The restor3d Outcomes Registry

NCT07563803 | Not Yet Recruiting FDA Device

• 1 other identifier: restor3d-011
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

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

Arthropathy; Joint Replacement

Keywords

Knee arthroplasty; Hip arthroplasty; Ankle arthroplasty; Shoulder arthroplasty; restor3d

Outcome Measures

Primary Outcomes (1)

• Patient-Reported Implant Survivorship (all cohorts)

  Patient-reported implant survivorship as assessed through a sponsor-created post-market safety questionnaire, capturing implant-related adverse events including device malfunction, revision surgery, infection, wound complications, and life-threatening events.

  Pre-operative baseline through 5 years post-operatively (assessed at 6 weeks, 3 months, 6 months, 1, 2, 3, 4, and 5 years)

Secondary Outcomes (7)

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 6a Score (all cohorts)

  Pre-operative baseline through 5 years post-operatively (assessed at 6 weeks, 3 months, 6 months, 1, 2, 3, 4, and 5 years)

• Hospital Stay (all cohorts)

  6 weeks post-operatively

• Change in Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, Jr) Score (Knee cohort)

  Pre-operative baseline through 5 years post-operatively (assessed at 6 weeks, 3 months, 6 months, 1, 2, 3, 4, and 5 years)

• Change in Ankle Osteoarthritis Scale (AOS) Score (Foot & Ankle cohort)

  Pre-operative baseline through 5 years post-operatively (assessed at 6 weeks, 3 months, 6 months, 1, 2, 3, 4, and 5 years)

• Change in Hip Disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS, JR) Score (Hip cohort)

  Pre-operative baseline through 5 years post-operatively (assessed at 6 weeks, 3 months, 6 months, 1, 2, 3, 4, and 5 years)

Study Arms (4)

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.

Device: Patient-Specific Orthopedic Implant

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.

Device: Patient-Specific Orthopedic Implant

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.

Device: Patient-Specific Orthopedic Implant

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.

Device: Patient-Specific Orthopedic Implant

Interventions

Patient-Specific Orthopedic Implant DEVICE

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.

Foot & Ankle Cohort; Hip Cohort; Knee Cohort; Shoulder Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults who have received an FDA-cleared or approved restor3d patient-specific orthopedic implant and self-enroll via restor3d's patient engagement platforms or clinical research materials across the United States.

You may qualify if:

• Age ≥ 18 years
• Prescribed an FDA-cleared or approved orthopedic implant manufactured by restor3d, Inc.

You may not qualify if:

• 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
• Patient is receiving a restor3d implant outside of the defined implant cohorts
• Patient does not provide informed consent

Sponsors & Collaborators

• Restor3D: lead

MeSH Terms

Conditions

Joint Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: May 4, 2026
• Study Start (Estimated): May 31, 2026
• Primary Completion (Estimated): May 31, 2032
• Study Completion (Estimated): May 31, 2032
• Last Updated: May 4, 2026

Record last verified: 2026-04