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Dynamic Anterior Stabilization With Transsubscapular Long Head of the Biceps

H

Hospital de Egas Moniz

Status

Completed

Conditions

Anterior Shoulder Dislocation
Bankart Lesion
Hill Sachs Lesion

Treatments

Procedure: Dynamic Anterior Stabilization

Study type

Interventional

Funder types

Other

Identifiers

NCT03693716
01-2018-09HSFX

Details and patient eligibility

About

Clinical study of patients with a history of traumatic anterior shoulder dislocations to test the hypothesis that the arthroscopic dynamic anterior capsular stabilization technique with trans subscapular long head of the biceps tenodesis produces progressive good clinical and imagiological results.

Full description

Patients with a history of traumatic anterior shoulder dislocations with documented imagological Bankart and HillSachs lesions who meet the eligibility criteria will be enrolled in the study and undergo an arthroscopic dynamic anterior capsular stabilization technique with trans subscapular long head of the biceps tenodesis. All patients will be clinically and radiologically/imagiologically assessed preoperatively and at the 6-months, 12-months and 2-years postoperative evaluations. The range of motion (ROM), shoulder abduction strength, Constant, ROWE and WOSI scores will be compared from preoperative to 6 months postoperative; from 6 months postoperative to 12 months postoperative; and from 12 months to 2 years postoperative (paired-samples t-test, two-tailed). All continuous variables will be compared between the group of patients with failures (a failure is defined as a patient who suffers an objective re-dislocation episode during the 2-year follow-up) and the group without failures (Mann-Whitney U test). All categorical variables and outcome results will be compared between the two groups (Fisher's exact test). A significant difference will be defined as P<0.05.

Enrollment

18 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Bankart lesion and Hill Sachs lesions on the magnetic resonance imaging
  • one or more traumatic anterior shoulder dislocation episodes
  • contact or forced overhead sport or work activity

Exclusion criteria

  • proximal humerus fracture
  • rotator cuff tear requiring repair

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

18 participants in 1 patient group

Dynamic Anterior Stabilization
Experimental group
Description:
Arthroscopic Dynamic Anterior Capsular Stabilization with Trans subscapular Long Head of the Biceps Tenodesis
Treatment:
Procedure: Dynamic Anterior Stabilization

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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