An Exploratory Randomized Controlled Study of Arthroscopic Inlay Bristow Procedure for Recurrent Anterior Shoulder Dislocation

Sponsor
Peking University Third Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04949217
Collaborator
(none)
70
2
52.4

Study Details

Study Description

Brief Summary

To evaluate the clinical and radiographic outcomes of arthroscopic inlay bristow procedure in treating recurrent anterior shoulder instability.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Inlay Bristow
  • Procedure: Bristow
N/A

Detailed Description

Aim: To compare the clinical and radiographic outcomes following the arthroscopic Chinese Unique Inlay Bristow (Cuistow) procedure and the arthroscopic Bristow procedure.

Background: The Cuistow procedure is a modified Bristow surgery in which a Mortise and Tenon structure was added to the contact surface between the coracoid tip and the glenoid. In previous retrospective study, patients received Cuistow procedure have satisfying clinical performance and excellent postoperative bone healing rate (96.1%). However, no prospective randomized controlled trial was performed.

Methods: 70 patients with recurrent anterior shoulder instability were included and randomized to either an arthroscopic Cuistow procedure or arthroscopic Bristow procedure. Radiological evaluations with 3D CT scan were performed preoperatively, immediately after the operation, and postoperatively at three months and during the final follow-up (more than 2 years). Clinical assessment for a minimum of 24 months including the 10-point visual analog scale for pain and subjective instability, University of California at Los Angeles scoring system (UCLA score), American Shoulder and Elbow Surgeons score (ASES score), ROWE score, Subjective Shoulder Value (SSV) and active range of motion were completed by independent observers and analyzed.

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Exploratory Randomized Controlled Study of Arthroscopic Inlay Bristow Procedure for Recurrent Anterior Shoulder Dislocation
Actual Study Start Date :
Jan 17, 2017
Actual Primary Completion Date :
Mar 20, 2018
Actual Study Completion Date :
May 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Inlay Bristow Group

Inlay Bristow procedure

Procedure: Inlay Bristow
A modified Bristow procedure
Other Names:
  • Cuistow
  • Active Comparator: Onlay Bristow Group

    Onlay Bristow procedure

    Procedure: Bristow
    Traditional Bristow procedure

    Outcome Measures

    Primary Outcome Measures

    1. Bone union rate [3-month postoperatily]

      Bone healing was observed in 3D-CT. The bone healing rate was obtained by dividing the number of people who achieved bone healing by the total number of people

    2. Bone union rate [2-year postoperatively]

      Bone healing was observed in 3DCT. The bone healing rate was obtained by dividing the number of people who achieved bone healing by the total number of people

    3. ASES score [2-year postoperatively]

      The ASES score (Michener 2002) is a 10-item measure of shoulder pain and function. Pain is assessed on a 10-cm visual analog scale (VAS) and accounts for 50% of the total score. The remaining 50% of the score is determined by the responses to 10 4-point Likert-scale questions related to physical function.

    Secondary Outcome Measures

    1. dislocation rate [2-year postoperatively]

      The dislocation rate was obtained by dividing the number of people who dislocated postopratively by the total number of people

    2. VAS for pain score [2-year postoperatively]

      The visual analog scale (VAS) for pain score is the most commonly used to describe pain levels in patients, ranging from 0 to 10, with a higher score indicating more intense pain.

    3. Active shoulder ranges of motion [2-year postoperatively]

      internal rotation at the side, and external and internal rotation at 90° of abduction

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Recurrent anterior shoulder instability based on medical history, physical examination, and radiological results.

    • A glenoid defect ≥10% but <25%

    • Participation in high-demand (collision and overhead) sports combined with the presence of a glenoid defect <25% of the glenoid or without defect

    • Failure after Bankart repair

    Exclusion Criteria:
    • Multi-directional shoulder instability

    • Uncontrolled epilepsy

    • History of receiving Bristow-Latarjet procedure.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Peking University Third Hospital

    Investigators

    • Study Chair: Guoqing Cui, Peking University Third Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peking University Third Hospital
    ClinicalTrials.gov Identifier:
    NCT04949217
    Other Study ID Numbers:
    • M2021039
    First Posted:
    Jul 2, 2021
    Last Update Posted:
    Jul 13, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Peking University Third Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 13, 2021