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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Ankle Sprains; Hypermobility Syndrome
• Intervention / Treatment: Procedure: Modified Broström + Suture tape augmentation operation; Procedure: Anatomic reconstruction operation; Procedure: Open Modified Broström procedure

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 114

Contacts and Locations

• Study Contact: Name: Dong Jiang, MD; Phone Number: 13811280948; Email: bysyjiangdong@126.com
• Study Contact Backup: Name: Anhong Wang, MD; Phone Number: 18501325799; Email: 1811210533@pku.edu.cn

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University Third Hospital
    • Contact: Dong Jiang, MD; Phone Number: 13811280948; Email: bysyjiangdong@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Anatomic reconstruction operation group; Patients who accept an anatomic reconstruction	Procedure: Anatomic reconstruction operation; Anatomic reconstruction operation
Open Modified Broström +Suture tape augmentation group; Patients who accept a modified Broström +Suture tape augmentation operation	Procedure: Modified Broström + Suture tape augmentation operation; Patients with CLAI and GJL will accept the Modified Broström + Suture tape augmentation operation
Open Modified Broström group; Patients who under went open Modified Broström-Gould surgery	Procedure: Open Modified Broström procedure; Open Modified Broström-Gould surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anterior displacement and talar tilt angle in stress radiography	The outcomes are common indicators for evaluation the lateral stability of ankle	postoperative radiographic measures at 2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of re-injury	After surgery, the rate of patients re-sprain	the rate of re-injury at 2 years

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: January 16, 2023
• First Submitted That Met QC Criteria: January 24, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Ankle Injuries
• Other Study ID Numbers: M2022514

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The demographics data, Beighton score, primary and secondary outcomes would be available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No