Bankart LesionBANKARTNCT03315819
Anterior Capsulo-labral Reinsertion by Arthroscopic Approach Versus Immobilization
A study testing Bankart repair and Immobilization interne rotation in people with Bankart Lesion, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Bankart Lesion
- What is being tested?
- Bankart repair and Immobilization interne rotation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 27 Mar 2014to 26 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with inclusive on the day of dislocation.
- First episode of anterior glenohumeral dislocation without associated humeral fracture confirmed by a standard radiograph.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: First Episode of Anterior Glenohumeral Dislocation in Adult Patients Under 25 Years of Age: 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.
Read more
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
- Being tested
- Bankart repair, Immobilization interne rotation
- Keywords
- glenohumeral dislocation, Arthroscopic, capsular lesions
- Medical subject headings
- Bankart Lesions, Shoulder Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bankart repairProcedure or surgery
Arthroscopic repair of anterior capsulo-labral lesions using the Bankart technique.
Immobilization interne rotationProcedure or surgery
Immobilisation in rotation Internal (Dujarrier) 3 weeks then rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Bankart repair | Experimental | Arthroscopic repair of anterior capsulo-labral lesions using the Bankart technique. The procedure must be performed within 15 days of dislocation. Receives: Procedure: Bankart repair |
| Immobilization interne rotation | Active comparator | Immobilization of the shoulder during 3 weeks Receives: Procedure: Immobilization interne rotation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of occurrence of a recurrence during the follow-up period of 2 years
Measured: at 2 years
Secondary outcomes (9)
Number of recidivism of dislocation with the necessity of reduction by a third person
Measured: at 3 months, 6 months, 1 years and 2 years
number of episodes of subluxations reported by the patient at the interview
Measured: at 3 months, 6 months, 1 years and 2 years
Goniometer measurement of the angle in the ankle joint
Measured: at 3 months, 6 months, 1 years and 2 years
Walch Duplay Score
Auto questionnaire designed to measure the impact of shoulder instability, activity, pain mobility.total point up to 100 : excellent, good, medium, poor
Measured: at 3 months, 6 months, 1 years and 2 years
Disabilities of the Arm, Shoulder and Hand (DASH) Score
Auto questionnaire designed to measure the quality of life of patients.
Measured: at 3 months, 6 months, 1 years and 2 years
Western Ontario Shoulder Instability (WOSI) Score.
Auto questionnaire designed to measure the impact of shoulder instability on the quality of life of patients. percentage of lifestyle, emotion, physical symptome.
Measured: at 3 months, 6 months, 1 years and 2 years
Likert Scale
Overall patient satisfaction
Measured: at 2 years
The duration of work stoppage
Measured: at 2 years
Time lapse - resumption of sports activities and level of sport practiced
Measured: At 6 months, 1 years and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start27 Mar 2014
- Primary completion26 Mar 2019
- Study completion26 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bankart LesionStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cécile Pougès, Dr, Principal investigator, CHRU LILLE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315819
- Sponsor's protocol ID
- 2013_30
- Other IDs
- 2013-A01720-45
- Acronym
- BANKART
- Status last verified
- Feb 2019
- First submitted
- 16 Oct 2017
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33705240Pouges 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.
PubMed 40605377
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Episode of Anterior Glenohumeral Dislocation in Adult Patients Under 25 Years of Age: Anterior Capsulo-labral Reinsertion by Arthroscopic Approach Versus Immobilization "
- ClinicalTrials.gov ID
- NCT03315819
- Acronym / sponsor ID
- BANKART / 2013_30
- Conditions
- Bankart Lesion
- Keywords
- glenohumeral dislocation, Arthroscopic, capsular lesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 27 Mar 2014 (actual)
- Primary completion
- 26 Mar 2019 (actual)
- Study completion
- 26 Mar 2019 (actual)
- First posted
- 20 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bankart repair | Experimental | Procedure: Bankart repairArthroscopic repair of anterior capsulo-labral lesions using the Bankart technique. The procedure must be performed within 15 days of dislocation. |
| Immobilization interne rotation | Active comparator | Procedure: Immobilization interne rotationImmobilization of the shoulder during 3 weeks |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with inclusive on the day of dislocation.
- First episode of anterior glenohumeral dislocation without associated humeral fracture confirmed by a standard radiograph.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bankart repairArthroscopic repair of anterior capsulo-labral lesions using the Bankart technique. | Procedure or surgery | Bankart repair |
| Immobilization interne rotationImmobilisation in rotation Internal (Dujarrier) 3 weeks then rehabilitation | Procedure or surgery | Immobilization interne rotation |
Primary outcome
Number of occurrence of a recurrence during the follow-up period of 2 years
Time frame: at 2 years
9 secondary outcomes
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
number of episodes of subluxations reported by the patient at the interview
Time frame: at 3 months, 6 months, 1 years and 2 years
Goniometer measurement of the angle in the ankle joint
Time frame: at 3 months, 6 months, 1 years and 2 years
Walch Duplay Score
Time frame: at 3 months, 6 months, 1 years and 2 years
Disabilities of the Arm, Shoulder and Hand (DASH) Score
Time frame: at 3 months, 6 months, 1 years and 2 years
Western Ontario Shoulder Instability (WOSI) Score.
Time frame: at 3 months, 6 months, 1 years and 2 years
Likert Scale
Time frame: at 2 years
The duration of work stoppage
Time frame: at 2 years
Time lapse - resumption of sports activities and level of sport practiced
Time frame: At 6 months, 1 years and 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Results publication: PubMed 33705240Pouges 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.
- Derived from this study: PubMed 40605377Pouges 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cécile Pougès, Dr principal investigator
CHRU LILLE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bankart repair and Immobilization interne rotation in people with Bankart Lesion, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of occurrence of a recurrence during the follow-up period of 2 years (time frame: at 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03315819, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.