NCT05196906

The Clinical Outcomes of the Modified Broström vs Anatomic Reconstruction Operation in CLAI and GJL

The Clinical Outcomes Comparing the Modified Broström vs Anatomic Reconstruction Operation in Chronic Lateral Ankle Instability and Generalized Joint Laxity

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Investigators designed this prospective cohort study to compare the clinical outcomes of modified Broström operation and anatomical reconstruction for the treatment of CLAI and GJL.

Detailed description

The modified Broström operation is still the first line to treat chronic lateral ligament instability (CLAI). However, some studies indicate the modified Broström operation may bring a higher rate of re-injury in generalized joint laxity (GJL). Anatomical reconstruction was reported to generate similar results and less rate of re-injury compared in patients with CLAI. However, the clinical outcomes of the two operations are not discussed in CLAI and GJL. So, investigators designed this prospective cohort study. The primary outcomes are Karlsson, Foot and Ankle Outcome Score (FAOS), and Foot and Ankle Ability Measure (FAAM) scores. 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	Modified Broström operation and anatomic reconstruction operation	Patients with CLAI and GJL will accept the Modified Broström operation or anatomic reconstruction operation.

Timeline

• Start date: 2020-01-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2022-01-19
• Last updated: 2025-04-11

Locations

1 site across 1 country: China