Anterior Capsulo-labral Reinsertion by Arthroscopic Approach Versus Immobilization

NCT03315819 | Completed

• 2 other identifiers: 2013_302013-A01720-45
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Bankart Lesion

Keywords

glenohumeral dislocation; Arthroscopic; capsular lesions

Outcome Measures

Primary Outcomes (1)

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

  at 2 years

Secondary Outcomes (9)

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

  at 3 months, 6 months, 1 years and 2 years

• number of episodes of subluxations reported by the patient at the interview

  at 3 months, 6 months, 1 years and 2 years

• Goniometer measurement of the angle in the ankle joint

  at 3 months, 6 months, 1 years and 2 years

• Walch Duplay Score

  at 3 months, 6 months, 1 years and 2 years

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

  at 3 months, 6 months, 1 years and 2 years

Study Arms (2)

Bankart repair

EXPERIMENTAL

Arthroscopic repair of anterior capsulo-labral lesions using the Bankart technique. The procedure must be performed within 15 days of dislocation.

Procedure: Bankart repair

Immobilization interne rotation

ACTIVE COMPARATOR

Immobilization of the shoulder during 3 weeks

Procedure: Immobilization interne rotation

Interventions

Bankart repair PROCEDURE

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

Bankart repair

Immobilization interne rotation PROCEDURE

Immobilisation in rotation Internal (Dujarrier) 3 weeks then rehabilitation

Immobilization interne rotation

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hôpital Roger Salengro

Lille, 59000, France

Location

Related Publications (2)

• Pouges C, Hardy A, Vervoort T, Amouyel T, Duriez P, Lalanne C, Szymanski C, Deken V, Chantelot C, Upex P, Maynou C. Arthroscopic Bankart Repair Versus Immobilization for First Episode of Anterior Shoulder Dislocation Before the Age of 25: A Randomized Controlled Trial. Am J Sports Med. 2021 Apr;49(5):1166-1174. doi: 10.1177/0363546521996381. Epub 2021 Mar 11.

  PMID: 33705240 RESULT

• Pouges C, Boutry M, Maynou C, Chantelot C, Vervoort T, Amouyel T, Lalanne C, Malandri-Ghipponi P. Arthroscopic Bankart Repair Versus Immobilization for a First Episode of an Anterior Shoulder Dislocation Before the Age of 25 Years: A Randomized Controlled Trial With 6-Year Follow-up. Am J Sports Med. 2025 Aug;53(10):2289-2297. doi: 10.1177/03635465251350151. Epub 2025 Jul 2.

  PMID: 40605377 DERIVED

MeSH Terms

Conditions

Bankart Lesions; Shoulder Dislocation

Condition Hierarchy (Ancestors)

Shoulder Fractures; Fractures, Bone; Wounds and Injuries; Shoulder Injuries; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases

Study Officials

• Cécile Pougès, Dr

  CHRU LILLE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: October 20, 2017
• Study Start: March 27, 2014
• Primary Completion: March 26, 2019
• Study Completion: March 26, 2019
• Last Updated: December 22, 2025

Record last verified: 2019-02

Locations

FR (1)