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

Sponsor
Peking University Third Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04460118
Collaborator
(none)
117
1
19
6.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Bristow surgery fixed by the screw
  • Procedure: Bristow surgery fixed by the suture button

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 Design

Study Type:
Observational
Actual Enrollment :
117 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Clinical and Radiographic Outcomes in Arthroscopic "Inlay"Bristow Surgery With Screw Fixation vs Suture-button Fixation
Actual Study Start Date :
Sep 1, 2018
Actual Primary Completion Date :
Sep 1, 2019
Actual Study Completion Date :
Apr 1, 2020

Arms and Interventions

Arm Intervention/Treatment
screw group

coracoid bone block fixed by the screw

Procedure: Bristow surgery fixed by the screw
Bristow surgery fixed by the screw

button group

coracoid bone block fixed by the suture-button

Procedure: Bristow surgery fixed by the suture button
Bristow surgery fixed by the suture button

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. Active shoulder ranges of motion [2 years after surgery]

    internal rotation at the side, and external and internal rotation at 90° of abduction,

  2. 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.

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. a glenoid defect ≥10%

  2. contact sport athletes with a glenoid defect < 10%

  3. failure after Bankart repair.

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 PekingUTH Beijing Beijing China

Sponsors and Collaborators

  • Peking University Third Hospital

Investigators

  • Principal Investigator: Guoqing Cui, professor, Peking University Third Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking University Third Hospital
ClinicalTrials.gov Identifier:
NCT04460118
Other Study ID Numbers:
  • cui1
First Posted:
Jul 7, 2020
Last Update Posted:
Jul 7, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 7, 2020