An Exploratory Randomized Controlled Study of Arthroscopic Inlay Bristow Procedure for Recurrent Anterior Shoulder Dislocation

Shoulder Dislocation Clinical Trial

Official title:

An Exploratory Randomized Controlled Study of Arthroscopic Inlay Bristow Procedure for Recurrent Anterior Shoulder Dislocation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04949217
• Other study ID #: M2021039
• Status: Completed
• Phase: N/A
• Start date: January 17, 2017
• Est. completion date: May 31, 2021

Study information

• Verified date: July 2021
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the clinical and radiographic outcomes of arthroscopic inlay bristow procedure in treating recurrent anterior shoulder instability.

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 retrospective study, patients received Cuistow procedure have satisfying clinical performance and excellent postoperative bone healing rate (96.1%). However, no prospective randomized controlled trial was performed.

Methods: 70 patients with recurrent anterior shoulder instability were included and randomized to either an arthroscopic Cuistow procedure or arthroscopic Bristow procedure. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 31, 2021
• Est. primary completion date: March 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Recurrent anterior shoulder instability based on medical history, physical examination, and radiological results.

• A glenoid defect =10% but <25%

• Participation in high-demand (collision and overhead) sports combined with the presence of a glenoid defect <25% of the glenoid or without defect

• Failure after Bankart repair

Exclusion Criteria:

• Multi-directional shoulder instability

• Uncontrolled epilepsy

• History of receiving Bristow-Latarjet procedure.

Related Conditions & MeSH terms

• Shoulder Dislocation

Intervention

Procedure:
• Inlay Bristow
A modified Bristow procedure
• Bristow
Traditional Bristow procedure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Bone union rate	Bone healing was observed in 3DCT. The bone healing rate was obtained by dividing the number of people who achieved bone healing by the total number of people	2-year postoperatively
Primary	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	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
Secondary	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
Secondary	Active shoulder ranges of motion	internal rotation at the side, and external and internal rotation at 90° of abduction	2-year postoperatively