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

P

Peking University

Status

Completed

Conditions

Joint Hypermobility
Ankle Sprains
Instability, Joint

Treatments

Procedure: Open or arthroscopic Modified Broström operation

Study type

Interventional

Funder types

Other

Identifiers

NCT05284188
M2021052

Details and patient eligibility

About

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.

Full 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.

Enrollment

74 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Clinical diagnosis of lateral ankle pain and instability Beighton score ≥4 Age with 18 to 60 years

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

74 participants in 2 patient groups

Open Modified Broström operation group
Active Comparator group
Description:
Patients who accept an open modified Broström operation
Treatment:
Procedure: Open or arthroscopic Modified Broström operation
Arthroscopic Modified Broström operation group
Active Comparator group
Description:
Patients who accept an arthroscopic modified Broström operation
Treatment:
Procedure: Open or arthroscopic Modified Broström operation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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