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

Analysis of Prognosis and Risk Factors of Lateral Ankle Ligament Reconstruction Procedure for Patients With Avulsion Fracture of the Lateral Ankle Ligament: a Prospective Cohort Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Avulsion Fracture of Lateral Ankle Ligament
• Intervention / Treatment: Procedure: lateral ankle ligament repair or reconstruction

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 Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with chronic lateral ankle instability with or without lateral ankle avulsion fracture meeting surgical indications.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
rupture group; rupture of lateral ankle ligament	Procedure: lateral ankle ligament repair or reconstruction; repair or reconstruction procedure for lateral ankle ligament
fracture group; avulsion fracture of lateral ankle ligament	Procedure: lateral ankle ligament repair or reconstruction; repair or reconstruction procedure for lateral ankle ligament

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Karlsson score	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	2 weeks, 3 months, 6 months, 1 year, and 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS)	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.	2 weeks, 3 months, 6 months, 1 year, and 2 years
American Orthopaedic Foot and Ankle Society (AOFAS)	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.	2 weeks, 3 months, 6 months, 1 year, and 2 years
Tegner Scale	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.	2 weeks, 3 months, 6 months, 1 year, and 2 years

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Director: Guo Qinwei, MD, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: February 19, 2024
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Actual): February 26, 2024

Study Record Updates

• Last Update Posted (Actual): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Fractures, Avulsion
• Other Study ID Numbers: M2024087

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No