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

Active, not recruiting

• Conditions: Avulsion Fracture of Lateral Ankle Ligament
• Interventions: Procedure: lateral ankle ligament repair or reconstruction

• Registration Number: NCT06277544
• Lead Sponsor: Peking University Third Hospital

Brief 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.

Detailed Description

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.

Study Timeline

• Status Verified: 2024-01
• Study Start: 2024-01-27
• Study First Submitted: 2024-02-19
• Study First Submitted QC: 2024-02-19
• Last Update Submitted: 2024-02-19
• Study First Posted: 2024-02-26
• Last Update Posted: 2024-02-26
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
rupture group	lateral ankle ligament repair or reconstruction	rupture of lateral ankle ligament
fracture group	lateral ankle ligament repair or reconstruction	avulsion fracture of lateral ankle ligament

Primary Outcome Measures

Name	Time	Method
Karlsson score	2 weeks, 3 months, 6 months, 1 year, and 2 years	The Karlsson score consists of seven questions covering ankle pain, swelling, levels of daily activity and exercise .et al,provided by the patient with objective scores. The minimum and maximum values of Karlsson are 0 and 100, respectively. And higher scores mean a better outcome

Secondary Outcome Measures

Name	Time	Method
Tegner Scale	2 weeks, 3 months, 6 months, 1 year, and 2 years	The Tegner Scale is a tool commonly used to assess the degree of sports injury and the degree of functional recovery, which is graded according to the level of motor activity a participant participates in and the gradual increase in requirements. It is graded on a scale of 0 to 10, with the specific meanings.
Visual Analogue Scale (VAS)	2 weeks, 3 months, 6 months, 1 year, and 2 years	The Visual Analogue Scale (VAS) is designed to present to the respondent a rating scale with minimum constraints. Respondents mark the location on the 10-centimeter line corresponding to the amount of pain they experienced. This gives them the greatest freedom to choose their pain's exact intensity. It also gives the maximum opportunity for each respondent to express a personal response style. The minimum and maximum values of VAS are 10 and 0, respectively. And higher scores mean a worse outcome.
American Orthopaedic Foot and Ankle Society (AOFAS)	2 weeks, 3 months, 6 months, 1 year, and 2 years	The American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score combines subjective scores of pain and function provided by the patient with objective scores based on the surgeon's physical examination of the patient (to assess sagittal motion, hindfoot motion, ankle-hindfoot stability and alignment of the ankle-hindfoot). The scale includes nine items that can be divided into three subscales (pain, function and alignment). The minimum and maximum values of AOFAS are 100 and 0, respectively. And higher scores mean a better outcome.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China