An observational study in Joint Replacement and Arthropathy, sponsored by Restor3D. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Restor3D · Observational
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.
386 studies on the registry are indexed under Joint Diseases; 64 are open to participants now.
This study's planned enrollment of 2,250 is above the median of 86 across 116 observational studies indexed under Joint Diseases.
Browse Joint Diseases studies →Restor3D is the lead sponsor of 24 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Master Protocol Inclusion Criteria:
Master Protocol Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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.
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.
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)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 6a Score (all cohorts)
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.
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)
Hospital Stay (all cohorts)
Length of hospital stay (in nights) via non-validated patient-reported outcome measure.
Time frame: 6 weeks post-operatively
Change in Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, Jr) Score (Knee cohort)
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.
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)
Change in Ankle Osteoarthritis Scale (AOS) Score (Foot & Ankle cohort)
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
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)
Change in Hip Disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS, JR) Score (Hip cohort)
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.
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)
Change in Single Assessment Numeric Evaluation (SANE) score (Shoulder cohort)
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).
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)
Change in American Shoulder and Elbow Surgeons (ASES) score (Shoulder cohort)
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.
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)
Started Oct 2026 (actual). Primary completion is estimated for Oct 2032, 72 months after the start.
Of 58 observational studies under Joint Diseases, half reached primary completion within 62 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 153. This study's planned 72 months is above that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 27, 2026: start Sep 2026 → Oct 2026, primary completion Sep 2032 → Oct 2032 and completion Sep 2032 → Oct 2032.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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