Custom 3D-Printed ankle implant offers new hope for severe bone loss

NCT ID NCT07569848

Disease control Sponsor: Istituto Ortopedico Rizzoli Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study is testing a custom-made, 3D-printed titanium implant that replaces the ankle joint and talus bone in people with severe bone loss or damage. The implant is designed to fit each patient perfectly and aims to preserve ankle function while reducing surgical harm to surrounding tissues. Researchers will follow 26 patients for up to 3 years to see how well the implant holds up and how it affects pain and mobility.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: custom-made 3D-printed titanium ankle and talar implant
What this could lead to: If successful, this custom implant could offer a new option for people with severe ankle bone loss, potentially preserving joint function and avoiding more invasive surgeries like fusion or amputation.
What could go wrong: This is a very small pilot study with only 26 participants, so results may not apply to everyone. The implant is new and long-term outcomes are unknown; risks include implant failure, infection, or need for additional surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 26 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2022

Expected to finish

Mar 2031

An estimate. End dates often move.

Lead sponsor

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.

Who is studied

Patients with degenerative pathology of the tibiotalar joint associated with significant bone loss or talar bone compromise, for whom further diagnostic evaluation using CT imaging is required to determine a potential surgical indication, will be included in this pilot study. In the case of confirmation of the indication for total ankle replacement with total talar substitution, patients will undergo a CT scan of the contralateral ankle for implant design (as per standard clinical practice for the development of patient-specific implants) and surgical planning. Following surgery, patients will be evaluated at subsequent follow-up visits according to routine clinical practice. All study procedures will be conducted at Clinic I of the Rizzoli Orthopaedic Institute (patient selection and enrolment, and diagnostic imaging). The study population consists of patients aged between 35 and 75 years affected by degenerative disease of the tibiotalar joint associated with severe bone loss or tala

Ages

35 to 75 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

\*\*INCLUSION CRITERIA:\*\* 1. Male or female patients aged between 35 and 75 years. 2. Pathology of the tibiotalar joint requiring surgical intervention with prosthetic replacement. 3. Severe cases of bone loss or talar bone compromise. 4. Customisation performed at the Rizzoli Orthopaedic Institute. 5. Signed informed consent for participation in the study. 6. Patients must be prepared and motivated to comply with preoperative and postoperative investigations, rehabilitation protocols, follow-up schedules, and study questionnaires. \*\*EXCLUSION CRITERIA:\*\* 1. Patients unable to understand or provide informed consent. 2. Pregnant women. 3. Body mass index (BMI) \> 40. 4. Refusal to sign the informed consent form for study participation. 5. Substance abuse or psychological disorders that may interfere with adherence to rehabilitation and postoperative assessment protocols. 6. Known hypersensitivity to device materials. 7. Active or suspected latent infection in or around the affected ankle joint. 8. Previous orthopaedic surgery on the lower limbs within the last year, or planned orthopaedic surgery within one year (excluding ankle replacement). 9. Presence of neuromuscular or neurosensory deficits limiting the ability to assess device safety and efficacy. 10. Diagnosis of systemic disease (e.g., systemic lupus erythematosus) or metabolic disorder (e.g., Paget's disease of bone) leading to progressive bone deterioration. 11. Immunosuppression or excessive steroid therapy beyond physiological requirements (e.g., \>30 days). 12. Pregnant and/or fertile women.

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Conditions

The condition(s) this trial relates to.

arthropathy osteoarthritis osteochondritis of tarsal/metatarsal bone

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ankle arthritis Ankle replacement Arthrosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Custom 3D-Printed ankle implant offers new hope for severe bone loss

What the study statuses mean