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Clinical Trials/NCT04460118
NCT04460118
Completed
Not Applicable

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

Peking University Third Hospital1 site in 1 country117 target enrollmentSeptember 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Shoulder; Dislocation, Chronic
Sponsor
Peking University Third Hospital
Enrollment
117
Locations
1
Primary Endpoint
VAS for pain score
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2018
End Date
April 1, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • a glenoid defect ≥10%
  • contact sport athletes with a glenoid defect \< 10%
  • failure after Bankart repair.

Exclusion Criteria

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

Outcomes

Primary Outcomes

VAS for pain score

Time Frame: 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

Time Frame: 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 Outcomes

  • Active shoulder ranges of motion(2 years after surgery)
  • Bone union(3 months after surgery, 6 months after surgery, 1 year after surgery and 2 years after surgery)
  • Bone block position(immediately after surgery.)

Study Sites (1)

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