Restor3D
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.
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…
FDA-cleared or approved patient-specific orthopedic implant manufactured by restor3d, Inc. Implants are individually designed using patient imaging data and 3D-printing technology to match the patient's unique anatomy. This study does not involve any experimental procedures; implantation occurs as part of standard clinical care prior to and independent of study enrollment.
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