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

NCT05698446 | Recruiting

• 1 other identifier: M2022514
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ankle Sprains; Hypermobility Syndrome

Outcome Measures

Primary Outcomes (2)

• Karlsson-Peterson score

  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.

  postoperative Karlsson score at 1 year

• Karlsson-Peterson score

  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.

  postoperative Karlsson score at 2 years

Secondary Outcomes (1)

• Anterior displacement and talar tilt angle in stress radiography

  postoperative radiographic measures at 2 years

Other Outcomes (1)

• Rate of re-injury

  the rate of re-injury at 2 years

Study Arms (3)

Open Modified Broström +Suture tape augmentation group

Patients who accept a modified Broström +Suture tape augmentation operation

Procedure: Modified Broström + Suture tape augmentation operation

Anatomic reconstruction operation group

Patients who accept an anatomic reconstruction

Procedure: Anatomic reconstruction operation

Open Modified Broström group

Patients who under went open Modified Broström-Gould surgery

Procedure: Open Modified Broström procedure

Interventions

Modified Broström + 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

Anatomic reconstruction operation PROCEDURE

Anatomic reconstruction operation

Anatomic reconstruction operation group

Open Modified Broström procedure PROCEDURE

Open Modified Broström-Gould surgery

Open Modified Broström group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: 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 18- 60 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 pain and instability Beighton score ≥4 Age with 18 to 60 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

RECRUITING

Related Publications (5)

• 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

• Sacks HA, Prabhakar P, Wessel LE, Hettler J, Strickland SM, Potter HG, Fufa DT. Generalized Joint Laxity in Orthopaedic Patients: Clinical Manifestations, Radiographic Correlates, and Management. J Bone Joint Surg Am. 2019 Mar 20;101(6):558-566. doi: 10.2106/JBJS.18.00458. No abstract available.

  PMID: 30893238 BACKGROUND

• Lan R, Piatt ET, Bolia IK, Haratian A, Hasan L, Peterson AB, Howard M, Korber S, Weber AE, Petrigliano FA, Tan EW. Suture Tape Augmentation in Lateral Ankle Ligament Surgery: Current Concepts Review. Foot Ankle Orthop. 2021 Oct 20;6(4):24730114211045978. doi: 10.1177/24730114211045978. eCollection 2021 Oct.

  PMID: 35097476 BACKGROUND

• Michels F, Cordier G, Burssens A, Vereecke E, Guillo S. Endoscopic reconstruction of CFL and the ATFL with a gracilis graft: a cadaveric study. Knee Surg Sports Traumatol Arthrosc. 2016 Apr;24(4):1007-14. doi: 10.1007/s00167-015-3779-1. Epub 2015 Sep 26.

  PMID: 26410096 BACKGROUND

• Cho BK, Park JK, Choi SM, SooHoo NF. A randomized comparison between lateral ligaments augmentation using suture-tape and modified Brostrom repair in young female patients with chronic ankle instability. Foot Ankle Surg. 2019 Apr;25(2):137-142. doi: 10.1016/j.fas.2017.09.008. Epub 2017 Oct 18.

  PMID: 29409289 BACKGROUND

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Central Study Contacts

Dong Jiang, MD

CONTACT

13811280948; bysyjiangdong@126.com

Anhong Wang, MD

CONTACT

18501325799; 1811210533@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: January 16, 2023
• First Posted: January 26, 2023
• Study Start: November 1, 2021
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)