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NCT Number: NCT05698446

Comparison of MBR + Suture Tape, MBR, and Anatomic Reconstruction for CLAI in GJL Cases: A Prospective Cohort Study

GJL is a risk factor for postoperative recurrent instability following an MBR for CLAI. BPR with suture tape augmentation and anatomic reconstruction may provide more strength and stability. However, BPR with suture tape augmentation may lead to rejection of the suture tape, while anatomic reconstruction may be associated with more trauma. In addition, the outcomes between the BPR with suture tape augmentation and anatomic reconstruction were unknown.

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Key information

Conditions

Ankle Sprains Ankle Injuries Hypermobility Syndrome Leg Injuries 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

Generalized joint laxity (GJL) is a risk factor for postoperative recurrent instability following an open modified Broström repair (MBR) for chronic lateral ankle instability (CLAI). MBR with suture tape augmentation and anatomic reconstruction may provide more strength and stability. However, BPR with suture tape augmentation may lead to rejection of the suture tape, while anatomic reconstruction may be associated with more trauma. In addition, the outcomes between the BPR with suture tape augmentation and anatomic reconstruction were unknown.

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 + Suture tape augmentation operation

Procedure

Patients with CLAI and GJL will accept the Modified Broström + Suture tape augmentation operation

Anatomic reconstruction operation

Procedure

Anatomic reconstruction operation

Open Modified Broström procedure

Procedure

Open Modified Broström-Gould surgery

Primary outcomes

  1. Karlsson-Peterson score

    Time frame: postoperative Karlsson score at 1 year

    This score is a primary scale for lateral ankle instability, with a maximum value of 100 and minimum value of 0. Larger Karlsson-Peterson score represents better ankle functional outcomes.

  2. Karlsson-Peterson score

    Time frame: postoperative Karlsson score at 2 years

    This score is a primary scale for lateral ankle instability, with a maximum value of 100 and minimum value of 0. Larger Karlsson-Peterson score represents better ankle functional outcomes.

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

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

Comparison of Modified Broström Repair + Suture Tape and Anatomic Reconstruction for CLAI in Chronic Lateral Ankle Instability in Generalized Joint Laxity Cases: A Prospective Cohort Study

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jan 26, 2023
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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