Clinical trial NCT03315819: Anterior Capsulo-labral Reinsertion by Arthroscopic Approach Versus Immobilization
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 "
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bankart Lesion
Keywords: glenohumeral dislocation
Arthroscopic
capsular lesions
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2017-10-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of occurrence of a recurrence during the follow-up period of 2 years
timeFrame: at 2 years
Secondary outcomes:
measure: Number of recidivism of dislocation with the necessity of reduction by a third person
timeFrame: at 3 months, 6 months, 1 years and 2 years
measure: number of episodes of subluxations reported by the patient at the interview
timeFrame: at 3 months, 6 months, 1 years and 2 years
measure: Goniometer measurement of the angle in the ankle joint
timeFrame: at 3 months, 6 months, 1 years and 2 years
measure: Walch Duplay Score
timeFrame: at 3 months, 6 months, 1 years and 2 years
measure: Disabilities of the Arm, Shoulder and Hand (DASH) Score
timeFrame: at 3 months, 6 months, 1 years and 2 years
measure: Western Ontario Shoulder Instability (WOSI) Score.
timeFrame: at 3 months, 6 months, 1 years and 2 years
measure: Likert Scale
timeFrame: at 2 years
measure: The duration of work stoppage
timeFrame: at 2 years
measure: Time lapse - resumption of sports activities and level of sport practiced
timeFrame: At 6 months, 1 years and 2 years
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Roger Salengro
Study officials:
affiliation: CHRU LILLE
name: Cécile Pougès, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.