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.

NCT07569848 | Recruiting

• 1 other identifier: ASTot
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arthrosis; Ankle Arthritis; Ankle Replacement

Outcome Measures

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.

  february 2022 - march 2028

Secondary Outcomes (2)

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

  36 months

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

  36 months

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, Italy

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Antonio Mazzotti, PhD MD

CONTACT

+39 349 879 8863; antonio.mazzotti@ior.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 6, 2026
• Study Start: February 11, 2022
• Primary Completion (Estimated): February 11, 2028
• Study Completion (Estimated): March 1, 2031
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

IT (1)