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The restor3d Outcomes Registry
The restor3d Outcomes Registry: Tracking Patient Recovery After Joint Replacement
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- Patient-Specific Orthopedic Implant (device)
Sponsor: Restor3D · Participants: 2,250 · Started: Oct 15, 2026
Contact the study team
- Kathryn Jackson · Phone: 984-248-0533
Official record on ClinicalTrials.gov — NCT07563803
Locations in the U.S.
| North Carolina | Restor3D, Durham |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.