Clinical and Radiographic Outcomes in Arthroscopic Cuistow Procedure and Arthroscopic Modified Bristow Procedure
1 other identifier
observational
70
1 country
1
Brief Summary
To evaluate the clinical and radiographic outcomes of arthroscopic Chinese Unique Inlay Bristow procedure (Cuistow procedure) and arthroscopic Bristow procedure in treating recurrent anterior shoulder instability.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2021
CompletedFirst Submitted
Initial submission to the registry
November 23, 2021
CompletedFirst Posted
Study publicly available on registry
December 7, 2021
CompletedDecember 7, 2021
November 1, 2021
1.2 years
November 23, 2021
November 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
3-month postoperatily
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.
2-year postoperatily
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.
2-year postoperatively
Secondary Outcomes (3)
dislocation rate
2-year postoperatively
VAS for pain score
2-year postoperatively
Active shoulder ranges of motion
2-year postoperatively
Study Arms (2)
Inlay Bristow Group
Inlay Bristow procedure
Onlay Bristow Group
Onlay Bristow procedure
Interventions
Traditional Bristow procedure
Eligibility Criteria
all patients undergoing the Cuistow procedure and modified Bristow procedure in our hospital between Jan 2017 and Mar 2018.
You may qualify if:
- 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.
You may not qualify if:
- multidirectional shoulder instability (MDI),
- uncontrolled epilepsy
- pathological involvement of other soft tissue such as the long head of the biceps or a rotator cuff tear
- previous shoulder stability surgery other than Bankart repair
- Follow-up was less than 2 years or incomplete follow-up data.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PekingUTH
Beijing, Beijing Municipality, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2021
First Posted
December 7, 2021
Study Start
January 17, 2017
Primary Completion
March 20, 2018
Study Completion
November 1, 2021
Last Updated
December 7, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share