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01.12.2006 | Study protocol | Ausgabe 1/2006 Open Access

Trials 1/2006

A multi-centre randomized controlled trial comparing electrothermal arthroscopic capsulorrhaphy versus open inferior capsular shift for patients with shoulder instability: Protocol implementation and interim performance: Lessons learned from conducting a multi-centre RCT [ISRCTN68224911; NCT00251160]

Zeitschrift:
Trials > Ausgabe 1/2006
Autoren:
NG Mohtadi, RM Hollinshead, PJ Ceponis, DS Chan, GH Fick
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​1745-6215-7-4) contains supplementary material, which is available to authorized users.

Competing interests

The ETAC probes (Oratec Vulcan Generator electro-thermal system) used in this trial are donated by Oratec Interventions Inc., Menlo Park, CA, USA. NM has received outside funding from Oratec and Smith & Nephew USA to support the annual collaborator meetings for the trial. Absolutely none of this industry support has been used to conduct the trial in any fashion. Peer review funding was obtained initially from The Arthritis Society and subsequently from the Canadian Institutes for Health Research to provide all resources to carry out the multi-centre trial.

Authors' contributions

NM, RH, TS, AK (deceased) and GF formed the original study team that developed the research question, wrote the study protocol obtained local ethics approval, obtained grant funding and implemented this study. NM, PC and DC drafted and revised this article. RH and GF revised this article.

Abstract

Background

The shoulder is the most frequently dislocated joint in the body. Multiple causes and pathologies account for the various types of shoulder instability. Multi-directional instability (MDI) and multi-directional laxity with antero-inferior instability (MDL-AII) are similar in pathology, less common and more difficult to treat. These instabilities are caused by ligamentous capsular redundancy. When non-operative management fails for these patients, quality of life is significantly impaired and surgical treatment is required to tighten the ligaments and joint capsule. The current reference (gold) standard treatment for MDI/MDL-AII is an open inferior capsular shift (ICS) surgical procedure. An alternative treatment involves arthroscopic thermal shrinkage of redundant capsular tissue to tighten the joint. However, there is a lack of scientific evidence to support the use of this technique called, electrothermal arthroscopic capsulorrhaphy (ETAC). This trial will compare the effectiveness of ETAC to open ICS in patients with MDI and MDL-AII, using patient-based quality of life outcome assessments.

Methods

This study is a multi-centre randomized clinical trial with a calculated sample size of 58 patients (p = 0.05, 80% power). Eligible patients are clinically diagnosed with MDI or MDL-AII and have failed standardized non-operative management. A diagnostic shoulder arthroscopy is performed to confirm eligibility, followed by intra-operative randomization to the ETAC or ICS surgical procedure. The primary outcome is the disease-specific quality of life questionnaire (Western Ontario Shoulder Instability Index), measured at baseline, 3, 6, 12 and 24 months. Secondary outcomes include shoulder-specific measures (American Shoulder and Elbow Surgeons Score and Constant Score). Other outcomes include recurrent instability, complications and operative time.
The outcome measurements will be compared on an intention-to-treat basis, using two-sample independent t-tests to assess statistical significance. A Generalized Estimated Equations (GEE) analysis will determine whether there is an effect over time.

Discussion

This ongoing trial has encountered unexpected operational and practical issues, including slow patient enrollment due to high intra-operative exclusion rates. However, the authors have a greater understanding of multi-directional laxity in the shoulder and anticipate the results of this trial will provide the medical community with the best scientific clinical evidence on the efficacy of ETAC compared to open ICS.
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