Ankle osteochondral lesion repair with a bone marrow–enriched scaffold and retrograde drilling

Evaluation of the Osteointegrative and Regenerative Capacity of a Scaffold Enriched With Bone Marrow-Derived Cells at the Subchondral Level, Associated With Retrograde Drilling

This approach will try a bone marrow–enriched scaffold combined with retrograde drilling to repair ankle osteochondral lesions in adults aged 18–55 with subchondral cysts or intact cartilage.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Istituto Ortopedico Rizzoli (Academic / other)
• Locations: 1 site (Bologna)
• Trial ID: NCT07555899 on ClinicalTrials.gov

What this trial studies

The procedure fills subchondral talar defects with a scaffold seeded with autologous bone marrow‑derived cells and creates channels via retrograde drilling to stimulate bone and cartilage repair. The retrograde, extra‑articular technique is intended to reach cystic lesions while preserving an intact cartilage surface. Patients undergo bone marrow aspiration, scaffold preparation and placement at the Rizzoli Orthopaedic Institute, followed by clinical follow‑up. Functional and quality‑of‑life scores such as AOFAS and SF‑36 will be used to monitor outcomes.

Who should consider this trial

Good fit: Adults aged 18–55 with chronic talar subchondral cysts or large osteochondral lesions with intact or stable cartilage and impaired daily function who can give informed consent are ideal candidates.

Not a fit: Patients with damaged or unstable articular cartilage, active infection, age outside 18–55, or other exclusion criteria are unlikely to benefit from this specific procedure.

Why it matters

Potential benefit: If successful, this technique could reduce pain and improve ankle function by promoting subchondral bone regeneration while avoiding damage to intact cartilage.

How similar studies have performed: Retrograde drilling is an established option for subchondral cysts and small studies of bone marrow‑enriched scaffolds have shown promising but not definitive results, so the combined approach is plausible but not yet proven.

Eligibility criteria

All patients diagnosed with subchondral cysts with intact cartilage or massive osteochondral lesions (OCLs) of the ankle joint treated with retrograde drilling and application of bone marrow aspirate on a scaffold at the First Clinic of the Rizzoli Orthopaedic Institute in Bologna will be included, in accordance with the criteria specified below.

INCLUSION CRITERIA:

Patients with one or more chronic cystic subchondral lesions of the talus (Grade IIA according to the Giannini classification); Patients with one or more chronic subchondral lesions with intact cartilage or large chronic OCLs (Grade IIA according to the Giannini classification); Age ≥ 18 years and ≤ 55 years; Ankle pain with limitation in normal activities of daily living (American Orthopaedic Foot and Ankle Score - AOFAS \< 85, Short Form-36 - SF-36 \< 86); Patients able to provide written informed consent to participate in the study.

EXCLUSION CRITERIA:

Patients \< 18 years or \> 55 years of age; Presence of active infections at the time of study inclusion; Positive status for HIV, HBV, or HCV; Pregnancy; Patients with autoimmune or rheumatologic diseases; Disorders of the immune system; Presence of severe malalignment of the tibiotalar joint in the coronal plane, whether supra-, intra-, or infra-articular (distal tibial articular angle \< or \> 10°, talar tilt \> 8°, severe cavus or flatfoot); Any other condition or disease that contraindicates surgical treatment.

Where this trial is running

Bologna

• Istituto Ortopedico Rizzoli — Bologna, Italy (Recruiting)

Study contacts

• Study coordinator: Antotnio Mazzotti, MD PhD

Conditions Osteochondral Lesion