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NCT Number: NCT05196906

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

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.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University Third Hospital

Beijing, China

Location status: Recruiting

Location contact

Dong Jiang, MD

CONTACT

[email protected]

13811280948

About this study

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.

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

Modified Broström operation and anatomic reconstruction operation

Procedure

Patients with CLAI and GJL will accept the Modified Broström operation or anatomic reconstruction 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

Other outcomes

  1. Rate of re-injury

    Time frame: the rate of re-injury at 2 years.

    After surgery, the rate of patients re-sprain

  2. Signal to noise value of the anterior talofibular ligament

    Time frame: 6 months post-treatment

    Signal to noise value of the anterior talofibular ligament

  3. Signal to noise value of the anterior talofibular ligament

    Time frame: 12 months post-treatment

    Signal to noise value of the anterior talofibular ligament

  4. Signal to noise value of the anterior talofibular ligament

    Time frame: 2 years post-treatment

    Signal to noise value of the anterior talofibular ligament

Study contacts

Contact information is provided by the study sponsor or research team.

Anhong Wang, MD

CONTACT

[email protected]

18501325799

Dong Jiang, MD

CONTACT

[email protected]

13811280948

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jan 19, 2022
Registry last updated
Apr 11, 2025

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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