Clinical Outcome After Episealer Talus Implant in Treatment of Osteochondral Lesion of the Talus (NCT06522139) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Clinical Outcome After Episealer Talus Implant in Treatment of Osteochondral Lesion of the Talus
Italy20 participantsStarted 2021-10-14
Plain-language 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). 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 %
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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 i…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.