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

NCT06897293 | Recruiting

• 1 other identifier: M2024292
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ankle Sprain; Hypermobility, Joint

Outcome Measures

Primary Outcomes (4)

• The American Orthopaedic Foot and Ankle Society (AOFAS) score

  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.

  postoperative AOFAS score at 1 year

• The American Orthopaedic Foot and Ankle Society (AOFAS) score

  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.

  postoperative AOFAS score at 2 years

• The American Orthopaedic Foot and Ankle Society (AOFAS) score

  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.

  postoperative AOFAS score at 6 months

• The American Orthopaedic Foot and Ankle Society (AOFAS) score

  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.

  postoperative AOFAS score at 3 months

Secondary Outcomes (2)

• Anterior displacement and talar tilt angle in stress radiography

  postoperative radiographic measures at 2 years

• Rate of re-injury

  the rate of re-injury at 2 years

Other Outcomes (3)

• Signal to noise value of anterior talofibular ligament

  6 months post-treatment

• Signal to noise value of the anterior talofibular ligament

  12 months post-treatment

• Signal to noise value of the anterior talofubular ligament

  24 months post-treatment

Study Arms (2)

Open Modified Broström +Suture tape augmentation group

Patients who accept a modified Broström procedure + Suture tape augmentation operation

Procedure: Modified Broström procedure + Suture tape augmentation operation

Open Modified Broström group

Patients who accept a modified Broström procedure operation

Procedure: Modified Broström procedure operation

Interventions

Modified Broström procedure + Suture tape augmentation operation PROCEDURE

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

Open Modified Broström +Suture tape augmentation group

Modified Broström procedure operation PROCEDURE

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

Open Modified Broström group

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The patients who go to visit a doctor for persistent lateral ankle pain and instability over three months and invalid conservative treatment, with the age of 15 - 55 years. If the Beighton score of the patient is ≥4 and the exclusion criteria are met, he or she is going to be advised to participate in this study.

You may qualify if:

• Clinical diagnosis of lateral ankle instability
• Beighton score ≥4
• Age with 18 to 60 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, China

RECRUITING

Related Publications (2)

• Wittig U, Hohenberger G, Ornig M, Schuh R, Reinbacher P, Leithner A, Holweg P. Improved Outcome and Earlier Return to Activity After Suture Tape Augmentation Versus Brostrom Repair for Chronic Lateral Ankle Instability? A Systematic Review. Arthroscopy. 2022 Feb;38(2):597-608. doi: 10.1016/j.arthro.2021.06.028. Epub 2021 Jul 9.

  PMID: 34252562 BACKGROUND

• Xu HX, Lee KB. Modified Brostrom Procedure for Chronic Lateral Ankle Instability in Patients With Generalized Joint Laxity. Am J Sports Med. 2016 Dec;44(12):3152-3157. doi: 10.1177/0363546516657816. Epub 2016 Aug 5.

  PMID: 27496909 BACKGROUND

MeSH Terms

Conditions

Ankle Injuries; Joint Instability

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases

Central Study Contacts

Dong Jiang, MD

CONTACT

13811280948; bysyjiangdong@126.com

Haoxuan Liu, MD

CONTACT

13716163357; 2210301304@stu.pku.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 26, 2025
• Study Start: June 1, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)