NCT05284188

The Clinical Outcomes of the Arthroscopic and Open Modified Broström Operation in CLAI and GJL

The Clinical Outcomes Comparing Open and Arthroscopic Modified Broström Operation in Chronic Lateral Ankle Instability and Generalized Joint Laxity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Investigators designed this randomized controlled trial to compare the clinical outcomes of open and arthroscopic modified Broström operation for the treatment of CLAI and GJL.

Detailed description

The open modified Broström operation is the first line to treat chronic lateral ligament instability (CLAI). Arthroscopic techniques gain popularity for less invasivity, quick recovery to normal and sports activities, and the possibility to treat other intraarticular disorders. Studies have shown significantly poor clinical and radiological outcomes and a higher rate of failure in patients with generalized joint laxity (GJL) than patients without after open modified Broström operation. However, there is no study to compare the open and arthroscopic modified Brostrom operation for patients with GJL and CLAI. So, investigators designed this randomized controlled trial. The primary outcomes are Karlsson, American Orthopaedic Foot \& Ankle Society, and visual analogue scales. The secondary outcomes are anterior displacement and talar tilt angle in stress radiography, the rate of re-injury.

Conditions

• Ankle Sprains
• Instability, Joint
• Joint Hypermobility

Interventions

Type	Name	Description
PROCEDURE	Open or arthroscopic Modified Broström operation	Patients with CLAI and GJL were randomly allocated to accept the open or arthroscopic Modified Broström operation.

Timeline

• Start date: 2018-01-08
• Primary completion: 2020-12-01
• Completion: 2021-12-01
• First posted: 2022-03-17
• Last updated: 2022-06-27

Locations

1 site across 1 country: China