Relevance of Osteochondral Lesions in Ankle Microinstability
The goal of this clinical trial is to learn if treating only the anterior talofibular ligament (ATFL) tear with ligament repair is as effective as treating both the ligament tear and the associated osteochondral lesion of the talus at the same time in adults with ankle instability and pain.
The main questions it aims to answer are:
- Do patients who undergo both ligament repair and treatment of the cartilage lesion have better clinical and functional outcomes than those who only have the ligament repaired?
- Is there a difference in pain relief, recovery time, and return to physical activity between the two approaches?
Researchers will compare patients who receive isolated ligament repair to those who receive ligament repair plus microfracture surgery to see if treating both injuries provides better results.
Participants will:
- Be randomly assigned to one of the two treatment groups.
- Undergo surgery by the same surgeon.
- Complete questionnaires about ankle function and pain before surgery and at multiple follow-up points.
- Have physical exams and imaging to assess ankle stability and healing.
Study Overview
Status
Conditions
Detailed Description
This randomized controlled trial investigates the clinical relevance of concomitant osteochondral lesions of the talus in patients undergoing surgical treatment for chronic ankle instability (CAI). Despite successful ligament reconstruction, a substantial proportion of patients report persistent pain, possibly due to associated intra-articular pathology. The study aims to determine whether addressing the osteochondral lesion during the same surgical procedure provides additional clinical or functional benefit compared to isolated ligament repair.
Sixty adult patients with symptomatic CAI and a concomitant talar osteochondral lesion (≤150 mm², Berndt-Harty stage I-IIb) were randomly assigned to two parallel groups. Both groups underwent arthroscopic all-inside anterior talofibular ligament (ATFL) repair. In the experimental group, additional curettage and microfracture of the osteochondral lesion were performed. A standardized rehabilitation protocol was followed, with return to sport permitted at three months for the isolated repair group, and four months for the combined intervention group due to the more extensive surgical gesture.
Primary and secondary outcomes were assessed using validated scales (AOFAS, Karlsson, SEFAS, and VAS) at baseline, and at 1, 3, 6, 12, and 24 months postoperatively. The minimum follow-up period was two years. Statistical analysis included mixed ANOVA for repeated measures and adjustment for multiple comparisons. The study was powered to detect clinically significant differences in AOFAS scores between groups, with a sample size of 30 per group allowing for 20% attrition.
This study addresses a current gap in the literature regarding the management of osteochondral lesions in CAI and provides level I evidence to guide treatment decisions in patients with combined ligamentous and chondral pathology.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Terrassa, Spain, 08227
- Consorci Sanitari de Terrassa
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with an anterior talofibular ligament (ATFL) tear
- Presence of an osteochondral lesion (OCL) <150 mm²
- OCL classified as stage I-IIb according to the Berndt & Harty classification
- Clinical signs of ankle instability
- Pain in the tibiotalar joint
- Incomplete symptom resolution after prior non-surgical treatment
- Age over 18 years
Exclusion Criteria:
- Congenital or post-traumatic bone deformity of the ankle or foot on the affected side
- Previous surgery on the affected limb
- Neuromuscular disorders
- Generalized joint hyperlaxity (Beighton Score)
- Medial ankle instability (due to deltoid ligament injury)
- Presence of OCL >150 mm²
- Presence of multiple OCLs or other concomitant intra- or extra-articular lesions
- History of ankle fracture
- Lack of signed informed consent
- Body mass index >30 Age under 18 years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: REC (Reconstruction Only) Group
This group underwent only the anterior talofibular ligament (ATFL) repair using the all-inside arthroscopic technique.
|
This intervention involves an isolated all-inside arthroscopic repair of the anterior talofibular ligament (ATFL) without addressing the coexisting osteochondral lesion of the talus.
It is intended for patients with chronic ankle instability and a concomitant talar osteochondral lesion, where only the ligamentous injury is treated.
Patients follow a standard rehabilitation protocol with return to sports allowed after 3 months.
|
|
Experimental: REC+MIC (Reconstruction with Microfracture) Group
This group underwent both the ATFL repair and the additional procedure of curettage and microfracture for the osteochondral lesion of the talus via arthroscopy.
|
This intervention involves an isolated all-inside arthroscopic repair of the anterior talofibular ligament (ATFL) without addressing the coexisting osteochondral lesion of the talus.
It is intended for patients with chronic ankle instability and a concomitant talar osteochondral lesion, where only the ligamentous injury is treated.
Patients follow a standard rehabilitation protocol with return to sports allowed after 3 months.
This intervention consists of an arthroscopic debridement and microfracture of a symptomatic osteochondral lesion of the talus.
Postoperative rehabilitation is extended due to the cartilage procedure, delaying return to sports until 4 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in AOFAS (American Orthopaedic Foot and Ankle Society) score
Time Frame: Baseline, 3 months, 6 months, 12 months, and 24 months postoperative
|
Evaluation of functional outcome using the AOFAS Ankle-Hindfoot Scale, which combines pain, function, and alignment.
The AOFAS score ranges from 0 (severe disability) to 100 (normal function).
|
Baseline, 3 months, 6 months, 12 months, and 24 months postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Surgical failure and reintervention rate
Time Frame: Any time during the 24-month follow-up period
|
Number of participants requiring additional surgical procedures on the same ankle due to persistent symptoms or complications related to the initial intervention.
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Any time during the 24-month follow-up period
|
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Change in Karlsson score
Time Frame: Baseline, 3 months, 6 months, 12 months, and 24 months postoperative
|
Assessment of ankle instability and function using the Karlsson scoring scale.
The Karlsson score ranges from 0 (severe instability and dysfunction) to 100 (normal ankle function).
|
Baseline, 3 months, 6 months, 12 months, and 24 months postoperative
|
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Change in SEFAS (Self-reported Foot and Ankle Score)
Time Frame: Baseline, 3 months, 6 months, 12 months, and 24 months postoperative
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Patient-reported questionnaire evaluating pain and function in the foot and ankle.
The SEFAS score ranges from 0 (severe disability) to 48 (normal function).
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Baseline, 3 months, 6 months, 12 months, and 24 months postoperative
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Change in Visual Analogue Scale (VAS) for pain
Time Frame: Baseline, 1 month, 3 months, 6 months, 12 months, and 24 months postoperative
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Patient-reported level of pain using a 10-point visual scale.
The Visual Analogue Scale (VAS) for pain ranges from 0 (no pain) to 10 (worst imaginable pain).
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Baseline, 1 month, 3 months, 6 months, 12 months, and 24 months postoperative
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: RAÚL FIGA BARRIOS, Consultant in the Foot and Ankle Unit of the Department of Orthopedic Surgery and Traumatology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 01-20-105-055
- MED-2022-05 (Other Identifier: Universitat Internacional de Catalunya)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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