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

P

Peking University

Status

Enrolling

Conditions

Joint Hypermobility
Ankle Sprains
Instability, Joint

Treatments

Procedure: Modified Broström operation and anatomic reconstruction operation

Study type

Observational

Funder types

Other

Identifiers

NCT05196906
M2021565

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated 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

100 participants in 2 patient groups

Modified Broström operation group
Description:
Patients who accept a modified Broström operation
Treatment:
Procedure: Modified Broström operation and anatomic reconstruction operation
Anatomic reconstruction operation group
Description:
Patients who accept an anatomic reconstruction
Treatment:
Procedure: Modified Broström operation and anatomic reconstruction operation

Trial contacts and locations

1

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Central trial contact

Dong Jiang, MD; Anhong Wang, MD

Data sourced from clinicaltrials.gov

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