An Exploratory Randomized Controlled Study of Arthroscopic Inlay Bristow Procedure for Recurrent Anterior Shoulder Dislocation
Primary Purpose
Shoulder Dislocation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Inlay Bristow
Bristow
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Dislocation focused on measuring bristow, shoulder dislocation
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Inlay Bristow Group
Onlay Bristow Group
Arm Description
Inlay Bristow procedure
Onlay Bristow procedure
Outcomes
Primary Outcome Measures
Bone union rate
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
Bone union rate
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
ASES score
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
dislocation rate
The dislocation rate was obtained by dividing the number of people who dislocated postopratively by the total number of people
VAS for pain score
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.
Active shoulder ranges of motion
internal rotation at the side, and external and internal rotation at 90° of abduction
Full Information
NCT ID
NCT04949217
First Posted
June 25, 2021
Last Updated
July 7, 2021
Sponsor
Peking University Third Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04949217
Brief Title
An Exploratory Randomized Controlled Study of Arthroscopic Inlay Bristow Procedure for Recurrent Anterior Shoulder Dislocation
Official Title
An Exploratory Randomized Controlled Study of Arthroscopic Inlay Bristow Procedure for Recurrent Anterior Shoulder Dislocation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 17, 2017 (Actual)
Primary Completion Date
March 20, 2018 (Actual)
Study Completion Date
May 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the clinical and radiographic outcomes of arthroscopic inlay bristow procedure in treating recurrent anterior shoulder instability.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Dislocation
Keywords
bristow, shoulder dislocation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inlay Bristow Group
Arm Type
Experimental
Arm Description
Inlay Bristow procedure
Arm Title
Onlay Bristow Group
Arm Type
Active Comparator
Arm Description
Onlay Bristow procedure
Intervention Type
Procedure
Intervention Name(s)
Inlay Bristow
Other Intervention Name(s)
Cuistow
Intervention Description
A modified Bristow procedure
Intervention Type
Procedure
Intervention Name(s)
Bristow
Intervention Description
Traditional Bristow procedure
Primary Outcome Measure Information:
Title
Bone union rate
Description
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
Time Frame
3-month postoperatily
Title
Bone union rate
Description
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
Time Frame
2-year postoperatively
Title
ASES score
Description
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.
Time Frame
2-year postoperatively
Secondary Outcome Measure Information:
Title
dislocation rate
Description
The dislocation rate was obtained by dividing the number of people who dislocated postopratively by the total number of people
Time Frame
2-year postoperatively
Title
VAS for pain score
Description
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.
Time Frame
2-year postoperatively
Title
Active shoulder ranges of motion
Description
internal rotation at the side, and external and internal rotation at 90° of abduction
Time Frame
2-year postoperatively
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guoqing Cui
Organizational Affiliation
Peking University Third Hospital
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An Exploratory Randomized Controlled Study of Arthroscopic Inlay Bristow Procedure for Recurrent Anterior Shoulder Dislocation
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