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Clinical and Radiographic Outcomes in Arthroscopic Cuistow Procedure and Arthroscopic Modified Bristow Procedure

NCT ID: NCT05146791

Last Updated: 2021-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-17

Study Completion Date

2021-11-01

Brief Summary

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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.

Detailed Description

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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 study, patients received Cuistow procedure have satisfying clinical performance and excellent postoperative bone healing rate (96.1%). However, no comparative studies was performed.

Study Design: Retrospective comparative case-cohort study

Methods: Patients who underwent the arthroscopic Cuisotw procedure and modified Bristow procedure between Jan 2017 and Mar 2018 were selected. 70 patients with recurrent anterior shoulder instability were included. 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.

Conditions

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Shoulder Dislocation

Keywords

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Bristow shoulder dislocation Inlay

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Inlay Bristow Group

Inlay Bristow procedure

Inlay Bristow

Intervention Type PROCEDURE

A modified Bristow procedure

Onlay Bristow Group

Onlay Bristow procedure

Bristow

Intervention Type PROCEDURE

Traditional Bristow procedure

Interventions

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Inlay Bristow

A modified Bristow procedure

Intervention Type PROCEDURE

Bristow

Traditional Bristow procedure

Intervention Type PROCEDURE

Other Intervention Names

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Cuistow Modified Bristow procedure

Eligibility Criteria

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Inclusion Criteria

1. a glenoid defect ≥10% but \<25%,
2. participation in high-demand (collision and overhead) sports combined with the presence of a glenoid defect \<25% of the glenoid or without defect
3. failure after Bankart repair.

Exclusion Criteria

1. multidirectional shoulder instability (MDI),
2. uncontrolled epilepsy
3. pathological involvement of other soft tissue such as the long head of the biceps or a rotator cuff tear
4. previous shoulder stability surgery other than Bankart repair
5. Follow-up was less than 2 years or incomplete follow-up data.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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PekingUTH

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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M2021039-2

Identifier Type: -

Identifier Source: org_study_id