Active — Not RecruitingNot Applicable

Analysis of Prognosis and Risk Factors of LAL Reconstruction Procedure for Patients With AF of the LAL: a Prospective Cohort Study

China120 participantsStarted 2024-01-27

Plain-language summary

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.

Who can participate

Age range18 Years – 60 Years

SexALL

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Inclusion criteria

✓. Age 18-60 years old
✓. 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.
✓. Patients with poor results after more than 3 months of conservative treatment with rest/topical/oral non-steroidal anti-inflammatory drugs
✓. Patients voluntarily participate in clinical trials, sign informed consent, and can cooperate with clinical follow-up

Exclusion criteria

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

What they're measuring

Karlsson score

Timeframe: 2 weeks, 3 months, 6 months, 1 year, and 2 years

Trial details

NCT IDNCT06277544

SponsorPeking University Third Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-06-30

View on ClinicalTrials.gov More Avulsion Fracture of Lateral Ankle Ligament trials