Overview

The restor3d Outcomes Registry is a prospective, longitudinal, decentralized study designed to capture patient-reported outcomes (PROs) from adults who have received an FDA-cleared or approved restor3d patient-specific orthopedic implant. Using a master protocol framework, the study enrolls patients across multiple joint cohorts (knee, hip, foot \& ankle, shoulder) under a single protocol, with joint-specific details governed by individual appendices. Participants self-enroll and complete electronic PRO surveys (ePROs) before surgery and at 6 weeks, 3 months, 6 months, and annually through 5 years post-operatively, all remotely, with no required in-person visits. The study aims to quantify changes in pain, function, quality of life, and satisfaction over time, and to establish real-world outcome benchmarks for patient-specific orthopedic implants.

Eligibility

Master Protocol Inclusion Criteria:

• Age ≥ 18 years
• Prescribed an FDA-cleared or approved orthopedic implant manufactured by restor3d, Inc.

Master Protocol Exclusion Criteria:

• Patient is receiving an implant not manufactured by restor3d
• Patient is receiving a restor3d implant that is not FDA-cleared or approved
• Patient lives outside the United States
• Patient is receiving a restor3d implant that does not use a patient-specific plan, instrumentation or implant
• Patient is non-English-speaking (to ensure accurate comprehension and completion of the surveys)
• Patient is receiving a restor3d implant outside of the defined implant cohorts
• Patient does not provide informed consent