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Completed

NCT Number: NCT04949217

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

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

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inlay Bristow

Procedure

A modified Bristow procedure

Other names: Cuistow

Bristow

Procedure

Traditional Bristow procedure

Primary outcomes

  1. Bone union rate

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. dislocation rate

    Time frame: 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

    Time frame: 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

    Time frame: 2-year postoperatively

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

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2021
First posted
Jul 2, 2021
Registry last updated
Jul 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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