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Ankle cartilage repair gets a boost: scaffold and stem cells tested in new trial

NCT ID NCT07555899

Disease control Sponsor: Istituto Ortopedico Rizzoli Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tests a new surgical technique for people with large ankle cartilage and bone defects. Surgeons will drill into the damaged bone and place a scaffold enriched with the patient's own bone marrow cells to help regenerate tissue. The goal is to see if this approach improves pain and function, and whether MRI scans show better healing at 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
scaffold enriched with bone marrow-derived cells
What this could lead to
If successful, this could offer a new surgical option to repair large ankle cartilage and bone defects, potentially reducing pain and improving joint function.
What could go wrong
This is a very small pilot study (20 people) with no control group, so results may not be generalizable. The procedure is complex and carries surgical risks like infection or incomplete healing.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

osteochondritis dissecans

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Osteochondral lesion

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Istituto Ortopedico Rizzoli

    RECRUITING

    Bologna, Italy

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