Skip to main content
OpenTrials
Completed

NCT Number: NCT03315819

Anterior Capsulo-labral Reinsertion by Arthroscopic Approach Versus Immobilization

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bankart Lesion Bankart Lesions Fractures, Bone Joint Diseases Joint Dislocations Musculoskeletal Diseases Shoulder Dislocation Shoulder Fractures Shoulder Injuries Wounds and Injuries

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Roger Salengro

Lille, 59000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with inclusive on the day of dislocation.
  • First episode of anterior glenohumeral dislocation without associated humeral fracture confirmed by a standard radiograph.

Exclusion criteria

  • Dislocation without trauma, in a context of hyper laxity with a Beighton score ≥4 / 97.8. In these patients post-dislocation MRI was performed in the Robinson study, which found no capsulo-labral lesion.
  • Bone glenoid defect> 25% at the scanner (Bony Bankart).
  • Delay greater than 15 days between luxation and surgical treatment
  • Against indication to anesthesia
  • Pregnant or nursing women

Treatment and study plan

Bankart repair

Procedure

Arthroscopic repair of anterior capsulo-labral lesions using the Bankart technique.

Immobilization interne rotation

Procedure

Immobilisation in rotation Internal (Dujarrier) 3 weeks then rehabilitation

Primary outcomes

  1. Number of occurrence of a recurrence during the follow-up period of 2 years

    Time frame: at 2 years

Secondary outcomes

  1. Number of recidivism of dislocation with the necessity of reduction by a third person

    Time frame: at 3 months, 6 months, 1 years and 2 years

  2. number of episodes of subluxations reported by the patient at the interview

    Time frame: at 3 months, 6 months, 1 years and 2 years

  3. Goniometer measurement of the angle in the ankle joint

    Time frame: at 3 months, 6 months, 1 years and 2 years

  4. Walch Duplay Score

    Time frame: at 3 months, 6 months, 1 years and 2 years

    Auto questionnaire designed to measure the impact of shoulder instability, activity, pain mobility.total point up to 100 : excellent, good, medium, poor

  5. Disabilities of the Arm, Shoulder and Hand (DASH) Score

    Time frame: at 3 months, 6 months, 1 years and 2 years

    Auto questionnaire designed to measure the quality of life of patients.

  6. Western Ontario Shoulder Instability (WOSI) Score.

    Time frame: at 3 months, 6 months, 1 years and 2 years

    Auto questionnaire designed to measure the impact of shoulder instability on the quality of life of patients. percentage of lifestyle, emotion, physical symptome.

  7. Likert Scale

    Time frame: at 2 years

    Overall patient satisfaction

  8. The duration of work stoppage

    Time frame: at 2 years

  9. Time lapse - resumption of sports activities and level of sport practiced

    Time frame: At 6 months, 1 years and 2 years

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: BANKART

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Oct 20, 2017
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.