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NCT Number: NCT07569848

Outcomes of Surgical Treatment Using a Custom-made Device for Total Ankle and Talar Replacement in the Management of Severe Cases of Bone Loss or Bone Compromise: a Pilot Study.

On February 17th, 2021, the FDA officially approved the use of the first patient-specific 3D-printed talar implant for compassionate use. This is a patient-specific talar spacer designed to completely replace the talus for the treatment of talar avascular necrosis. The implant represents an alternative to other surgical procedures that allows joint preservation.

Recently, at the First Clinic of the Rizzoli Orthopaedic Institute, a prosthetic device has been developed that combines the tibial and meniscal components of a FAR-type ankle prosthesis (Adler Ortho) with a total talus replacement implant. Since the device is patient-specific and implanted using custom-made cutting guides, it reduces surgical invasiveness on surrounding bone structures as well as on ligamentous and tendinous structures, thereby preserving ankle function as much as possible.

The customization is based on a next-generation prosthetic model produced using additive manufacturing technology and featuring hypoallergenic properties, as it is made of a titanium alloy and treated with a nitriding process.

The aim of this study is therefore to evaluate the outcomes of this prosthetic device over time.

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Key information

Conditions

Arthrosis Ankle Arthritis Ankle Replacement Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Ortopedico Rizzoli

Bologna, Italy

Location status: Recruiting

Location contact

cesare Faldini, MD

CONTACT

[email protected]

051-6366669

Who can participate

Healthy volunteers accepted: No

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

**INCLUSION CRITERIA:**

  • Male or female patients aged between 35 and 75 years.
  • Pathology of the tibiotalar joint requiring surgical intervention with prosthetic replacement.
  • Severe cases of bone loss or talar bone compromise.
  • Customisation performed at the Rizzoli Orthopaedic Institute.
  • Signed informed consent for participation in the study.
  • Patients must be prepared and motivated to comply with preoperative and postoperative investigations, rehabilitation protocols, follow-up schedules, and study questionnaires.

**EXCLUSION CRITERIA:**

  • Patients unable to understand or provide informed consent.
  • Pregnant women.
  • Body mass index (BMI) > 40.
  • Refusal to sign the informed consent form for study participation.
  • Substance abuse or psychological disorders that may interfere with adherence to rehabilitation and postoperative assessment protocols.
  • Known hypersensitivity to device materials.
  • Active or suspected latent infection in or around the affected ankle joint.
  • Previous orthopaedic surgery on the lower limbs within the last year, or planned orthopaedic surgery within one year (excluding ankle replacement).
  • Presence of neuromuscular or neurosensory deficits limiting the ability to assess device safety and efficacy.
  • Diagnosis of systemic disease (e.g., systemic lupus erythematosus) or metabolic disorder (e.g., Paget's disease of bone) leading to progressive bone deterioration.
  • Immunosuppression or excessive steroid therapy beyond physiological requirements (e.g., >30 days).
  • Pregnant and/or fertile women.

Treatment and study plan

Primary outcomes

  1. To evaluate the survival of the FAR implant in a cohort of patients treated at the Orthopaedic and Traumatology Clinic I of the Rizzoli Orthopaedic Institute, with follow-up at 1, 3, 6, 12, 24, and 36 months.

    Time frame: february 2022 - march 2028

Secondary outcomes

  1. Objective and subjective clinical and radiographic evaluation of the implant To assess ankle joint function using radiographic (X-ray) imaging

    Time frame: 36 months

    Study procedures include:

    Training of surgeons and research staff on the new procedure. Acquisition of a patient list based on radiographic criteria obtained during routine outpatient procedures.

    Patient screening period. Assessment of patient eligibility for study inclusion. Functional and clinical evaluation of the prosthesis in collaboration with the Orthopaedic and Traumatology Clinic I (Rizzoli Orthopaedic Institute).

    Patient enrolment and informed consent collection. Preoperative procedures, including acquisition of diagnostic imaging (weight-bearing AP and lateral X-rays, clinical scores, preoperative CT scan). FFor each patient, a computer-based virtual prosthetic implantation will be performed, and a patient-specific talar component will be manufactured for total bone replacement.

    Surgical procedure involving total ankle replacement using the patient-specific prosthetic device with total talar substitution.

  2. To evaluate clinical parameters using: The American Orthopaedic Foot and Ankle Society (AOFAS) score The Manch

    Time frame: 36 months

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio Mazzotti, PhD MD

CONTACT

[email protected]

+39 349 879 8863

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Important dates

Study start
2022
Primary completion
2028
Study completion
2031
First posted
May 6, 2026
Registry last updated
May 6, 2026

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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