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

Comparison of Modified Broström Repair + Suture Tape and Modified Broström Repair for Chronic Lateral Ankle Instability : A Prospective Cohort Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06897293
Enrollment
86
Registered
2025-03-26
Start date
2021-06-01
Completion date
2026-06-01
Last updated
2026-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Sprain, Hypermobility, Joint

Brief summary

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

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.

Interventions

PROCEDUREModified Broström procedure + Suture tape augmentation operation

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

PROCEDUREModified Broström procedure operation

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

Sponsors

Peking University Third Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The American Orthopaedic Foot and Ankle Society (AOFAS) scorepostoperative AOFAS score at 1 yearThis score is a primary scale for lateral ankle instability, ranges from 0-100, and the higher of the score is associate with a better outcome.

Secondary

MeasureTime frameDescription
Anterior displacement and talar tilt angle in stress radiographypostoperative radiographic measures at 2 yearsThe outcomes are common indicators for evaluation the lateral stability of ankle, and can be evaluated through same stress radiography
Rate of re-injurythe rate of re-injury at 2 yearsThe rate of patients re-sprain after the surgery

Countries

China

Contacts

CONTACTDong Jiang, MD
bysyjiangdong@126.com13811280948
CONTACTHaoxuan Liu, MD
2210301304@stu.pku.edu.cn13716163357

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 21, 2026