Dataset Information

Ultrasound-guided tendon fenestration versus open-release surgery for the treatment of chronic lateral epicondylosis of the elbow: protocol for a prospective, randomised, single blinded study.

ABSTRACT: INTRODUCTION:Chronic lateral epicondylosis (CLE) of the elbow is a prevalent condition among middle-aged people with no consensus on optimal care management but for which surgery is generally accepted as a second intention treatment. Among conservative treatment options, ultrasound (US)-guided fenestration has shown encouraging results that should be explored before surgery is considered. The primary objective of this study is to compare the efficacy of US-guided fenestration with open-release surgery in patients with failure to improve following a minimum 6 months of conservative treatment. METHODS AND ANALYSIS:This study protocol entails a two-arm, single-blinded, randomised, controlled design. Sixty-four eligible patients with clinically confirmed CLE will be assigned to either US-guided fenestration or open-release surgery. Fisher's exact test will be used to compare the proportion of patients reporting a change of 11/100 points or more in the Patient Rated Tennis Elbow Evaluation score at 6 months, according to an intention-to-treat analysis. Secondary analyses will compare the two treatment groups in terms of pain and disability, functional limitations at work, pain-free grip strength, medication burden, patients' global impression of change and level of satisfaction at 6 weeks, 3, 6 and 12 months, using mixed linear models for repeated measures or Fisher's exact test, as appropriate. Finally, recursive partitioning analyses will investigate US and elastography parameters as predictors of treatment success at 6 and 12 months. This data will contribute to evidence-based treatment guidelines for CLE and explore the value of imaging biomarkers to improve risk stratification plans and assist clinicians. ETHICS AND DISSEMINATION:The study has been approved by the Research Ethics Board of our institution on 23 March 2016 (REB 15.327). In case of important protocol modifications, a new version of the protocol with appropriate amendments will be submitted to the REB for approval. Study results will be published in peer-reviewed journals and presented at local, national and international conferences. TRIAL REGISTRATION NUMBER:NCT02710682.

SUBMITTER: Lungu E

PROVIDER: S-EPMC6009557 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Ultrasound-guided tendon fenestration versus open-release surgery for the treatment of chronic lateral epicondylosis of the elbow: protocol for a prospective, randomised, single blinded study.

Lungu Eugen E Grondin Philippe P Tétreault Patrice P Desmeules François F Cloutier Guy G Choinière Manon M Bureau Nathalie J NJ

BMJ open 20180609 6

<h4>Introduction</h4>Chronic lateral epicondylosis (CLE) of the elbow is a prevalent condition among middle-aged people with no consensus on optimal care management but for which surgery is generally accepted as a second intention treatment. Among conservative treatment options, ultrasound (US)-guided fenestration has shown encouraging results that should be explored before surgery is considered. The primary objective of this study is to compare the efficacy of US-guided fenestration with open-r ...[more]

PMID: 29886446

Similar Datasets

Project description:BackgroundCarpal tunnel release (CTR) is a surgical treatment option for patients with carpal tunnel syndrome (CTS) symptoms that are unresponsive to conservative treatment. Most patients experience symptomatic relief after CTR regardless of the surgical technique. However, direct comparisons of the safety and effectiveness between CTR surgical techniques are limited. The purpose of this randomized controlled trial is to compare the safety and effectiveness of CTR with ultrasound guidance (CTR-US) versus mini-open CTR (mOCTR) in subjects with symptomatic CTS.Design and methodsTUTOR (Trial of Ultrasound guided CTR versus Traditional Open Release) is a randomized controlled trial in which 120 subjects at up to 12 sites in the United States will be randomized (2:1) to receive CTR-US or mOCTR. The primary endpoint of the study is the percentage of patients who return to normal daily activities within 3 days of the procedure. Secondary endpoints of the study are median time to return to normal daily activities, percentage of patients who return to work within 3 days of the procedure, median time to return to work, Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) change score at 3 months, BCTQ Functional Status Scale (BCTQ-FSS) change score at 3 months, Numeric Pain Scale change score at 3 months, EuroQoL-5 Dimension 5-Level (EQ-5D-5L) change score at 3 months, and the incidence of device- or procedure-related adverse events at 3 months. Patient follow-up in this trial will continue for 1 year.Ethics and disseminationThis study was approved by a central institutional review board and ongoing trial oversight will be provided by a data safety monitoring board (DSMB). The authors intend to report the results of this trial at medical conferences and peer-reviewed journals. The outcomes of TUTOR will have important clinical and economic implications for all stakeholders involved in treating patients with CTS.Study registrationClinicalTrials.gov (https://clinicaltrials.gov): NCT05405218.Level of evidence1.

Project description:BACKGROUND:Posttraumatic elbow contractures in children and adolescents are challenging to manage, and studies investigating surgical treatment are limited by the rarity of this condition. Small case series have shown variable gains in immediate and long-term elbow arc of motion after open surgical release. We reviewed our experience with open surgical release of posttraumatic elbow contracture in patients <21 years old at 2 institutions. METHODS:A retrospective chart review identified patients who underwent posttraumatic open elbow contracture release by 2 surgeons at 2 institutions between 2006 and 2013. Nontraumatic contractures and arthroscopic releases were excluded. Twenty-six patients were included in this study. Mean age at the time of injury was 12 years (5 to 19 y) and at the time of surgery was 14 years (7 to 20 y). Capsulotomy, osteoplasty, removal of hardware, ulnar nerve release or transposition, and ligament reconstruction were performed through medial and lateral approaches as indicated by the pathology. Ten patients had ligament repair or stabilization, and 16 patients used a continuous passive motion (CPM) postoperatively. Outcomes included active range of motion and complications. RESULTS:Mean time from injury to surgical release was 29 months. Mean postoperative follow-up was 42 months. Elbow active flexion-extension and forearm rotation arcs both increased significantly by a mean of 49 and 70 degrees, respectively, at final follow-up. A mean 85% of intraoperative flexion-extension arc was maintained at final follow-up. Ligament repair or reconstruction and the use of a postoperative CPM did not significantly change these outcomes. Outcomes were not significantly different if our contracture release was performed within a year from injury. Patients who had surgery before our contracture release had decreased restoration of forearm rotation after release. Complications included 2 recurrent contractures (1 used a CPM and 1 did not), and 2 postoperative ulnar neuropathies (1 used a CPM and 1 did not). CONCLUSIONS:Open contracture release for posttraumatic elbow contracture in an adolescent population can significantly improve active range of motion. LEVEL OF EVIDENCE:Level 3-therapeutic.

Project description:AIM:To investigate the effectiveness of ultrasound-guided release of the first annular pulley and compare results with the conventional open operative technique. METHODS:In this prospective randomized, single-center, clinical study, 32 patients with trigger finger or trigger thumb, grade II-IV according to Green classification system, were recruited. Two groups were formed; Group A (16 patients) was treated with an ultrasound-guided percutaneous release of the affected A1 pulley under local anesthesia. Group B (16 patients) underwent an open surgical release of the A1 pulley, through a 10-15 mm incision. Patients were assessed pre- and postoperatively (follow-up: 2, 4 and 12 wk) by physicians blinded to the procedures. Treatment of triggering (primary variable of interest) was expressed as the "success rate" per digit. The time for taking postoperative pain killers, range of motion recovery, QuickDASH test scores (Greek version), return to normal activities (including work), complications and cosmetic results were assessed. RESULTS:The success rate in group A was 93.75% (15/16) and in group B 100% (16/16). Mean times in group A patients were 3.5 d for taking pain killers, 4.1 d for returning to normal activities, and 7.2 and 3.9 d for complete extension and flexion recovery, respectively. Mean QuickDASH scores in group A were 45.5 preoperatively and, 7.5, 0.5 and 0 after 2, 4, and 12 wk postoperatively. Mean times in group B patients were 2.9 d for taking pain killers, 17.8 d for returning to normal activities, and 5.6 and 3 d for complete extension and flexion recovery. Mean QuickDASH scores in group B were 43.2 preoperatively and, 8.2, 1.3 and 0 after 2, 4, and 12 wk postoperatively. The cosmetic results found excellent or good in 87.5% (14/16) of group A patients, while in 56.25% (9/16) of group B patients were evaluated as fair or poor. CONCLUSION:Treatment of the trigger finger using ultrasonography resulted in fewer absence of work days, and better cosmetic results, in comparison with the open surgery technique. It is a promising method that represents excellent results without major complications, so that it could be possibly be established as a first-line treatment in the trigger finger's disease.

Dataset Information

Ultrasound-guided tendon fenestration versus open-release surgery for the treatment of chronic lateral epicondylosis of the elbow: protocol for a prospective, randomised, single blinded study.

Publications

Ultrasound-guided tendon fenestration versus open-release surgery for the treatment of chronic lateral epicondylosis of the elbow: protocol for a prospective, randomised, single blinded study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets