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

Last updated: April 8, 2025
Sponsor: Peking University Third Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sprains

Treatment

Modified Broström + Suture tape augmentation operation

Anatomic reconstruction operation

Open Modified Broström procedure

Clinical Study ID

NCT05698446
M2022514
  • Ages 18-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Patients with an acute or subacute ankle injury (within 3 months) Injury of thedeltoid ligament Alignment of lower extremity greater than 5 degrees Fractures ofthe lower extremity Stage III or IV osteoarthritis Patients who refused toparticipate in the study

Study Design

Total Participants: 114
Treatment Group(s): 3
Primary Treatment: Modified Broström + Suture tape augmentation operation
Phase:
Study Start date:
November 01, 2021
Estimated Completion Date:
June 01, 2025

Study 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.

Connect with a study center

  • Peking University Third Hospital

    Beijing,
    China

    Active - Recruiting

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