Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MED-2022-05 | Other Identifier | Universitat Internacional de Catalunya |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REC (Reconstruction Only) Group | Active Comparator | This group underwent only the anterior talofibular ligament (ATFL) repair using the all-inside arthroscopic technique. |
|
| REC+MIC (Reconstruction with Microfracture) Group | Experimental | This group underwent both the ATFL repair and the additional procedure of curettage and microfracture for the osteochondral lesion of the talus via arthroscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arthroscopic anterior talofibular ligament repair | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in AOFAS (American Orthopaedic Foot and Ankle Society) score | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Karlsson score | 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 |
| Change in SEFAS (Self-reported Foot and Ankle Score) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| RAÚL FIGA BARRIOS | Consultant in the Foot and Ankle Unit of the Department of Orthopedic Surgery and Traumatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Consorci Sanitari de Terrassa | Terrassa | Spain | 08227 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41065921 | Derived | Figa Barrios R, Mora-Guix JM, Roza Miguel PO, Vila-Rico J. Additional cartilage treatment for small defects in chronic ankle instability shows no mid-term benefit and delays recovery: a randomized controlled trial. J Orthop Traumatol. 2025 Oct 9;26(1):67. doi: 10.1186/s10195-025-00880-9. |
Not provided
Not provided
De-identified individual participant data (IPD) that underlie the results reported in this article will be made available upon reasonable request to the corresponding author, for purposes of academic and non-commercial research. Requesters will need to provide a methodologically sound proposal and agree to a data access agreement to ensure confidentiality and appropriate use.
Data will be available beginning 6 months after publication of the primary results and will remain available for a period of 5 years.
De-identified individual participant data (IPD) that underlie the results reported in this article will be made available upon reasonable request to the corresponding author, for purposes of academic and non-commercial research. Requesters will need to provide a methodologically sound proposal and agree to a data access agreement to ensure confidentiality and appropriate use.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Talar chondral lesion treatment using microfracture technique | Procedure | 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. |
|
Patient-reported questionnaire evaluating pain and function in the foot and ankle. The SEFAS score ranges from 0 (severe disability) to 48 (normal function). |
| Baseline, 3 months, 6 months, 12 months, and 24 months postoperative |
| Change in Visual Analogue Scale (VAS) for pain | 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). | Baseline, 1 month, 3 months, 6 months, 12 months, and 24 months postoperative |
| Surgical failure and reintervention rate | Number of participants requiring additional surgical procedures on the same ankle due to persistent symptoms or complications related to the initial intervention. | Any time during the 24-month follow-up period |