MedTrace Logo

The restor3d Outcomes Registry

NCT07563803 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2026-07-07

No results posted yet for this study

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.

Conditions

  • Joint Replacement
  • Arthropathy

Interventions

DEVICE

Patient-Specific Orthopedic Implant

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.

Sponsors & Collaborators

  • Restor3D

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2032-09-30
Completion
2032-09-30
FDA Device
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07563803 on ClinicalTrials.gov