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Clinical Trials/NCT03693716
NCT03693716
Completed
Not Applicable

Arthroscopic Dynamic Anterior Capsular Stabilization With Trans Subscapular Long Head of the Biceps Tenodesis in Anterior Shoulder Instability - Clinical and Imagiological Results

Hospital de Egas Moniz1 site in 1 country18 target enrollmentSeptember 20, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anterior Shoulder Dislocation
Sponsor
Hospital de Egas Moniz
Enrollment
18
Locations
1
Primary Endpoint
Shoulder range of motion (ROM)
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 20, 2018
End Date
December 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Hospital de Egas Moniz
Responsible Party
Principal Investigator
Principal Investigator

Clara Isabel de Campos Azevedo

Shoulder Surgery Unit Coordinator

Hospital de Egas Moniz

Eligibility Criteria

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

Outcomes

Primary Outcomes

Shoulder range of motion (ROM)

Time Frame: 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 Outcomes

  • Shoulder Strength(2 years)
  • The Western Ontario Shoulder Instability Index (WOSI)(2 years)
  • The ROWE score(2 years)

Study Sites (1)

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