Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06897293

Comparison of MBR + Suture Tape and MBR for CLAI : A Prospective Cohort Study

GJL is a risk factor for postoperative recurrent instability following an MBR for CLAI. Additional suture tape augmentation has been suggested to provide more strength and stability. However, the outcomes of the MBP with suture tape augmentation were unknown, which requires further exploration.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

15 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University Third Hospital

Beijing, Beijing Municipality, 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 may provide more strength and stability. However, BPR with suture tape augmentation may lead to rejection of the suture tape. In addition, the outcomes of the MBP with suture tape augmentation 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 instability
  • Beighton score ≥4
  • Age with 18 to 60 years

Exclusion criteria

  • Patients with an acute or subacute ankle injury
  • 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 procedure + Suture tape augmentation operation

Procedure

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

Modified Broström procedure operation

Procedure

Patients with CLAI and GJL will accept the Modified Broström procedure operation

Primary outcomes

  1. The American Orthopaedic Foot and Ankle Society (AOFAS) score

    Time frame: postoperative AOFAS score at 1 year

    This score is a primary scale for lateral ankle instability, ranges from 0-100, and the higher of the score is associate with a better outcome.

  2. The American Orthopaedic Foot and Ankle Society (AOFAS) score

    Time frame: postoperative AOFAS score at 2 years

    This score is a primary scale for lateral ankle instability, ranges from 0-100, and the higher of the score is associate with a better outcome.

  3. The American Orthopaedic Foot and Ankle Society (AOFAS) score

    Time frame: postoperative AOFAS score at 6 months

    This score is a primary scale for lateral ankle instability, ranges from 0-100, and the higher of the score is associate with a better outcome.

  4. The American Orthopaedic Foot and Ankle Society (AOFAS) score

    Time frame: postoperative AOFAS score at 3 months

    This score is a primary scale for lateral ankle instability, ranges from 0-100, and the higher of the score is associate with a better outcome.

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, and can be evaluated through same stress radiography

  2. Rate of re-injury

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

    The rate of patients re-sprain after the surgery

Other outcomes

  1. Signal to noise value of anterior talofibular ligament

    Time frame: 6 months post-treatment

    Signal to noise value of the anterior talofibular ligament

  2. Signal to noise value of the anterior talofibular ligament

    Time frame: 12 months post-treatment

    Signal to noise value of the anterior talofibular ligament

  3. Signal to noise value of the anterior talofubular ligament

    Time frame: 24 months post-treatment

    Signal to noise value of the anterior talofibular ligament

Study contacts

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

Dong Jiang, MD

CONTACT

[email protected]

13811280948

Haoxuan Liu, MD

CONTACT

[email protected]

13716163357

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

Comparison of Modified Broström Repair + Suture Tape and Modified Broström Repair for Chronic Lateral Ankle Instability : A Prospective Cohort Study

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Mar 26, 2025
Registry last updated
May 20, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.