Clinical Trials Directory

Trials / Completed

CompletedNCT03315819

Anterior Capsulo-labral Reinsertion by Arthroscopic Approach Versus Immobilization

First Episode of Anterior Glenohumeral Dislocation in Adult Patients Under 25 Years of Age: Anterior Capsulo-labral Reinsertion by Arthroscopic Approach Versus Immobilization "

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (actual)
Sponsor
University Hospital, Lille · Academic / Other
Sex
All
Age
18 Years – 25 Years
Healthy volunteers
Not accepted

Summary

The risk of recurrence and chronic instability after an initial episode of anterior glenohumeral dislocation is high, the risk is higher the younger the patient is. Most patients with recurrences develop this instability during the first 2 years. Several studies have shown that an initial arthroscopic surgical treatment (Bankart intervention) decreased the risk of recurrence and therefore of chronic instability, but this attitude is not usual in France and none randomized study comparing intervention of arthroscopic Bankart and immobilization was published by a French team. The primary objective was to evaluate at 2 years the efficacy on the rate of recurrent instability of the first-line arthroscopic repair of prior capsulo-labral lesions compared to conservative treatment by immobilization for patients under 25 years having an initial episode of anterior glenohumeral dislocation Material and method : We conducted a randomized controlled, open-label, parallel-group study (conservative treatment group by immobilizing VS surgical treatment group) in patients aged 18 to 25 with anterior glenohumeral primo luxation. Patients were clinically reassessed at 2 years with functional scores (WOSI, DuplayWalch, DASH), mobility and instability recurrence. Hypothesis: reduction of the recurrence rate in the surgically treated group

Conditions

Interventions

TypeNameDescription
PROCEDUREBankart repairArthroscopic repair of anterior capsulo-labral lesions using the Bankart technique.
PROCEDUREImmobilization interne rotationImmobilisation in rotation Internal (Dujarrier) 3 weeks then rehabilitation

Timeline

Start date
2014-03-27
Primary completion
2019-03-26
Completion
2019-03-26
First posted
2017-10-20
Last updated
2025-12-22

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03315819. Inclusion in this directory is not an endorsement.