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Completed

NCT Number: NCT05284188

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

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.

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Key information

Conditions

Ankle Sprains Ankle Injuries Instability, Joint Joint Diseases Joint Hypermobility Joint Instability Leg Injuries Musculoskeletal Diseases Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Third Hospital

Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Open or arthroscopic Modified Broström operation

Procedure

Patients with CLAI and GJL were randomly allocated to accept the open or arthroscopic Modified Broström operation.

Primary outcomes

  1. Karlsson score

    Time frame: postoperative Karlsson score at 1 year

    This score is a primary scale for lateral ankle instability

  2. Karlsson score

    Time frame: postoperative Karlsson score at 2 years

    This score is a primary scale for lateral ankle instability

Secondary outcomes

  1. Anterior displacement and talar tilt angle in stress radiography

    Time frame: postoperative radiographic measures at 2 years

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

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Mar 17, 2022
Registry last updated
Jun 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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