Can a tiny metal plug fix painful ankle defects?
NCT ID NCT06522139
First seen Sep 04, 2026 · Last updated Sep 04, 2026
Summary
This trial tests whether a small metal implant, called the Episealer Talus, can relieve pain and improve function in people with a specific type of ankle cartilage damage. The study will enroll 20 adults aged 18 to 65 who have a focal defect on the talus bone and have not improved with conservative care. Participants will receive the implant and be followed for 60 months to measure changes in pain and symptoms, and to check how long the implant lasts.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Implantation of the Episealer Talus implant, a small metal device placed into the damaged area of the ankle bone.
- What this could lead to
- If it works, this could offer a durable option for people with ankle cartilage damage who have not improved with other treatments, potentially delaying or avoiding more invasive surgery.
- What could go wrong
- This is a small, early-stage study with only 20 participants, and results may not apply to everyone. The implant could loosen, cause pain, or require revision surgery, as seen in some earlier reports.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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20 people
The number who actually took part.
- Started
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Oct 2021
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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IRCCS Istituto Ortopedico Rizzoli
Bologna, 40136, Italy
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