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NCT Number: NCT06522139

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 %

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Osteochondral Defect

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. FOOT AND ANKLE OUTCOME SCORE -symptoms

    Time frame: after 12 months from the intervention

    The FAOS (Foot and Ankle outcome score) is a 42-item questionnaire, 7 items for symptoms

  2. Implant survival

    Time frame: after 5 years

    Implant survival rate at 60 months follow-up

  3. FOOT AND ANKLE OUTCOME SCORE - pain

    Time frame: after 12 months from the intervention

    The FAOS (Foot and Ankle outcome score) is a 42-item questionnaire, 9 for pain

  4. FOOT AND ANKLE OUTCOME SCORE -symptoms

    Time frame: after 24 months from the intervention

    The FAOS (Foot and Ankle outcome score) is a 42-item questionnaire, 7 items for symptoms

  5. FOOT AND ANKLE OUTCOME SCORE - Pain

    Time frame: after 24 months from the intervention

    The FAOS (Foot and Ankle outcome score) is a 42-item questionnaire, 9 for pain

Sponsors and collaborators

Lead sponsor

Stefano Zaffagnini

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2027
First posted
Jul 26, 2024
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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