Analysis of Prognosis and Risk Factors of LAL Reconstruction Procedure for Patients With AF of the LAL: 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

ACTIVE_NOT_RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-27

Study Completion Date

2026-06-30

Brief Summary

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To compare the clinical outcomes of CAI patients with and without lateral ankle avulsion fracture after ligament repair/reconstruction, and to analyze the risk factors associated with the outcome.

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Detailed Description

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80 patients with external ankle ligament injury without avulsion fracture and 40 patients with external ankle ligament injury combined with avulsion fracture were treated by surgery in our department. The outcomes included Karlsson score, VAS, AOFAS and Tegner score. The outcomes were compared between the two groups, and the risk factors were analyzed.

Conditions

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Avulsion Fracture of Lateral Ankle Ligament

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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rupture group

rupture of lateral ankle ligament

lateral ankle ligament repair or reconstruction

Intervention Type PROCEDURE

repair or reconstruction procedure for lateral ankle ligament

fracture group

avulsion fracture of lateral ankle ligament

lateral ankle ligament repair or reconstruction

Intervention Type PROCEDURE

repair or reconstruction procedure for lateral ankle ligament

Interventions

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lateral ankle ligament repair or reconstruction

repair or reconstruction procedure for lateral ankle ligament

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Age 18-60 years old
2. Chronic pain or instability in the ankle, injury to the lateral collateral ligament of the ankle determined by MRI examination of the ankle, and distal avulsion fracture of the fibula indicated by CT examination.
3. Patients with poor results after more than 3 months of conservative treatment with rest/topical/oral non-steroidal anti-inflammatory drugs
4. Patients voluntarily participate in clinical trials, sign informed consent, and can cooperate with clinical follow-up

Exclusion Criteria

1. Persons who have participated in clinical trials of other drugs or medical devices within the last 6 months
2. Malalignment of ankle joint force (varus or valgus \>5 degrees)
3. Chronic specific synovitis (rheumatoid, pigmented villonodular synovitis, etc.)
4. Patients with joint fibrosis, joint stiffness, and obvious limited movemente. Moderate to severe osteoarthritis (Takakura stage III or IV)

f. Patients with contraindications to MRI g. Hemophiliacs h. Patients with systemic conditions that cannot tolerate surgery

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No