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AzTrials

Osteochondral LesionNCT07555899

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

A study testing Osteochondral lesions treated with a scaffold enriched with bone marrow-derived cells at the subchondral level combined with retrograde drilling. in people with Osteochondral Lesion, run by Istituto Ortopedico Rizzoli at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Osteochondral lesions of the ankle (OsteoChondral Lesions - OCLs) are defects of the subchondral bone and the overlying articular cartilage that commonly affect young and active patients. The main symptoms include chronic ankle pain, recurrent swelling, stiffness, and instability. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Osteochondral Lesion
What is being tested?
Osteochondral lesions treated with a scaffold enriched with bone marrow-derived cells at the subchondral level combined with retrograde drilling.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteItaly
Study dates
30 Jan 2026to Feb 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Antotnio Mazzotti, MD PhD contact

+39 349 879 8863

antonio.mazzotti@ior.it

Italy1 site, 1 recruiting
  • Istituto Ortopedico Rizzoli

    Bologna

    Cesare Faldini, MD, 0516445064, cesare.faldini@ior.it

    Recruiting

Other trials in Italy

About this study

Osteochondral lesions of the ankle (OsteoChondral Lesions - OCLs) are defects of the subchondral bone and the overlying articular cartilage that commonly affect young and active patients. The main symptoms include chronic ankle pain, recurrent swelling, stiffness, and instability. The ideal treatment for OCLs remains a matter of debate. Various surgical techniques have been proposed, both arthroscopic and open. The choice of treatment depends on several factors, including lesion pathology, patient characteristics, and surgeon preference.

In the presence of subchondral cysts or lesions with intact and stable cartilage surfaces, retrograde drilling is among the most commonly used techniques. This is a reparative, extra-articular procedure that reaches the lesion via a retrograde approach, thereby preventing iatrogenic cartilage damage. The surgical technique involves creating multiple channels in the subchondral bone using a Kirschner wire to stimulate the migration of mesenchymal stem cells, promote revascularization of the lesion site, and induce new bone formation.

Read more

Although retrograde drilling has shown good results over the years, concerns remain regarding the regenerative potential of subchondral bone, particularly in the case of large lesions or cysts. For this reason, various biological adjuncts have been combined with drilling in an attempt to improve treatment efficacy, with inconclusive results. Among the proposed modifications is that of Beck et al., who expanded the talar tunnel to allow for improved debridement, subsequently filling it with bone graft.

Another treatment option is subchondroplasty, which has shown promising results; however, few studies are available for the ankle, and significant complications have been reported. Therefore, the management of large subchondral cysts remains controversial.

In cases of large OCLs with cartilage damage, regenerative treatments are generally preferred, and several surgical techniques can be performed. However, these approaches are also controversial, as they are typically performed via an anterograde approach and involve extensive debridement of the overlying damaged cartilage, sometimes removing healthy cartilage as well. Significant improvements in AOFAS scores have been reported for all currently used techniques, but none has emerged as the gold standard. Consequently, clinical research is focused on developing new interventions that demonstrate superiority over traditional techniques.

In this context, subendocondral regenerative treatment has gained interest. This approach involves the application of a bone marrow-derived scaffold combined with retrograde drilling in patients with subchondral cysts and intact cartilage or large OCLs of the ankle. This innovative surgical technique combines several procedures already validated in the literature, aiming to leverage their advantages and enhance overall efficacy.

First, it includes an intra-articular arthroscopic approach to assess cartilage status, remove loose bodies, and treat associated conditions such as synovitis, soft tissue impingement, exostoses, and osteophytes. After confirming the appropriate indication based on arthroscopic findings, a Kirschner wire is inserted retrogradely into the lesion under fluoroscopic guidance. Retrograde drilling is then performed using a dedicated reamer.

The novelty of this procedure lies in the placement of a hyaluronic scaffold enriched with bone marrow-derived cells beneath the cartilage, which is therefore not further disrupted. This fully biodegradable scaffold creates a favorable microenvironment for regeneration by supporting the adhesion of bone marrow-derived stem cells and their three-dimensional organization, thereby facilitating restoration of normal tissue anatomy. Large subchondral cysts have shown limited healing potential due to poor vitality of the subchondral bone and a lack of mesenchymal stem cells needed for lesion repair. Therefore, a cartilage scaffold enriched with bone marrow-derived cells may represent an important source of mesenchymal stem cells and promote cellular interaction and mechanical stability during the regenerative process.

This scaffold has been approved for the repair of chondral or osteochondral lesions; however, clinical and MRI outcomes following its subchondral placement in the presence of intact cartilage have not yet been described.

The aim of this pilot study is to evaluate the clinical and imaging outcomes of this innovative surgical technique for subchondral regenerative treatment, which involves the application of a scaffold enriched with bone marrow-derived cells combined with retrograde drilling in patients with subchondral cysts and intact cartilage or large osteochondral lesions of the talus.

Being tested
Osteochondral lesions treated with a scaffold enriched with bone marrow-derived cells at the subchondral level combined with retrograde drilling.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Osteochondral lesions treated with a scaffold enriched with bone marrow-derived cells at the subchondral level combined with retrograde drilling.Other

    First, the procedure includes an intra-articular arthroscopic approach to assess the condition of the cartilage, remove any loose bodies, and treat associated conditions such as synovitis, soft tissue impingement, exostoses, and osteophytes. After confirming the appropriate indication based on arthroscopic findings, a Kirschner wire is inserted retrogradely into the lesion under fluoroscopic guidance. Retrograde drilling is then performed using a dedicated reamer.

    The novelty of this procedure lies in the placement of a hyaluronic scaffold enriched with bone marrow-derived cells beneath the cartilage, which is therefore not further disrupted. This fully biodegradable scaffold creates a favorable microenvironment for regeneration by supporting the adhesion of bone marrow stem cells and their three-dimensional organization, thereby facilitating restoration of normal tissue anatomy. Large subchondral cysts have shown limited healing potential due to poor vitality of the subchondral bone a

Study groups in NCT07555899
Study groupRoleWhat they receive
Osteochondral lesions treated with a scaffold enriched with bone marrow-derived cells at the subchonExperimentalNot described
Receives: Other: Osteochondral lesions treated with a scaffold enriched with bone marrow-derived cells at the subchondral level combined with retrograde drilling.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate clinical and imaging outcomes in patients treated with retrograde drilling and application of bone marrow aspirate on a scaffold for the treatment of subchondral cysts with intact cartilage or large osteochondral lesions of the ankle at the d

    Measured: january 2026 - january 2028

Secondary outcomes (1)
  1. To evaluate MRI outcomes at 12 months using the T2 mapping protocol, which allows assessment of the biomechanical properties of the cartilage matrix, including collagen content and water percentage, by subjecting patients to MRI. The images will be indep

    Measured: january 2026 - january 2028

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2026
  2. Study start30 Jan 2026
  3. Primary completionJan 2028 (estimated)
  4. Study completionFeb 2028 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07555899
Sponsor's protocol ID
CASPARD
Status last verified
Apr 2026
First submitted
21 Apr 2026
Last updated
29 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Osteochondral lesions treated with a scaffold enriched with bone marrow-derived cells at the subchondral level combined with retrograde drilling. in people with Osteochondral Lesion, run by Istituto Ortopedico Rizzoli at 1 site in Italy.

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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 29 Apr 2026. 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 Italy. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Antotnio Mazzotti, MD PhD (+39 349 879 8863, antonio.mazzotti@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate clinical and imaging outcomes in patients treated with retrograde drilling and application of bone marrow aspirate on a scaffold for the treatment of subchondral cysts with intact cartilage or large osteochondral lesions of the ankle at the d (time frame: january 2026 - january 2028). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 29 Apr 2026.

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