Dynamic Anterior Stabilization With Transsubscapular Long Head of the Biceps

NCT ID: NCT03693716

Last Updated: 2023-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-20

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Anterior Shoulder Dislocation Bankart Lesion Hill Sachs Lesion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dynamic Anterior Stabilization

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

Group Type EXPERIMENTAL

Dynamic Anterior Stabilization

Intervention Type PROCEDURE

All-arthroscopic trans subscapular Long Head of the Biceps tenodesis in the anterior-inferior glenoid with all-suture anchors

Interventions

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Dynamic Anterior Stabilization

All-arthroscopic trans subscapular Long Head of the Biceps tenodesis in the anterior-inferior glenoid with all-suture anchors

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro Hospitalar Lisboa Ocidental

OTHER_GOV

Sponsor Role collaborator

Hospital de Egas Moniz

OTHER

Sponsor Role lead

Responsible Party

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Clara Isabel de Campos Azevedo

Shoulder Surgery Unit Coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Clara Azevedo, MD

Role: PRINCIPAL_INVESTIGATOR

Centro Hospitalar de Lisboa Ocidental

Locations

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Centro Hospitalar de Lisboa Ocidental

Lisbon, , Portugal

Site Status

Countries

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Portugal

References

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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.

Reference Type RESULT
PMID: 624747 (View on PubMed)

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.

Reference Type RESULT
PMID: 9850776 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33599463 (View on PubMed)

Other Identifiers

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01-2018-09HSFX

Identifier Type: -

Identifier Source: org_study_id

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