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

P

Peking University

Status

Enrolling

Conditions

Ankle Sprain
Hypermobility, Joint

Treatments

Procedure: Modified Broström procedure operation
Procedure: Modified Broström procedure + Suture tape augmentation operation

Study type

Observational

Funder types

Other

Identifiers

NCT06897293
M2024292

Details and patient eligibility

About

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.

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 may provide more strength and stability. However, BPR with suture tape augmentation may lead to rejection of the suture tape. In addition, the outcomes of the MBP with suture tape augmentation were unknown.

Enrollment

86 estimated patients

Sex

All

Ages

15 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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

Trial design

86 participants in 2 patient groups

Open Modified Broström +Suture tape augmentation group
Description:
Patients who accept a modified Broström procedure + Suture tape augmentation operation
Treatment:
Procedure: Modified Broström procedure + Suture tape augmentation operation
Open Modified Broström group
Description:
Patients who accept a modified Broström procedure operation
Treatment:
Procedure: Modified Broström procedure operation

Trial contacts and locations

1

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Central trial contact

Haoxuan Liu, MD; Dong Jiang, MD

Data sourced from clinicaltrials.gov

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