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

P

Peking University

Status

Enrolling

Conditions

Ankle Sprains
Hypermobility Syndrome

Treatments

Procedure: Anatomic reconstruction operation
Procedure: Open Modified Broström procedure
Procedure: Modified Broström + Suture tape augmentation operation

Study type

Observational

Funder types

Other

Identifiers

NCT05698446
M2022514

Details and patient eligibility

About

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.

Full 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.

Enrollment

114 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

114 participants in 3 patient groups

Open Modified Broström +Suture tape augmentation group
Description:
Patients who accept a modified Broström +Suture tape augmentation operation
Treatment:
Procedure: Modified Broström + Suture tape augmentation operation
Anatomic reconstruction operation group
Description:
Patients who accept an anatomic reconstruction
Treatment:
Procedure: Anatomic reconstruction operation
Open Modified Broström group
Description:
Patients who under went open Modified Broström-Gould surgery
Treatment:
Procedure: Open Modified Broström procedure

Trial contacts and locations

1

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Central trial contact

Anhong Wang, MD; Dong Jiang, MD

Data sourced from clinicaltrials.gov

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