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

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Dislocation
• Intervention / Treatment: Procedure: Inlay Bristow; Procedure: Bristow

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 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.

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • PekingUTH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

all patients undergoing the Cuistow procedure and modified Bristow procedure in our hospital between Jan 2017 and Mar 2018.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Inlay Bristow Group; Inlay Bristow procedure	Procedure: Inlay Bristow; A modified Bristow procedure; Other Names: Cuistow
Onlay Bristow Group; Onlay Bristow procedure	Procedure: Bristow; Traditional Bristow procedure; Other Names: Modified Bristow procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
dislocation rate	The dislocation rate was obtained by dividing the number of people who dislocated postopratively by the total number of people.	2-year postoperatively
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.	2-year postoperatively
Active shoulder ranges of motion	internal rotation at the side, and external and internal rotation at 90° of abduction	2-year postoperatively

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2017
• Primary Completion (Actual): March 20, 2018
• Study Completion (Actual): November 1, 2021

Study Registration Dates

• First Submitted: November 23, 2021
• First Submitted That Met QC Criteria: November 23, 2021
• First Posted (Actual): December 7, 2021

Study Record Updates

• Last Update Posted (Actual): December 7, 2021
• Last Update Submitted That Met QC Criteria: November 23, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Bristow; shoulder dislocation; Inlay
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Joint Dislocations; Shoulder Dislocation
• Other Study ID Numbers: M2021039-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No