Clinical Outcome After Episealer Talus Implant in Treatment of Osteochondral Lesion of the Talus

Stefano Zaffagnini

Status

Active, not recruiting

Conditions

Osteochondral Defect

Treatments

Procedure: Implantation of Episealer Talus Implant

Study type

Interventional

Funder types

Other

Identifiers

NCT06522139

Epi-Talus

Details and patient eligibility

About

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 %

Enrollment

20 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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 illnesses
Smoking
Pregnancy
Diabetes