.07, p=0.73) or 12 months (mean difference [MD] 3.30, 95% CI −5.66 to −0.94, p=0.006). Four studies reported on scores in the elderly and there was no clinically significant difference at 12 weeks (MD 0.59, 95% CI −0.35 to 1.53, p=0.22) or 12 months (MD 2.60, 95% CI −5.51 to 0.30, p=0.08). There was a no clinically significant difference in DASH score at 12 weeks (MD 10.18, 95% CI −14.98 to −5.38, p<0.0001) or 12 months (MD 3.49, 95% CI −5.69 to −1.29, p=0.002). Two studies featured only elderly patients, with no clinically important difference at 12 weeks (MD 7.07, 95% CI −11.77 to −2.37, p=0.003) or 12 months (MD 3.32, 95% CI −7.03 to 0.38, p=0.08). There was no clinically significant difference in patient-reported outcome according to PRWE or DASH at either timepoint in the adult group as a whole or in the elderly subgroup


Bone & Joint Research
Vol. 2, Issue 2 | Pages 33 - 40
1 Feb 2013
Palmer AJR Thomas GER Pollard TCB Rombach I Taylor A Arden N Beard DJ Andrade AJ Carr AJ Glyn-Jones S

Objectives

The number of surgical procedures performed each year to treat femoroacetabular impingement (FAI) continues to rise. Although there is evidence that surgery can improve symptoms in the short-term, there is no evidence that it slows the development of osteoarthritis (OA). We performed a feasibility study to determine whether patient and surgeon opinion was permissive for a Randomised Controlled Trial (RCT) comparing operative with non-operative treatment for FAI.

Methods

Surgeon opinion was obtained using validated questionnaires at a Specialist Hip Meeting (n = 61, 30 of whom stated that they routinely performed FAI surgery) and patient opinion was obtained from clinical patients with a new diagnosis of FAI (n = 31).


The Bone & Joint Journal
Vol. 99-B, Issue 12 | Pages 1590 - 1595
1 Dec 2017
Atrey A Ward SE Khoshbin A Hussain N Bogoch E Schemitsch EH Waddell JP

Aims

We present the ten-year data of a cohort of patients, aged between 18 and 65 years (mean age 52.7 years; 19 to 64), who underwent total hip arthroplasty. Patients were randomised to be treated with a cobalt-chrome (CoCr) femoral head with an ultra-high molecular weight polyethylene (UHMWPE), highly cross-linked polyethylene (XLPE) or ceramic-on-ceramic (CoC) bearing surface.

Patients and Methods

A total of 102 hips (91 patients) were randomised into the three groups. At ten years, 97 hips were available for radiological and functional follow-up. Two hips (two patients) had been revised (one with deep infection and one for periprosthetic fracture) and three were lost to follow-up. Radiological analysis was performed using a validated digital assessment programme to give linear, directional and volumetric wear of the two polyethylene groups.


Bone & Joint Research
Vol. 6, Issue 11 | Pages 631 - 639
1 Nov 2017
Blyth MJG Anthony I Rowe P Banger MS MacLean A Jones B

Objectives

This study reports on a secondary exploratory analysis of the early clinical outcomes of a randomised clinical trial comparing robotic arm-assisted unicompartmental knee arthroplasty (UKA) for medial compartment osteoarthritis of the knee with manual UKA performed using traditional surgical jigs. This follows reporting of the primary outcomes of implant accuracy and gait analysis that showed significant advantages in the robotic arm-assisted group.

Methods

A total of 139 patients were recruited from a single centre. Patients were randomised to receive either a manual UKA implanted with the aid of traditional surgical jigs, or a UKA implanted with the aid of a tactile guided robotic arm-assisted system. Outcome measures included the American Knee Society Score (AKSS), Oxford Knee Score (OKS), Forgotten Joint Score, Hospital Anxiety Depression Scale, University of California at Los Angeles (UCLA) activity scale, Short Form-12, Pain Catastrophising Scale, somatic disease (Primary Care Evaluation of Mental Disorders Score), Pain visual analogue scale, analgesic use, patient satisfaction, complications relating to surgery, 90-day pain diaries and the requirement for revision surgery.


The Bone & Joint Journal
Vol. 99-B, Issue 10 | Pages 1354 - 1365
1 Oct 2017
Patrick S McDowell A Lee A Frau A Martin U Gardner E McLorinan G Eames N

Aims

The aim of this study was to determine whether the sequential application of povidone iodine-alcohol (PVI) followed by chlorhexidine gluconate-alcohol (CHG) would reduce surgical wound contamination to a greater extent than PVI applied twice in patients undergoing spinal surgery.

Patients and Methods

A single-centre, interventional, two arm, parallel group randomised controlled trial was undertaken, involving 407 patients who underwent elective spinal surgery.

For 203 patients, the skin was disinfected before surgery using PVI (10% [w/w (1% w/w available iodine)] in 95% industrial denatured alcohol, povidone iodine; Videne Alcoholic Tincture) twice, and for 204 patients using PVI once followed by CHG (2% [w/v] chlorhexidine gluconate in 70% [v/v] isopropyl alcohol; Chloraprep with tint). The primary outcome measure was contamination of the wound determined by aerobic and anaerobic bacterial growth from samples taken after disinfection.


The Bone & Joint Journal
Vol. 99-B, Issue 7 | Pages 904 - 911
1 Jul 2017
Wall PDH Sprowson† AP Parsons NR Parsons H Achten J Balasubramanian S Thompson P Costa ML

Aims

The aim of this study was to compare the effectiveness of a femoral nerve block and a periarticular infiltration in the management of early post-operative pain after total knee arthroplasty (TKA).

Patients and Methods

A pragmatic, single centre, two arm parallel group, patient blinded, randomised controlled trial was undertaken. All patients due for TKA were eligible. Exclusion criteria included contraindications to the medications involved in the study and patients with a neurological abnormality of the lower limb. Patients received either a femoral nerve block with 75 mg of 0.25% levobupivacaine hydrochloride around the nerve, or periarticular infiltration with 150 mg of 0.25% levobupivacaine hydrochloride, 10 mg morphine sulphate, 30 mg ketorolac trometamol and 0.25 mg of adrenaline all diluted with 0.9% saline to make a volume of 150 ml.


The Bone & Joint Journal
Vol. 99-B, Issue 5 | Pages 577 - 584
1 May 2017
Nebergall AK Greene ME Laursen MB Nielsen PT Malchau H Troelsen A

Aims

The objective of this five-year prospective, blinded, randomised controlled trial (RCT) was to compare femoral head penetration into a vitamin E diffused highly cross-linked polyethylene (HXLPE) liner with penetration into a medium cross-linked polyethylene control liner using radiostereometric analysis.

Patients and Methods

Patients scheduled for total hip arthroplasty (THA) were randomised to receive either the study E1 (32 patients) or the control ArComXL polyethylene (35 patients). The median age (range) of the overall cohort was 66 years (40 to 76).


The Bone & Joint Journal
Vol. 99-B, Issue 3 | Pages 383 - 392
1 Mar 2017
Handoll HH Keding A Corbacho B Brealey SD Hewitt C Rangan A

Aims

The PROximal Fracture of the Humerus Evaluation by Randomisation (PROFHER) randomised clinical trial compared the operative and non-operative treatment of adults with a displaced fracture of the proximal humerus involving the surgical neck. The aim of this study was to determine the long-term treatment effects beyond the two-year follow-up.

Patients and Methods

Of the original 250 trial participants, 176 consented to extended follow-up and were sent postal questionnaires at three, four and five years after recruitment to the trial. The Oxford Shoulder Score (OSS; the primary outcome), EuroQol 5D-3L (EQ-5D-3L), and any recent shoulder operations and fracture data were collected. Statistical and economic analyses, consistent with those of the main trial were applied.


The Bone & Joint Journal
Vol. 99-B, Issue 1 | Pages 107 - 115
1 Jan 2017
Carr A Cooper C Campbell MK Rees J Moser J Beard DJ Fitzpatrick R Gray A Dawson J Murphy J Bruhn H Cooper D Ramsay C

Aims

The appropriate management for patients with a degenerative tear of the rotator cuff remains controversial, but operative treatment, particularly arthroscopic surgery, is increasingly being used. Our aim in this paper was to compare the effectiveness of arthroscopic with open repair of the rotator cuff.

Patients and Methods

A total of 273 patients were recruited to a randomised comparison trial (136 to arthroscopic surgery and 137 to open surgery) from 19 teaching and general hospitals in the United Kingdom. The surgeons used their usual preferred method of repair. The Oxford Shoulder Score (OSS), two years post-operatively, was the primary outcome measure. Imaging of the shoulder was performed at one year after surgery. The trial is registered with Current Controlled Trials, ISRCTN97804283.


The Bone & Joint Journal
Vol. 99-B, Issue 1 | Pages 51 - 58
1 Jan 2017
van der Woude JAD Wiegant K van Heerwaarden RJ Spruijt S Emans PJ Mastbergen SC Lafeber FPJG

Aims

Knee joint distraction (KJD) is a relatively new, knee-joint preserving procedure with the goal of delaying total knee arthroplasty (TKA) in young and middle-aged patients. We present a randomised controlled trial comparing the two.

Patients and Methods

The 60 patients ≤ 65 years with end-stage knee osteoarthritis were randomised to either KJD (n = 20) or TKA (n = 40). Outcomes were assessed at baseline, three, six, nine, and 12 months. In the KJD group, the joint space width (JSW) was radiologically assessed, representing a surrogate marker of cartilage thickness.


Aims

The optimal treatment for independent patients with a displaced intracapsular fracture of the hip remains controversial. The recognised alternatives are hemiarthroplasty and total hip arthroplasty. At present there is no established standard of care, with both types of arthroplasty being used in many centres.

Patients and Methods

We conducted a feasibility study comparing the clinical effectiveness of a dual mobility acetabular component compared with standard polyethylene component in total hip arthroplasty for independent patients with a displaced intracapsular fracture of the hip, for a 12-month period beginning in June 2013. The primary outcome was the risk of dislocation one year post-operatively. Secondary outcome measures were EuroQol 5 Dimensions, ICEpop CAPability measure for Older people, Oxford hip score, mortality and re-operation.


The Bone & Joint Journal
Vol. 98-B, Issue 10 | Pages 1333 - 1341
1 Oct 2016
van der Voort P Valstar ER Kaptein BL Fiocco M van der Heide HJL Nelissen RGHH

Aims

The widely used and well-proven Palacos R (a.k.a. Refobacin Palacos R) bone cement is no longer commercially available and was superseded by Refobacin bone cement R and Palacos R + G in 2005. However, the performance of these newly introduced bone cements have not been tested in a phased evidence-based manner, including roentgen stereophotogrammetric analysis (RSA).

Patients and Methods

In this blinded, randomised, clinical RSA study, the migration of the Stanmore femoral component was compared between Refobacin bone cement R and Palacos R + G in 62 consecutive total hip arthroplasties. The primary outcome measure was femoral component migration measured using RSA and secondary outcomes were Harris hip score (HHS), Hip disability and Osteoarthritis Outcome Score (HOOS), EuroQol 5D (EQ-5D) and Short Form 36 (SF-36).


The Bone & Joint Journal
Vol. 98-B, Issue 7 | Pages 939 - 944
1 Jul 2016
Boonen B Schotanus MGM Kerens B van der Weegen W Hoekstra HJ Kort NP

Aims

We wished to compare the clinical outcome, as assessed by questionnaires and the rate of complications, in total knee arthroplasty (TKA) undertaken with patient-matched positioning guides (PMPGs) or conventional instruments.

Patients and Methods

A total of 180 patients (74 men, 106 women; mean age 67 years) were included in a multicentre, adequately powered, double-blind, randomised controlled trial. The mean follow-up was 44 months (24 to 57).


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_2 | Pages 97 - 97
1 Mar 2021
D'sa P Roberts G Williams M
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Abstract. Background. Recruitment of patients to participate in Randomised control trials (RCTs) is a challenging task, especially for trauma trials in which the identification and recruitment are time-limited. Multiple strategies have been tried to improve the participation of doctors and recruitment of patients. Aim. To study the effect of a trainee advocate (trainee Principal investigator-tPI) on influencing junior doctors to take part in trials and its effect on recruitment for a multicenter prospective hip fracture RCT. Methods. A retrospective study comparing the number of junior doctors participating in trials and patients recruited before and after the introduction of informal tPI role at UHW Cardiff. Results. The target recruitment set by the central trial unit was 9/month. Excluding the research team, there were 6 trainees actively recruiting in the before period (Feb’19-July’19) in comparison with 12 in the after period (Sept’19-Feb’20). TPI had a direct influence on 9 of the 11 trainees to get involved in the trials by guidance and nudging. There were 105 eligible patients of which 62 were recruited (59% of eligible pts, 115% of target) in the before period in comparison with 102 recruited (76% of eligible pts, 189% of target) out of the 135 eligible patients in the after period. The proportion of recruitment done by the research team to that of trainees was 79%:21% in the before period in comparison with 30%:70% in the after period further improving to 15%:85% in the last 3 months. Conclusion. TPI can work alongside the PI and research team to be a valuable link person coordinating and engaging local trainees to take part in trials. This may be particularly beneficial in hospitals where there is no dedicated research team. TPI role could be formalized for many trials and can be used as a leadership & management potential building experience for trainees. Declaration of Interest. (b) declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research reported:I declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research project


Bone & Joint Research
Vol. 4, Issue 6 | Pages 93 - 98
1 Jun 2015
Smith NA Achten J Parsons N Wright D Parkinson B Thompson P Hutchinson CE Spalding T Costa ML

Objectives

Subtotal or total meniscectomy in the medial or lateral compartment of the knee results in a high risk of future osteoarthritis. Meniscal allograft transplantation has been performed for over thirty years with the scientifically plausible hypothesis that it functions in a similar way to a native meniscus. It is thought that a meniscal allograft transplant has a chondroprotective effect, reducing symptoms and the long-term risk of osteoarthritis. However, this hypothesis has never been tested in a high-quality study on human participants. This study aims to address this shortfall by performing a pilot randomised controlled trial within the context of a comprehensive cohort study design.

Methods

Patients will be randomised to receive either meniscal transplant or a non-operative, personalised knee therapy program. MRIs will be performed every four months for one year. The primary endpoint is the mean change in cartilage volume in the weight-bearing area of the knee at one year post intervention. Secondary outcome measures include the mean change in cartilage thickness, T2 maps, patient-reported outcome measures, health economics assessment and complications.