| NCT ID | NCT07563803 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Restor3D |
| Condition | Joint Replacement |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,250 participants |
| Start Date | 2026-10-15 |
| Primary Completion | 2032-10-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,250 participants in total. It began in 2026-10-15 with a primary completion date of 2032-10-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07563803 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Joint Replacement. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07563803 currently recruiting?
Yes, NCT07563803 is actively recruiting participants. Contact the research team at clinicalresearch@restor3d.com for enrollment information.
Where is the NCT07563803 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT07563803 clinical trial?
NCT07563803 is sponsored by Restor3D. The trial plans to enroll 2,250 participants.