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

Shoulder; Dislocation, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04460118
• Other study ID #: cui1
• Status: Completed
• Start date: September 1, 2018
• Est. completion date: April 1, 2020

Study information

• Verified date: June 2020
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: April 1, 2020
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Shoulder Dislocation
• Shoulder; Dislocation, Chronic

Intervention

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

Locations

Country	Name	City	State
China	PekingUTH	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 years after surgery
Primary	ASES score	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.	2 years after surgery
Secondary	Active shoulder ranges of motion	internal rotation at the side, and external and internal rotation at 90° of abduction,	2 years after surgery
Secondary	Bone block position	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.	immediately after surgery.
Secondary	Bone union	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.	3 months after surgery, 6 months after surgery, 1 year after surgery and 2 years after surgery