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The Clinical Outcomes of the Modified Broström vs Anatomic Reconstruction Operation in CLAI and GJL

The Clinical Outcomes Comparing the Modified Broström vs Anatomic Reconstruction Operation in Chronic Lateral Ankle Instability and Generalized Joint Laxity

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05196906
Enrollment
100
Registered
2022-01-19
Start date
2020-01-01
Completion date
2025-12-31
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, Instability, Joint, Joint Hypermobility

Keywords

chronic lateral ankle instability, generalized joint laxity, re-injury, modified Brostrom operation, anatomic reconstruction

Brief summary

Investigators designed this prospective cohort study to compare the clinical outcomes of modified Broström operation and anatomical reconstruction for the treatment of CLAI and GJL.

Detailed description

The modified Broström operation is still the first line to treat chronic lateral ligament instability (CLAI). However, some studies indicate the modified Broström operation may bring a higher rate of re-injury in generalized joint laxity (GJL). Anatomical reconstruction was reported to generate similar results and less rate of re-injury compared in patients with CLAI. However, the clinical outcomes of the two operations are not discussed in CLAI and GJL. So, investigators designed this prospective cohort study. The primary outcomes are Karlsson, Foot and Ankle Outcome Score (FAOS), and Foot and Ankle Ability Measure (FAAM) scores. The secondary outcomes are anterior displacement and talar tilt angle in stress radiography, the rate of re-injury.

Interventions

PROCEDUREModified Broström operation and anatomic reconstruction operation

Patients with CLAI and GJL will accept the Modified Broström operation or anatomic reconstruction operation.

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 scorepostoperative Karlsson score at 1 year.This score is a primary scale for lateral ankle instability

Secondary

MeasureTime frameDescription
Anterior displacement and talar tilt angle in stress radiographypostoperative radiographic measures at 2 years.The outcomes are common indicators for evaluation the lateral stability of ankle

Other

MeasureTime frameDescription
Rate of re-injurythe rate of re-injury at 2 years.After surgery, the rate of patients re-sprain
Signal to noise value of the anterior talofibular ligament6 months post-treatmentSignal to noise value of the anterior talofibular ligament

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