Clinical and Radiographic Outcomes in Arthroscopic "Inlay"Bristow Surgery With Screw Fixation vs Suture-button Fixation

Completed

• Conditions: Shoulder; Dislocation, Chronic
• Interventions: Procedure: Bristow surgery fixed by the screw; Procedure: Bristow surgery fixed by the suture button

• Registration Number: NCT04460118
• Lead Sponsor: Peking University Third Hospital

Brief Summary

Retrospective comparative case-cohort study to investigate the efficacy of the modified arthroscopic Bristow-Latarjet surgery and to compare the clinical and radiographic outcomes using screw fixation vs suture-button fixation.

Detailed Description

Background：Some studies have advocated the use of suture-button fixation during Bristow-latarjet surgery to reduce complications associated with screw fixation. However, these studies are not comparative studies, and their data are relatively incomplete.

Purpose: To compare the clinical and radiographic outcomes using screw fixation vs suture-button fixation.

Study Design: Retrospective comparative case-cohort study Methods: Patients who underwent the modified arthroscopic Bristow-Latarjet surgery between June 2015 and February 2018 were selected. Shoulders were separated into two groups based on surgical fixation method. Radiological results on 3D CT scan and clinical results were assessed preoperatively, immediately after operation, and postoperatively at 3 months, 6 months, 1 year and during the final follow-up.

Study Timeline

• Study Start: 2018-09-01
• Primary Completion: 2019-09-01
• Study Completion: 2020-04-01
• Status Verified: 2020-06
• Study First Submitted: 2020-06-30
• Study First Submitted QC: 2020-07-04
• Last Update Submitted: 2020-07-04
• Study First Posted: 2020-07-07
• Last Update Posted: 2020-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

Inclusion Criteria

1. a glenoid defect ≥10%
2. contact sport athletes with a glenoid defect < 10%
3. failure after Bankart repair.

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Exclusion Criteria

1. epilepsy
2. multidirectional shoulder instability
3. concomitant other lesions including rotator cuff tear, symptomatic acromioclavicular joint pathology or pathological involvement of the long head of the biceps
4. Follow-up was less than 2 years or incomplete follow-up data.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
screw group	Bristow surgery fixed by the screw	coracoid bone block fixed by the screw
button group	Bristow surgery fixed by the suture button	coracoid bone block fixed by the suture-button

Primary Outcome Measures

Name	Time	Method
VAS for pain score	2 years after surgery	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.
ASES score	2 years after surgery	The American Shoulder and Elbow Surgeons (ASES) score is the most commonly used score to describe the function of patients' shoulder joints, ranging from 0 to 100. The higher the score, the better the function of patients' shoulder joints.

Secondary Outcome Measures

Name	Time	Method
Active shoulder ranges of motion	2 years after surgery	internal rotation at the side, and external and internal rotation at 90° of abduction,
Bone union	3 months after surgery, 6 months after surgery, 1 year after surgery and 2 years after surgery	Graft union with the glenoid was assessed using postoperative CT scans. ''Bony union'' of the transplant was defined as no radiolucent zone; ''fibrous union,'' when the transplant had a radiolucent zone of less than 5 mm; and ''migration,'' when the zone was 5 mm or more.
Bone block position	immediately after surgery.	Bone block position was evaluated using postoperative CT scans.The ideal position of the bone block was defined as flush to the anterior glenoid rim in the axial view and 4 o'clock in the En face view. The bone block was considered too lateral if it went beyond the glenoid rim by more than 5 mm and it was judged to be too medial if it was medial to the rim by more than 5 mm.

Trial Locations

Locations (1)

PekingUTH; 🇨🇳 Beijing, Beijing, China