Osteochondral DefectNCT06522139
Clinical Outcome After Episealer Talus Implant in Treatment of Osteochondral Lesion of the Talus
A study testing Implantation of Episealer Talus Implant in people with Osteochondral Defect, run by Stefano Zaffagnini at 1 site in Italy.
Trial summary
Autologous Chondrocyte Implantation (ACI) is an appealing technique whereby cartilage is harvested from the joint in a first operation. This biopsy is processed, individual cells are freed and cultivated and, in a second procedure, injected into the defect that has been covered by a periosteal graft). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Osteochondral Defect
- What is being tested?
- Implantation of Episealer Talus Implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 14 Oct 2021to Aug 2027
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteochondral lesion (both primary and secondary lesions) ⌀ 10-15 mm on the medial or lateral talar dome
- age between 18 and 65 years
- BMI < 35
- patients who have given their willingness to reach the Institute for checkups.
- patients previously treated with conservative therapies, which proved unsuccessful
Who cannot join
- non-focal defect
- on-going infection in the ankle joint
- inflammatory arthritis or radiographic osteoarthritis in the ankle joint (=no joint space narrowing) Osteophytes without joint space narrowing (=Gr1 (van Dijk classification)) is not a contra indication.
- sensitivity to cobalt-chrome alloys and titanium materials
- inadequate bone stock where the Episealer is to be inserted
- existing prosthesis in the area of treatment or opposing surface
Show all 20Show fewer
- osteochondral lesion on opposing tibial surface
- pain of unknown etiology
- demineralised bone
- instability. Instability is defined as recurrent giving way with or without laxity
- severe malalignment in the ankle joint >5 degrees malalignment as compared to the contralateral ankle joint, as measured on the standing X-Ray
- Ipsilateral symptomatic foot, knee or hip disease which affects the mobility of the patient
- other diseases or medication that may affect the bone anchoring of the Episealer
- uncooperative patient that is not willing to follow instructions
- muscular insufficiency
- vascular insufficiency
- medical, hormonal, hematological, immunological or metabolic illnesses
- Smoking
- Pregnancy
- Diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Autologous Chondrocyte Implantation (ACI) is an appealing technique whereby cartilage is harvested from the joint in a first operation. This biopsy is processed, individual cells are freed and cultivated and, in a second procedure, injected into the defect that has been covered by a periosteal graft). A second generation includes a matrix (MACI) into which the cells are injected/cultivated. Recently, collagen membranes are used to cover the cells or cover a micro-fractured defect. Good results have been reported although return to previous sports remains a challenge . Long term results are lacking. More important is the fact that these treatments are directed towards restoring the articular cartilage whereas the patient's symptoms are generated by the bone and not the cartilage.
Treatment of an OCD with a small metallic implant has been tested in recent years. Results have been promising by some reports, while a high revision rates was reported by others. A recent 2-8 years follow-up study revealed a survival rate of 95 %
- Conditions
- Osteochondral Defect
- Being tested
- Implantation of Episealer Talus Implant
- Keywords
- Talus Osteotomy, Osteochondral lesion, foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of Episealer Talus ImplantProcedure or surgery
Subjects will be on study for up to 60 months after their talus implant surgery. Treatment: Implantation of Episealer Talus Implant Follow-up: 60 months The total duration of the study is expected to be 75 months. 12 months for subject recruitment, 60 for final subject follow-up and 3 for data analysis and production of the final report.
| Study group | Role | What they receive |
|---|---|---|
| Sperimental | Experimental | Implantation of Episealer Talus Implant Receives: Procedure: Implantation of Episealer Talus Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
FOOT AND ANKLE OUTCOME SCORE -symptoms
The FAOS (Foot and Ankle outcome score) is a 42-item questionnaire, 7 items for symptoms
Measured: after 12 months from the intervention
Implant survival
Implant survival rate at 60 months follow-up
Measured: after 5 years
FOOT AND ANKLE OUTCOME SCORE - pain
The FAOS (Foot and Ankle outcome score) is a 42-item questionnaire, 9 for pain
Measured: after 12 months from the intervention
FOOT AND ANKLE OUTCOME SCORE -symptoms
The FAOS (Foot and Ankle outcome score) is a 42-item questionnaire, 7 items for symptoms
Measured: after 24 months from the intervention
FOOT AND ANKLE OUTCOME SCORE - Pain
The FAOS (Foot and Ankle outcome score) is a 42-item questionnaire, 9 for pain
Measured: after 24 months from the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start14 Oct 2021
- Primary completion12 Sep 2023
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteochondral DefectStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stefano Zaffagnini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stefano Zaffagnini, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522139
- Sponsor's protocol ID
- Epi-Talus
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2024
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome After Episealer Talus Implant in Treatment of Osteochondral Lesion of the Talus
- ClinicalTrials.gov ID
- NCT06522139
- Acronym / sponsor ID
- Epi-Talus
- Conditions
- Osteochondral Defect
- Keywords
- Talus Osteotomy, Osteochondral lesion, foot
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Stefano ZaffagniniUniversity, hospital or other
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 12 Sep 2023 (actual)
- Study completion
- Aug 2027 (estimated)
- First posted
- 26 Jul 2024 (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.
Autologous Chondrocyte Implantation (ACI) is an appealing technique whereby cartilage is harvested from the joint in a first operation. This biopsy is processed, individual cells are freed and cultivated and, in a second procedure, injected into the defect that has been covered by a periosteal graft). A second generation includes a matrix (MACI) into which the cells are injected/cultivated. Recently, collagen membranes are used to cover the cells or cover a micro-fractured defect. Good results have been reported although return to previous sports remains a challenge . Long term results are lacking. More important is the fact that these treatments are directed towards restoring the articular cartilage whereas the patient's symptoms are generated by the bone and not the cartilage.
Treatment of an OCD with a small metallic implant has been tested in recent years. Results have been promising by some reports, while a high revision rates was reported by others. A recent 2-8 years follow-up study revealed a survival rate of 95 %
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sperimental | Experimental | Procedure: Implantation of Episealer Talus ImplantImplantation of Episealer Talus Implant |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Osteochondral lesion (both primary and secondary lesions) ⌀ 10-15 mm on the medial or lateral talar dome
- age between 18 and 65 years
- BMI < 35
- patients who have given their willingness to reach the Institute for checkups.
- patients previously treated with conservative therapies, which proved unsuccessful
Key exclusion criteria (20 listed)
- non-focal defect
- on-going infection in the ankle joint
- inflammatory arthritis or radiographic osteoarthritis in the ankle joint (=no joint space narrowing) Osteophytes without joint space narrowing (=Gr1 (van Dijk classification)) is not a contra indication.
- sensitivity to cobalt-chrome alloys and titanium materials
- inadequate bone stock where the Episealer is to be inserted
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 |
|---|---|---|
| Implantation of Episealer Talus ImplantSubjects will be on study for up to 60 months after their talus implant surgery. Treatment: Implantation of Episealer Talus Implant Follow-up: 60 months The total duration of the study is expected to be 75 months. 12 months for subject recruitment, 60 for final subject follow-up and 3 for data analysis and production of the final report. | Procedure or surgery | Sperimental |
Primary outcome
FOOT AND ANKLE OUTCOME SCORE -symptoms
Time frame: after 12 months from the intervention
The FAOS (Foot and Ankle outcome score) is a 42-item questionnaire, 7 items for symptoms
Implant survival
Time frame: after 5 years
Implant survival rate at 60 months follow-up
FOOT AND ANKLE OUTCOME SCORE - pain
Time frame: after 12 months from the intervention
The FAOS (Foot and Ankle outcome score) is a 42-item questionnaire, 9 for pain
FOOT AND ANKLE OUTCOME SCORE -symptoms
Time frame: after 24 months from the intervention
The FAOS (Foot and Ankle outcome score) is a 42-item questionnaire, 7 items for symptoms
FOOT AND ANKLE OUTCOME SCORE - Pain
Time frame: after 24 months from the intervention
The FAOS (Foot and Ankle outcome score) is a 42-item questionnaire, 9 for pain
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
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A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of Episealer Talus Implant in people with Osteochondral Defect, run by Stefano Zaffagnini 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 5 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 4 Sep 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?
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?
FOOT AND ANKLE OUTCOME SCORE -symptoms (time frame: after 12 months from the intervention). The study lists 5 primary outcomes in all. 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 4 Sep 2026.