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Trial record 45 of 78 for:    Recruiting, Not yet recruiting, Available Studies | "Bone Transplantation"

The Arthroscopic Treatment of Recurrent Anterior Shoulder Instability (ATRASI)

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ClinicalTrials.gov Identifier: NCT02510625
Recruitment Status : Recruiting
First Posted : July 29, 2015
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):
Ivan Wong, Nova Scotia Health Authority

Brief Summary:

The objective of this study is to investigate arthroscopic treatments of recurrent anterior shoulder instability. Functional outcomes of arthroscopic anatomic glenoid reconstruction with bone graft will be compared to the gold standard, arthroscopic Bankart repair. The investigators hypothesize that arthroscopic anatomic glenoid reconstruction with bone graft will provide better functional outcomes and decreased risk of recurrent dislocation/subluxation.

This will be a single center, double blinded, randomized controlled trial performed in Halifax, Nova Scotia, Canada. The primary outcome measured will be the Western Ontario Shoulder Instability (WOSI) score. Secondary outcomes will be subluxation, re-dislocation, and range of motion. A minimum of 200 patients will be enrolled in the study as determined by sample size calculation. Routine radiographs as well as a pre-operative CT with 3D reconstruction and MRI are obtained for all patients. The patients will then undergo a clinical examination and complete a variety of functional and quality of life surveys. Randomization will be based on surgeon skill. Two groups (Bankart repair and anatomic glenoid reconstruction) will be selected with 100 subjects each. Postoperatively, patients in both groups will follow a standardized rehabilitation protocol. The patient will follow-up with the attending surgeon at 2 weeks post-operatively for a wound check. At the 3, 6, 12, and 24 month visits the patient will again undergo the structured clinical examination conducted by a physiotherapist who is blinded to the patients' treatment group. The patient will also complete the questionnaires at each of these follow-up appointments. Complications, and subluxation/dislocation events will be documented at each follow-up evaluation. On the basis of a clinical examination and patient history, the surgeon will diagnose recurrent instability and categorize it as a traumatic or atraumatic subluxation or dislocation.


Condition or disease Intervention/treatment Phase
Shoulder Dislocation Procedure: Anatomic Glenoid Reconstruction Procedure: Arthroscopic bankart Repair Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Arthroscopic Treatment of Recurrent Anterior Shoulder Instability: A Randomized Controlled Trial
Study Start Date : September 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Bankart repair
Arthroscopic bankart repair
Procedure: Arthroscopic bankart Repair
Arthroscopic bankart Repair

Experimental: Anatomic Glenoid Reconstruction
Arthroscopic distal tibia bone graft
Procedure: Anatomic Glenoid Reconstruction
Distal tibia bone graft
Other Name: Cannulated Bristow-Latarjet Instability Shoulder System (Depuy-Mitek, MA, USA).




Primary Outcome Measures :
  1. WOSI Score [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Recurrent Instability [ Time Frame: 2 years ]
    subluxation/dislocation events will be documented at each follow-up evaluation. On the basis of a clinical examination and patient history, the surgeon will diagnose recurrent instability and categorize it as a traumatic or atraumatic subluxation or dislocation.



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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 2 or more documented incidences of anterior glenohumeral dislocation

Exclusion Criteria:

  • Uncontrolled diabetes (Hgb A1C >7%
  • Prior surgery of affected shoulder
  • Pregnancy
  • Multidirectional instability
  • Posterior instability
  • Paralysis of the shoulder
  • Cancer
  • Severe systemic illness

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): NCT02510625


Contacts
Contact: Nicole Paquet (902)473-7626 research@drivanwong.com

Locations
Canada, Nova Scotia
Nova Scotia Health Authority Recruiting
Halifax, Nova Scotia, Canada, B3H2E1
Contact: Nicole Paquet    (902)473-7626    research@drivanwong.com   
Sponsors and Collaborators
Nova Scotia Health Authority
Investigators
Principal Investigator: Dr. Ivan Wong, MD Dalhousie University

Responsible Party: Ivan Wong, Dr. Ivan Wong, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT02510625     History of Changes
Other Study ID Numbers: 2016-035
First Posted: July 29, 2015    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Shoulder Dislocation
Joint Dislocations
Bone Diseases
Musculoskeletal Diseases
Wounds and Injuries
Shoulder Injuries