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.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Antonio Mazzotti, PhD MD
- Telefonnummer: +39 349 879 8863
- E-Mail: antonio.mazzotti@ior.it
Studienorte
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Bologna, Italien
- Rekrutierung
- Istituto Ortopedico Rizzoli
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Kontakt:
- cesare Faldini, MD
- Telefonnummer: 051-6366669
- E-Mail: cesare.faldini@ior.it
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
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
Beschreibung
**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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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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.
Zeitfenster: february 2022 - march 2028
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february 2022 - march 2028
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Objective and subjective clinical and radiographic evaluation of the implant To assess ankle joint function using radiographic (X-ray) imaging
Zeitfenster: 36 months
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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. |
36 months
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To evaluate clinical parameters using: The American Orthopaedic Foot and Ankle Society (AOFAS) score The Manch
Zeitfenster: 36 months
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36 months
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- ASTot
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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