The restor3d Outcomes Registry

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.

NCT Number	NCT07563803
Lead Sponsor	Restor3D
Conditions	Joint Replacement, Arthropathy
Enrollment	2,000 participants
Start Date	2026-09-30
Primary Completion	2032-09-30 (estimated)
Study Completion	2032-09-30 (estimated)
Updated on ClinicalTrials.gov	2026-07-07