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

NCT ID: NCT06897293

Last Updated: 2025-04-11

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

86 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2026-06-01

Brief Summary

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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.

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 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.

Conditions

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Ankle Sprain Hypermobility, Joint

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 procedure + Suture tape augmentation operation

Modified Broström procedure + Suture tape augmentation operation

Intervention Type PROCEDURE

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

Open Modified Broström group

Patients who accept a modified Broström procedure operation

Modified Broström procedure operation

Intervention Type PROCEDURE

Patients with CLAI and GJL will accept the Modified Broström procedure operation

Interventions

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Modified Broström procedure + Suture tape augmentation operation

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

Intervention Type PROCEDURE

Modified Broström procedure operation

Patients with CLAI and GJL will accept the Modified Broström procedure operation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jiang Dong

Chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dong Jiang, MD

Role: CONTACT

13811280948

Haoxuan Liu, MD

Role: CONTACT

13716163357

Facility Contacts

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Dong Jiang, MD

Role: primary

13811280948

References

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Wittig U, Hohenberger G, Ornig M, Schuh R, Reinbacher P, Leithner A, Holweg P. Improved Outcome and Earlier Return to Activity After Suture Tape Augmentation Versus Brostrom Repair for Chronic Lateral Ankle Instability? A Systematic Review. Arthroscopy. 2022 Feb;38(2):597-608. doi: 10.1016/j.arthro.2021.06.028. Epub 2021 Jul 9.

Reference Type BACKGROUND
PMID: 34252562 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27496909 (View on PubMed)

Other Identifiers

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M2024292

Identifier Type: -

Identifier Source: org_study_id

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