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

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 Overview

• Status: Active, not recruiting
• Conditions: Osteochondral Defect
• Intervention / Treatment: Procedure: Implantation of Episealer Talus Implant

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40136
    • IRCCS Istituto Ortopedico Rizzoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sperimental; Implantation of Episealer Talus Implant	Procedure: Implantation of Episealer Talus Implant; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FOOT AND ANKLE OUTCOME SCORE -symptoms	The FAOS (Foot and Ankle outcome score) is a 42-item questionnaire, 7 items for symptoms	after 12 months from the intervention
Implant survival	Implant survival rate at 60 months follow-up	after 5 years
FOOT AND ANKLE OUTCOME SCORE - pain	The FAOS (Foot and Ankle outcome score) is a 42-item questionnaire, 9 for pain	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	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	after 24 months from the intervention

Collaborators and Investigators

• Sponsor: Stefano Zaffagnini

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2021
• Primary Completion (Actual): September 12, 2023
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: July 22, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: foot; Osteochondral lesion; Talus Osteotomy
• Other Study ID Numbers: Epi-Talus

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No