Dynamic Anterior Stabilization With Transsubscapular Long Head of the Biceps
Primary Purpose
Anterior Shoulder Dislocation, Bankart Lesion, Hill Sachs Lesion
Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Dynamic Anterior Stabilization
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Shoulder Dislocation focused on measuring Transsubscapular, Long head of the biceps tendon, LHBT, Anterior Shoulder Dislocation, Bankart, HillSachs, Arthroscopic Anterior Dynamic Stabilization
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
Sites / Locations
- Centro Hospitalar de Lisboa Ocidental
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dynamic Anterior Stabilization
Arm Description
Arthroscopic Dynamic Anterior Capsular Stabilization with Trans subscapular Long Head of the Biceps Tenodesis
Outcomes
Primary Outcome Measures
Shoulder range of motion (ROM)
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
Shoulder Strength
minimum 0 - maximum 25 kilograms, measured using a digital dynamometer; for every scale range provided, higher values represent a better outcome.
The ROWE score
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.
The Western Ontario Shoulder Instability Index (WOSI)
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.
Full Information
NCT ID
NCT03693716
First Posted
September 30, 2018
Last Updated
February 27, 2023
Sponsor
Hospital de Egas Moniz
Collaborators
Centro Hospitalar Lisboa Ocidental
1. Study Identification
Unique Protocol Identification Number
NCT03693716
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 20, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Egas Moniz
Collaborators
Centro Hospitalar Lisboa Ocidental
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dynamic Anterior Stabilization
Arm Type
Experimental
Arm Description
Arthroscopic Dynamic Anterior Capsular Stabilization with Trans subscapular Long Head of the Biceps Tenodesis
Intervention Type
Procedure
Intervention Name(s)
Dynamic Anterior Stabilization
Intervention Description
All-arthroscopic trans subscapular Long Head of the Biceps tenodesis in the anterior-inferior glenoid with all-suture anchors
Primary Outcome Measure Information:
Title
Shoulder range of motion (ROM)
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Shoulder Strength
Description
minimum 0 - maximum 25 kilograms, measured using a digital dynamometer; for every scale range provided, higher values represent a better outcome.
Time Frame
2 years
Title
The ROWE score
Description
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.
Time Frame
2 years
Title
The Western Ontario Shoulder Instability Index (WOSI)
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clara Azevedo, MD
Organizational Affiliation
Centro Hospitalar de Lisboa Ocidental
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Hospitalar de Lisboa Ocidental
City
Lisboa
ZIP/Postal Code
1700-348
Country
Portugal
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
624747
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.
Results Reference
result
PubMed Identifier
9850776
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.
Results Reference
result
PubMed Identifier
33599463
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.
Results Reference
derived
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Dynamic Anterior Stabilization With Transsubscapular Long Head of the Biceps
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