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

NCT06522139 | Active Not Recruiting

• 1 other identifier: Epi-Talus
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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

Keywords

Talus Osteotomy; Osteochondral lesion; foot

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Sperimental

EXPERIMENTAL

Implantation of Episealer Talus Implant

Procedure: Implantation of Episealer Talus Implant

Interventions

Implantation of Episealer Talus Implant PROCEDURE

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.

Sperimental

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stefano Zaffagnini: lead

Study Sites (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: October 14, 2021
• Primary Completion: September 12, 2023
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

IT (1)