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Dynamic Anterior Stabilization With Transsubscapular Long Head of the Biceps

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ClinicalTrials.gov Identifier: NCT03693716
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : November 14, 2018
Sponsor:
Collaborator:
Centro Hospitalar Lisboa Ocidental
Information provided by (Responsible Party):
Clara Isabel de Campos Azevedo, 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.

Condition or disease Intervention/treatment Phase
Anterior Shoulder Dislocation Bankart Lesion Hill Sachs Lesion Procedure: Dynamic Anterior Stabilization Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Arthroscopic Dynamic Anterior Capsular Stabilization With Trans Subscapular Long Head of the Biceps Tenodesis in Anterior Shoulder Instability - Clinical and Imagiological Results
Actual Study Start Date : September 20, 2018
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dynamic Anterior Stabilization
Arthroscopic Dynamic Anterior Capsular Stabilization with Trans subscapular Long Head of the Biceps Tenodesis
Procedure: Dynamic Anterior Stabilization
All-arthroscopic trans subscapular Long Head of the Biceps tenodesis in the anterior-inferior glenoid with all-suture anchors




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Shoulder Strength [ Time Frame: 2 years ]
    minimum 0 - maximum 25 kilograms, measured using a digital dynamometer; for every scale range provided, higher values represent a better outcome.

  2. The ROWE score [ Time Frame: 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.


  3. The Western Ontario Shoulder Instability Index (WOSI) [ Time Frame: 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03693716


Contacts
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Contact: Clara Azevedo, MD 00351938453848 claracamposazevedo@gmail.com

Locations
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Portugal
Centro Hospitalar de Lisboa Ocidental Recruiting
Lisboa, Portugal, 1700-348
Contact: Clara Azevedo, MD    00351938453848    claracamposazevedo@gmail.com   
Contact: Clara Azevedo    00351938453848    claracamposazevedo@gmail.com   
Sponsors and Collaborators
Hospital de Egas Moniz
Centro Hospitalar Lisboa Ocidental
Investigators
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Principal Investigator: Clara Azevedo, MD Centro Hospitalar de Lisboa Ocidental

Publications of Results:
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Responsible Party: Clara Isabel de Campos Azevedo, Shoulder Surgery Unit Coordinator, Hospital de Egas Moniz
ClinicalTrials.gov Identifier: NCT03693716     History of Changes
Other Study ID Numbers: 01-2018-09HSFX
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clara Isabel de Campos Azevedo, Hospital de Egas Moniz:
Transsubscapular
Long head of the biceps tendon
LHBT
Anterior Shoulder Dislocation
Bankart
HillSachs
Arthroscopic Anterior Dynamic Stabilization
Additional relevant MeSH terms:
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Joint Dislocations
Shoulder Dislocation
Bankart Lesions
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries
Shoulder Injuries
Shoulder Fractures
Fractures, Bone