Actively Recruiting
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.
Led by Istituto Ortopedico Rizzoli · Updated on 2026-05-06
26
Participants Needed
1
Research Sites
159 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new patient-specific 3D-printed talar implant designed to replace the talus bone for treating talar avascular necrosis and severe bone loss or compromise in the ankle. This implant offers an alternative to other surgical procedures by aiming to preserve joint function. Developed at the Rizzoli Orthopaedic Institute, the study focuses on assessing outcomes of this custom-made device over time in patients requiring total ankle and talar replacement. The device combines components from a FAR-type ankle prosthesis with a total talus replacement implant, customized for each patient using additive manufacturing technology and made from a hypoallergenic titanium alloy treated with a nitriding process. The implant is inserted using custom cutting guides to minimize damage to surrounding bone, ligament, and tendon structures, aiming to preserve ankle function as much as possible. Participants will be monitored at multiple intervals up to 36 months after surgery, including evaluations at 1, 3, 6, 12, 24, and 36 months. Researchers will assess implant survival, ankle joint function using clinical scores such as the American Orthopaedic Foot and Ankle Society (AOFAS) score, and radiographic imaging. The study involves regular follow-ups, clinical and radiographic examinations, and questionnaires to track outcomes and implant safety.
CONDITIONS
Brief Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 month
Participants undergo surgical treatment using a custom-made device for total ankle and talar replacement, followed by immediate post-operative care.
1 surgery visit and several post-operative visits
Duration - Up to 36 months
Participants are monitored with clinical and radiographic evaluations to assess implant survival and ankle joint function.
Visits at 1, 3, 6, 12, 24, and 36 months post-surgery
Trial Site Locations
Total: 1 location
1
Istituto Ortopedico Rizzoli
Bologna, Italy
Actively Recruiting
Research Team
A
Antonio Mazzotti, PhD MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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