Clinical trial NCT06311331: Prospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement (PROCLAIM)
Official title: Prospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement (PROCLAIM): a Multicenter, Single Arm, Prospective, Post-approval Study for Patients Who Received the Restor3d TTR Device to Evaluate Safety and Probable Benefit
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Avascular Necrosis of the Talus
Talar Osteochondral Defect of Ankle
Talar Dysfunction
Keywords: Avascular necrosis
Talus
Ankle joint
Lead sponsor: Restor3D
Sponsor class: INDUSTRY
Collaborators: name: OrthoCarolina Research Institute, Inc.
First posted: 2024-03-15
Enrollment: 50
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults (≥22 years of age) who will receive a restor3d Total Talus Replacement device under an approved HDE for one of the indications listed on the Instructions for Use (IFU) and who do not have a contraindication (see Inclusion and Exclusion Criteria)

Brief summary: This is a Humanitarian Device Exemption (HDE) approved device. The purpose of this study is to evaluate the continued safety and probable benefit of the restor3d Total Talus Replacement device in commercial use.


Eligibility criteria: Inclusion Criteria:

* ≥22 Years of Age
* Scheduled to receive TTR implant for one of the following indications:
* Avascular necrosis of the talus
* Avascular necrosis of the talus in addition to talar collapse, cysts or non-union
* Large, uncontained, unstable, or cystic talar osteochondral defects with risk of collapse or talar osteochondral defects not responsive to traditional treatments
* Nonunion following talar fracture or talar extrusion, unresponsive to more conservative treatments
* Have not had a prior Total Talus Replacement device implanted
* Not planning to receive bilateral Total Talus Replacement devices
* Subject signs a written informed consent form (ICF) prior to the surgical procedure

Exclusion Criteria:

* Surgical procedures other than those listed in the indications for use.
* Use of implant greater than 6 months from date of patient's preoperative CT scan.
* Degenerative changes in the tibiotalar, subtalar or talonavicular joints.
* Gross deformity in sagittal or coronal planes. More than 15 degrees of varus or valgus deformity in the coronal plane, or more than 50% subluxation anteriorly or posteriorly of the talus in the sagittal plane
* Patients with an active local or systemic infection.
* Osteonecrosis of the calcaneus, distal tibia or navicular.
* Known history of existing malignancy, or any systemic infection, local infection, or skin compromise at the surgical site.
* Blood supply limitations and previous infections that may prevent healing.
* Physical conditions that would eliminate adequate implant support or prevent healing, including inadequate soft tissue coverage.
* Conditions which may limit the patient's ability or willingness to restrict activities or follow directions postoperatively during the healing period.
* Presence of neurological deficit which would prevent patient postoperative compliance.
* Patients with foreign body sensitivity, suspected or documented material allergy or intolerance. Where material sensitivity is suspected, appropriate tests should be conducted, and sensitivity ruled out prior to implantation.

Primary outcomes:
measure: Proportion of participants who pass a composite of safety and probable benefit outcomes
timeFrame: At 5 years compared to baseline
Secondary outcomes:
measure: Change in perceived pain from baseline
timeFrame: At 5 years compared to baseline
measure: Change in Foot and Ankle Outcome Score (FAOS) Composite score from baseline
timeFrame: At 5 years compared to baseline
measure: Change in Foot and Ankle Outcome Score (FAOS) pain subscale score from baseline
timeFrame: At 5 years compared to baseline
measure: Change in Foot and Ankle Outcome Score (FAOS) other symptoms subscale score from baseline
timeFrame: At 5 years compared to baseline
measure: Change in Foot and Ankle Outcome Score (FAOS) activities of daily living (ADL) subscale score from baseline
timeFrame: At 5 years compared to baseline
measure: Change in Foot and Ankle Outcome Score (FAOS) sports/recreation subscale score from baseline
timeFrame: At 5 years compared to baseline
measure: Change in Foot and Ankle Outcome Score (FAOS) quality of life (QOL) subscale score from baseline
timeFrame: At 5 years compared to baseline
measure: Change in ankle range of motion (ROM) from baseline
timeFrame: At 5 years compared to baseline
measure: Proportion of procedure-related Serious Adverse Events
timeFrame: At 5 years compared to baseline
measure: Proportion of Adverse Events
timeFrame: At 5 years compared to baseline
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: OrthoCarolina Research Institute, Inc.
state: North Carolina
Study officials:
References: