Lateral Ligament, AnkleNCT06947317
Relevance of Osteochondral Lesions in Ankle Microinstability
A study testing Arthroscopic anterior talofibular ligament repair and Talar chondral lesion treatment using microfracture technique in people with Lateral Ligament, Ankle and Cartilage, Articular, run by RAUL FIGA BARRIOS at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lateral Ligament, Ankle, Cartilage, Articular
- What is being tested?
- Arthroscopic anterior talofibular ligament repair and Talar chondral lesion treatment using microfracture technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteSpain
- Study dates
- 5 Aug 2020to 16 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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.
Read the 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.
- Conditions
- Lateral Ligament, Ankle, Cartilage, Articular
- Being tested
- Arthroscopic anterior talofibular ligament repair, Talar chondral lesion treatment using microfracture technique
- Keywords
- Cartilage, Articular, Lateral Ligament, Ankle, Arthroscopy, Ankle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic anterior talofibular ligament repairProcedure or surgery
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.
Talar chondral lesion treatment using microfracture techniqueProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| REC (Reconstruction Only) Group | Active comparator | This group underwent only the anterior talofibular ligament (ATFL) repair using the all-inside arthroscopic technique. Receives: Procedure: Arthroscopic anterior talofibular ligament repair |
| 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. Receives: Procedure: Arthroscopic anterior talofibular ligament repair; Procedure: Talar chondral lesion treatment using microfracture technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 3 months, 6 months, 12 months, and 24 months postoperative
Secondary outcomes (4)
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).
Measured: Baseline, 3 months, 6 months, 12 months, and 24 months postoperative
Change in SEFAS (Self-reported Foot and Ankle Score)
Patient-reported questionnaire evaluating pain and function in the foot and ankle. The SEFAS score ranges from 0 (severe disability) to 48 (normal function).
Measured: 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).
Measured: 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.
Measured: Any time during the 24-month follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start5 Aug 2020
- Primary completion16 Dec 2024
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lateral Ligament, AnkleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAUL FIGA BARRIOS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, RAUL FIGA BARRIOS, Consorci Sanitari de Terrassa
- Investigators
- RAÚL FIGA BARRIOS, Principal investigator, Consultant in the Foot and Ankle Unit of the Department of Orthopedic Surgery and Traumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947317
- Sponsor's protocol ID
- 01-20-105-055
- Other IDs
- MED-2022-05
- Status last verified
- Apr 2025
- First submitted
- 21 Apr 2025
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 41065921
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relevance of Osteochondral Lesions in Ankle Microinstability
- ClinicalTrials.gov ID
- NCT06947317
- Acronym / sponsor ID
- 01-20-105-055
- Conditions
- Lateral Ligament, Ankle, Cartilage, Articular
- Keywords
- Cartilage, Articular, Lateral Ligament, Ankle, Arthroscopy, Ankle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- RAUL FIGA BARRIOSUniversity, hospital or other
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REC (Reconstruction Only) Group | Active comparator | Procedure: Arthroscopic anterior talofibular ligament repairThis group underwent only the anterior talofibular ligament (ATFL) repair using the all-inside arthroscopic technique. |
| REC+MIC (Reconstruction with Microfracture) Group | Experimental | Procedure: Arthroscopic anterior talofibular ligament repair, Procedure: Talar chondral lesion treatment using microfracture techniqueThis group underwent both the ATFL repair and the additional procedure of curettage and microfracture for the osteochondral lesion of the talus via arthroscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthroscopic anterior talofibular ligament repairThis 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. | Procedure or surgery | REC (Reconstruction Only) Group, REC+MIC (Reconstruction with Microfracture) Group |
| Talar chondral lesion treatment using microfracture techniqueThis 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. | Procedure or surgery | REC+MIC (Reconstruction with Microfracture) Group |
Primary outcome
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).
4 secondary outcomes
Change in Karlsson score
Time frame: Baseline, 3 months, 6 months, 12 months, and 24 months postoperative
Change in SEFAS (Self-reported Foot and Ankle Score)
Time frame: Baseline, 3 months, 6 months, 12 months, and 24 months postoperative
Change in Visual Analogue Scale (VAS) for pain
Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, and 24 months postoperative
Surgical failure and reintervention rate
Time frame: Any time during the 24-month follow-up period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Derived from this study: PubMed 41065921Figa 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
RAÚL FIGA BARRIOS principal investigator
Consultant in the Foot and Ankle Unit of the Department of Orthopedic Surgery and Traumatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic anterior talofibular ligament repair and Talar chondral lesion treatment using microfracture technique in people with Lateral Ligament, Ankle and Cartilage, Articular, run by RAUL FIGA BARRIOS at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in AOFAS (American Orthopaedic Foot and Ankle Society) score (time frame: Baseline, 3 months, 6 months, 12 months, and 24 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06947317, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.