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

Not Applicable
Completed
Conditions
Ankle Sprains
Instability, Joint
Joint Hypermobility
Interventions
Procedure: Open or arthroscopic Modified Broström operation
Registration Number
NCT05284188
Lead Sponsor
Peking University Third Hospital
Brief 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
74
Inclusion Criteria
  • Clinical diagnosis of lateral ankle pain and instability Beighton score ≥4 Age with 18 to 60 years
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Exclusion Criteria
  • Patients with an acute or subacute ankle injury (within 3 months) Injury of the deltoid ligament Alignment of lower extremity greater than 5 degrees Fractures of the lower extremity Stage III or IV osteoarthritis Patients who refused to participate in the study
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Open Modified Broström operation groupOpen or arthroscopic Modified Broström operationPatients who accept an open modified Broström operation
Arthroscopic Modified Broström operation groupOpen or arthroscopic Modified Broström operationPatients who accept an arthroscopic modified Broström operation
Primary Outcome Measures
NameTimeMethod
Karlsson scorepostoperative Karlsson score at 2 years

This score is a primary scale for lateral ankle instability

Secondary Outcome Measures
NameTimeMethod
Anterior displacement and talar tilt angle in stress radiographypostoperative radiographic measures at 2 years

The outcomes are common indicators for evaluation the lateral stability of ankle

Trial Locations

Locations (1)

Peking University Third Hospital

🇨🇳

Beijing, China

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