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Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_2 | Pages 34 - 34
1 Jan 2014
Refaie R Chong M Murty A Reed M
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Introduction:

Symptomatic treatment of ankle osteoarthritis (OA) with corticosteroid injections is well established. Hyaluronic acid is also reported as an effective symptomatic treatment for ankle OA but these two treatments have not been compared directly.

Methods:

A prospective randomised controlled trial in patients with symptomatic ankle osteoarthritis. Twenty patients per group were required based on a significance level of 0.05, and a drop out rate of 5%. Patients were blindly allocated to the treatment or control group. Injections were carried out by the clinician in the outpatient department. Treatment group received Ostenil 20 mg and control group received Depomedrone 40 mg (both as single injections). The treatment arm was allocated by computer generated block randomization to match treatment allocation with grade of arthritis. The primary outcome measure was the change in Visual Analogue Scale (VAS) pain score at 6 months. Secondary outcome was the change in AOFAS score at 6 months. Research ethics committee approval was obtained.


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_14 | Pages 26 - 26
1 Dec 2015
Baumhauer J Singh D Glazebrook M Blundell C Wansbrough G de Vries G Le I Nielson D Petersen E Sakellariou A Solan M Younger A Daniels T
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Patients with advanced stage hallux rigidus from 12 centers in Canada and the UK were randomized (2:1) to treatment with a small (8/10 mm) hydrogel implant (Cartiva) or 1st MTP arthrodesis. VAS pain scale, validated outcome measures (FAAM sport scale), great toe active dorsiflexion motion, secondary procedures, radiographic assessment and safety parameters were evaluated.

236 patients were initially enrolled, 17 patients withdrew prior to randomization, 17 patients withdrew after randomization and 22 were non-randomized training patients, leaving 152 implant and 50 arthrodesis patients. Standard demographics and baseline outcomes were similar for both groups.

Mean VAS pain scores decreased from 6.8 and 6.9 respectively for the implant and arthrodesis groups from baseline to 1.4 and 0.7 at 24 months. Similarly, the FAAM sports score improved significantly from baseline levels of 37 and 36 to 24 months level of 77 and 82 respectively for the implant and arthrodesis groups. First MTP active dorsiflexion motion improved an average of 4° at 3 months after implant placement and was maintained at 24 months.

Secondary surgeries occurred in 17 (11.2%) implant patients and 6 (12.0%) arthrodesis patients. Fourteen (9.2%) implants were removed and converted to arthrodesis and 6 (12.0%) arthrodesis patients had painful hardware requiring removal. There was no case of implant fragmentation, wear, or bone loss. Analysis of a single composite endpoint utilizing the three primary study outcomes (pain, function, and safety) showed statistical equivalence between the2groups.

Conclusion

In patients requiring surgery for advanced stage hallux rigidus, treatment with a small synthetic cartilage implant resulted in comparable clinically important pain relief and functional outcomes compared to 1st MTP arthrodesis while preserving and often improving great toe motion. Secondary surgical intervention was similar in the implant and arthrodesis groups. Revision from a small implant plug to arthrodesis can be performed if needed.


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_XXII | Pages 43 - 43
1 May 2012
Kotwal R Paringe V Rath N Lyons K
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Injury to the syndesmosis occurs in approximately 10% of all patients with ankle fractures. Anatomic restoration of the syndesmosis is the only significant predictor of functional outcome. Several techniques of syndesmosis fixation are currently used such as cortical screws, bioabsorbable screws and more recently introduced suture-button fixation. No single technique has been shown to be superior to the others.

The objective of this research project is to investigate whether treatment with a tightrope (suture-button fixation) gives superior results than the use of a cortical screw in the treatment of acute syndesmotic ankle injuries with regards to function, pain, satisfaction and return to normal activities.

Research Ethics Committee approval was obtained. 40 patients with syndesmotic ankle injuries associated with diastasis were prospectively recruited, 20 in each group. Patients were randomized to one of the 2 groups. At 12 weeks, American Orthopaedic Foot and Ankle Society (AOFAS) scores and a computerized tomography (CT) scan of both the ankles was obtained. At 1 year, AOFAS scores and satisfaction was assessed.

32 patients have been recruited so far, 20 in the tightrope group and 12 in the cortical screw group. Mean AOFAS scores at 3 months post-op were 90.67 in the Tightrope group and 84 in the screw group. The difference was not significant (p= 0.096). CT scans revealed that the quality of syndesmosis reduction was equally good with both the techniques. Metalwork prominence was common with both the devices.

Discussion and Conclusion

Both the devices achieved good reduction of the syndesmosis. Our CT scan protocol has insignificant radiation risk and allows more accurate assessment of the syndesmosis. Early clinical results do not show a significant difference in the functional outcome with the use of either device. Long-term (1 year) follow-up has been planned.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_12 | Pages 3 - 3
10 Jun 2024
Alsousou J Keene D Harrison P O'Connor H Wagland S Dutton S Hulley P Lamb S Willett K
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Background. The PATH-2 trial found no evidence of a benefit of Platelet Rich Plasma (PRP) injection versus a placebo after Achilles tendon rupture (ATR) at six-months. ATR often leave longer-term functional deficiencies beyond six-months. This study aim is to determine if PRP affect tendon functional outcomes at two-years after rupture. Study design. Randomised multi-centre two-arm parallel-group, participant- and assessor-blinded, superiority trial. Methods. Adults with acute ATR managed non-surgically were recruited in 19 UK hospitals from 2015 to 2019. Exclusions were insertion or musculotendinous injuries, leg injury or deformity, diabetes, haematological disorder, corticosteroids and anticoagulation therapy. Participants were randomised via an online system 1:1 to PRP or placebo. Primary outcome was Achilles Tendon Rupture Score (ATRS) at two-years. Secondary outcomes were pain, Patient-Specific Functional Scale (PSFS), SF-12 and re-rupture. Assessors were blinded. Intention-to-treat and Compliance Average Causal effects (CACE) analyses were carried out. Consistency of effects across subgroups age, BMI, smoking and gender were assessed using Forest plots. Pearson's correlation was used to explore ATRS correlation with blood and growth factors. Results. 216/230 (94%) participants completed the 6-months follow-up were contacted. 182/216 (84%) completed the two-year follow-up. Participants were aged mean 46 (SD 13.0), 57 female/159 male. 96% received the allocated intervention. Two-years ATRS scores were 82.2 (SD 18.3) in the PRP group (n=85) and 83.8 (SD 16.0) in the placebo group (n=92). There was no evidence of a difference in the two-years ATRS (adjusted-mean difference −0.752 95%CI −5.523 to 4.020, p=0.757), or in any secondary outcome, and no re-rupture between at two-years. Neither PRP cellular or growth factors correlated with the two-year ATRS. Conclusion. PRP did not improve patient-reported function or quality of life two-years after acute Achilles tendon rupture, compared with placebo, indicating that PRP offers no patient benefit in the longer term


Bone & Joint Open
Vol. 2, Issue 8 | Pages 631 - 637
10 Aug 2021
Realpe AX Blackstone J Griffin DR Bing AJF Karski M Milner SA Siddique M Goldberg A

Aims

A multicentre, randomized, clinician-led, pragmatic, parallel-group orthopaedic trial of two surgical procedures was set up to obtain high-quality evidence of effectiveness. However, the trial faced recruitment challenges and struggled to maintain recruitment rates over 30%, although this is not unusual for surgical trials. We conducted a qualitative study with the aim of gathering information about recruitment practices to identify barriers to patient consent and participation to an orthopaedic trial.

Methods

We collected 11 audio recordings of recruitment appointments and interviews of research team members (principal investigators and research nurses) from five hospitals involved in recruitment to an orthopaedic trial. We analyzed the qualitative data sets thematically with the aim of identifying aspects of informed consent and information provision that was either unclear, disrupted, or hindered trial recruitment.


The Bone & Joint Journal
Vol. 99-B, Issue 12 | Pages 1629 - 1636
1 Dec 2017
Sheth U Wasserstein D Jenkinson R Moineddin R Kreder H Jaglal S

Aims

To determine whether the findings from a landmark Canadian trial assessing the optimal management of acute rupture of the Achilles tendon influenced the practice patterns of orthopaedic surgeons in Ontario, Canada.

Materials and Methods

Health administrative databases were used to identify Ontario residents ≥ 18 years of age with an Achilles tendon rupture from April 2002 to March 2014. The rate of surgical repair (per 100 cases) was calculated for each calendar quarter. A time-series analysis was used to determine whether changes in the rate were chronologically related to the dissemination of results from a landmark trial published in February 2009. Non-linear spline regression was then used independently to identify critical time-points of change in the surgical repair rate to confirm the findings.


The Journal of Bone & Joint Surgery British Volume
Vol. 92-B, Issue 5 | Pages 646 - 650
1 May 2010
Healy B Beasley R Weatherall M

We report an audit of 208 patients with a mean age of 39 years (16 to 65) attending the Orthopaedic Assessment Unit at the Wellington Hospital between January 2006 and December 2007 with an injury of the tendo Achillis requiring immobilisation in a cast. Information on assessment of venous thromboembolism (VTE) risk, prophylactic measures and VTE events for all patients was obtained from the medical records. A VTE risk factor was documented in the records of three (1%) patients. One of the 208 patients received aspirin prophylaxis; none received low molecular weight heparin. In all, 13 patients (6.3%, 95% confidence interval 3.4 to 10.5) developed symptomatic VTE during immobilisation in a cast, including six with a distal deep-vein thrombosis (DVT), four with a proximal DVT, and three with a confirmed pulmonary embolus. This incidence of symptomatic VTE is similar to that reported following elective hip replacement.

We propose that consideration is given to VTE prophylaxis during prolonged immobilisation of the lower limbs in a cast, to ensure that the same level of protection is provided as for patients undergoing elective hip replacement.