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

Comparison of Modified Broström Repair + Suture Tape and Anatomic Reconstruction for CLAI in Chronic Lateral Ankle Instability in Generalized Joint Laxity Cases: A Prospective Cohort Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05698446
Enrollment
114
Registered
2023-01-26
Start date
2021-11-01
Completion date
2025-06-01
Last updated
2025-04-11

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

Conditions

Ankle Sprains, Hypermobility Syndrome

Brief summary

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.

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 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.

Interventions

PROCEDUREModified Broström + Suture tape augmentation operation

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

PROCEDUREAnatomic reconstruction operation

Anatomic reconstruction operation

PROCEDUREOpen Modified Broström procedure

Open Modified Broström-Gould surgery

Sponsors

Peking University Third Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Karlsson-Peterson scorepostoperative Karlsson score at 1 yearThis score is a primary scale for lateral ankle instability, with a maximum value of 100 and minimum value of 0. Larger Karlsson-Peterson score represents better ankle functional outcomes.

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

Other

MeasureTime frameDescription
Rate of re-injurythe rate of re-injury at 2 yearsAfter surgery, the rate of patients re-sprain

Countries

China

Contacts

Primary ContactDong Jiang, MD
bysyjiangdong@126.com13811280948
Backup ContactAnhong Wang, MD
1811210533@pku.edu.cn18501325799

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026