Dynamic Anterior Stabilization With Transsubscapular Long Head of the Biceps

Not Applicable

Completed

• Conditions: Hill Sachs Lesion; Bankart Lesion; Anterior Shoulder Dislocation
• Interventions: Procedure: Dynamic Anterior Stabilization

• Registration Number: NCT03693716
• Lead Sponsor: Hospital de Egas Moniz

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2018-09-20
• Study First Submitted: 2018-09-30
• Study First Submitted QC: 2018-10-01
• Study First Posted: 2018-10-03
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dynamic Anterior Stabilization	Dynamic Anterior Stabilization	Arthroscopic Dynamic Anterior Capsular Stabilization with Trans subscapular Long Head of the Biceps Tenodesis

Primary Outcome Measures

Name	Time	Method
Shoulder range of motion (ROM)	2 years	Bilateral shoulder active range of motion (ROM): elevation (0 -180º), abduction (0 -180º) and external rotation (0 -100º), measured in degrees ; and internal rotation, defined as the highest vertebral body that the patient's thumb can reach, converted afterwards to a scale of 1-5 points: lateral thigh=0; buttock=1; sacrum=2; lumbar=3; 12th thoracic vertebra=4; 7th thoracic vertebra=5; for every scale range provided, higher values represent a better outcome.

Secondary Outcome Measures

Name	Time	Method
Shoulder Strength	2 years	minimum 0 - maximum 25 kilograms, measured using a digital dynamometer; for every scale range provided, higher values represent a better outcome.
The Western Ontario Shoulder Instability Index (WOSI)	2 years	0-2100 (0-100%), the WOSI score instrument (Kirkley et al. 1998) consists of 21 items. The patient is asked to grade the function of a specific item on a horizontal visual analog scale from 0 to 100; for every scale range provided, higher values represent a worse outcome.
The ROWE score	2 years	0 -100 points: Section 1 - Stability No Recurrence, subluxation or apprehension (50 points) Apprehension when placing arm in certain positions (30 points) Subluxation (not requiring reduction) (10 points) Recurrent Dislocation (0 points); Section 2 - Motion 100% of normal ext rotation, int rotation and elevation (20 points) 75% of normal ext rotation, int rotation and elevation (15 points) 50% of normal ext rotation, int rotation and elevation (5 points) 50% of normal elevation, and int rotation, No ext rotation (0 points); Section 3 - Function No limitation of work or sports, little or no discomfort (eg shoulder strong overhead, lifting, swimming, throwing, tennis) (30 points); Mild limitation and minimum discomfort (25 points) Moderate limitation and discomfort (10 points) Marked limitation and pain (0 points) For every scale range provided, higher values represent a better outcome.

Trial Locations

Locations (1)

Centro Hospitalar de Lisboa Ocidental; 🇵🇹 Lisboa, Portugal