Clinical trial NCT03693716: Dynamic Anterior Stabilization With Transsubscapular Long Head of the Biceps
Official title: Arthroscopic Dynamic Anterior Capsular Stabilization With Trans Subscapular Long Head of the Biceps Tenodesis in Anterior Shoulder Instability - Clinical and Imagiological Results
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Shoulder Dislocation
Bankart Lesion
Hill Sachs Lesion
Keywords: Transsubscapular
Long head of the biceps tendon
LHBT
Anterior Shoulder Dislocation
Bankart
HillSachs
Arthroscopic Anterior Dynamic Stabilization
Lead sponsor: Hospital de Egas Moniz
Sponsor class: OTHER
Collaborators: name: Centro Hospitalar Lisboa Ocidental
First posted: 2018-10-03
Enrollment: 18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Shoulder range of motion (ROM)
timeFrame: 2 years
Secondary outcomes:
measure: Shoulder Strength
timeFrame: 2 years
measure: The ROWE score
timeFrame: 2 years
measure: The Western Ontario Shoulder Instability Index (WOSI)
timeFrame: 2 years
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Ocidental
Study officials:
affiliation: Centro Hospitalar de Lisboa Ocidental
name: Clara Azevedo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rowe CR, Patel D, Southmayd WW. The Bankart procedure: a long-term end-result study. J Bone Joint Surg Am. 1978 Jan;60(1):1-16.
citation: Kirkley A, Griffin S, McLintock H, Ng L. The development and evaluation of a disease-specific quality of life measurement tool for shoulder instability. The Western Ontario Shoulder Instability Index (WOSI). Am J Sports Med. 1998 Nov-Dec;26(6):764-72. doi: 10.1177/03635465980260060501.
citation: de Campos Azevedo C, Angelo AC. All-Suture Anchor Dynamic Anterior Stabilization Produced Successful Healing of the Biceps Tendon: A Report of 3 Cases. JBJS Case Connect. 2021 Feb 17;11(1). doi: 10.2106/JBJS.CC.20.00149.