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NCT Number: NCT07563803

The restor3d Outcomes Registry

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.

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Key information

Conditions

Joint Replacement Arthropathy Joint Diseases Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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)

    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.

Secondary outcomes

  1. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 6a Score (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)

    Improvement in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 6a score evaluated by comparing postoperative scores to baseline. Raw scores range from 6 to 30 on a 5-point Likert scale. Higher raw scores indicate greater severity of depressive symptoms.

  2. Hospital Stay (all cohorts)

    Time frame: 6 weeks post-operatively

    Length of hospital stay (in nights) via non-validated patient-reported outcome measure.

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

    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)

    Improvement in Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, Jr) evaluated by comparing postoperative scores to baseline. KOOS JR is a 7 item scale where items are originally rated on a 5-point Likert scale (0 to 4), creating a raw sum score (0-28), which is then converted into the 0-100 interval score. A higher score indicates better joint.

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

    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)

    Improvement in Ankle Osteoarthritis Scale (AOS) evaluated by comparing postoperative scores to baseline. The AOS consists of 18 items divided into two subscales (9-item Pain subscale and 9-item Disability subscale), typically using a 100-mm Visual Analog Scale (VAS) for each answer. Higher scores indicate a worse condition, meaning more pain and greater disability

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

    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)

    Improvement in hip disability and osteoarthritis was assessed using the Hip disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS, JR.). The HOOS, JR is a 6-item patient-reported outcome measure assessing pain and functional limitations related to the hip. Each item is scored from 0 to 4, with a total raw score ranging from 0 to 24. The raw score is converted to a standardized score ranging from 0 to 100, where 0 represents the worst possible hip status and 100 represents the best possible hip status. Improvement is evaluated by comparing postoperative HOOS, JR scores to baseline scores, with higher postoperative scores indicating better hip-related health and function.

  6. Change in Single Assessment Numeric Evaluation (SANE) score (Shoulder cohort)

    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)

    Improvement in Single Assessment Numeric Evaluation (SANE) score evaluated by comparing postoperative scores to baseline. The SANE score is a patient-reported outcome measure where patients rate their shoulder on a 0-100% scale (100% being normal).

  7. Change in American Shoulder and Elbow Surgeons (ASES) score (Shoulder cohort)

    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)

    Improvement in the American Shoulder and Elbow Surgeons (ASES) score evaluated by comparing postoperative scores to baseline scores. The ASES score is a 100-point patient-reported outcome measure assessing shoulder pain and function. It comprises a pain component based on a 0-10 pain visual analog scale, contributing 50 points, and a functional component based on 10 activities of daily living (ADL) items, contributing 50 points. The total ASES score ranges from 0 to 100, with 0 representing the worst possible shoulder status and 100 representing the best possible shoulder status. Higher scores indicate less pain and better shoulder function.

Sponsors and collaborators

Lead sponsor

Restor3D

Industry

Registry information

Official study title

The restor3d Outcomes Registry: Tracking Patient Recovery After Joint Replacement

Important dates

Study start
2026
Primary completion
2032
Study completion
2032
First posted
May 4, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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