Status:
ACTIVE_NOT_RECRUITING
Clinical Outcome After Episealer Talus Implant in Treatment of Osteochondral Lesion of the Talus
Lead Sponsor:
Stefano Zaffagnini
Conditions:
Osteochondral Defect
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 cultiva...
Eligibility Criteria
Inclusion
- 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
- 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 illnesses
- Smoking
- Pregnancy
- Diabetes
Key Trial Info
Start Date :
October 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06522139
Start Date
October 14 2021
End Date
August 1 2027
Last Update
August 1 2025
Active Locations (1)
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1
IRCCS Istituto Ortopedico Rizzoli
Bologna, Italy, 40136