Recruiting

Restor3D

Sponsor:

Restor3D

Code:

NCT07563803

Conditions

Joint Replacement

Arthropathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Patient-Specific Orthopedic Implant

Study Details

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.

Conditions

Joint Replacement

Arthropathy

Study ID

NCT07563803

Start date

Oct 15, 2026

Status verified date

Oct, 2026

Completion date

Oct 15, 2032

Anticipated

Primary completion date

Oct 15, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

2250 participants

Anticipated

Interventions and Outcome Measures

Arms

Knee Cohort

Adults who have received an FDA-cleared restor3d patient-specific knee implant (total knee replacement, unicompartmental knee replacement). Participants complete ePRO surveys pre-operatively and at 6 weeks, 3 months, 6 months, and annually through 5 years post-operatively.

Hip Cohort

Adults who have received an FDA-cleared restor3d patient-specific hip implant. Participants complete ePRO surveys pre-operatively and at 6 weeks, 3 months, 6 months, and annually through 5 years post-operatively.

Foot & Ankle Cohort

Adults who have received an FDA-cleared restor3d patient-specific ankle implant (total ankle replacement) or an FDA-approved restor3d patient-specific total talus replacement. Participants complete ePRO surveys pre-operatively and at 6 weeks, 3 months, 6 months, and annually through 5 years post-operatively.

Shoulder Cohort

Adults who have received an FDA-cleared restor3d patient-specific shoulder implant (reverse total shoulder arthroplasty). Participants complete ePRO surveys pre-operatively and at 6 weeks, 3 months, 6 months, and annually through 5 years post-operatively.

Interventions

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.

Primary outcome measure

  • Patient-Reported Implant Survivorship (all cohorts) [ Time Frame: Pre-operative baseline through 5 years post-operatively (assessed at 6 weeks, 3 months, 6 months, 1, 2, 3, 4, and 5 years) ]

Central Contacts and Locations

Central contacts

Kathryn Jackson

984-248-0533clinicalresearch@restor3d.com

Locations

Restor3D

Recruiting

Durham, North Carolina, United States, 27709

Contacts

Kathryn Jackson

984-248-0533clinicalresearch@restor3d.com

More Information

Sponsor

Restor3D

Last update posted

Oct 27, 2026

Last verified

Oct, 2026

Keywords

  • Knee arthroplasty
  • Hip arthroplasty
  • Ankle arthroplasty
  • Shoulder arthroplasty
  • restor3d

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-28. This information was provided to ClinicalTrials.gov by Restor3D on 2026-10-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.