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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

114 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-01

Study Completion Date

2025-06-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ankle Sprains Hypermobility Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Open Modified Broström +Suture tape augmentation group

Patients who accept a modified Broström +Suture tape augmentation operation

Modified Broström + Suture tape augmentation operation

Intervention Type PROCEDURE

Patients with CLAI and GJL will accept the Modified Broström + Suture tape augmentation operation

Anatomic reconstruction operation group

Patients who accept an anatomic reconstruction

Anatomic reconstruction operation

Intervention Type PROCEDURE

Anatomic reconstruction operation

Open Modified Broström group

Patients who under went open Modified Broström-Gould surgery

Open Modified Broström procedure

Intervention Type PROCEDURE

Open Modified Broström-Gould surgery

Interventions

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Modified Broström + Suture tape augmentation operation

Patients with CLAI and GJL will accept the Modified Broström + Suture tape augmentation operation

Intervention Type PROCEDURE

Anatomic reconstruction operation

Intervention Type PROCEDURE

Open Modified Broström procedure

Open Modified Broström-Gould surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No