Arthropathy, Joint Replacement
Conditions
Keywords
Knee arthroplasty, Hip arthroplasty, Ankle arthroplasty, Shoulder arthroplasty, restor3d
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.
Interventions
DEVICEPatient-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
Restor3D
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 * Patient is receiving a restor3d implant outside of the defined implant cohorts * Patient does not provide informed consent * Plus additional cohort-specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Implant Survivorship (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) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
| Hospital Stay (all cohorts) | 6 weeks post-operatively | Length of hospital stay (in nights) via non-validated patient-reported outcome measure. |
| 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) | 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. |
| 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) | 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 |
| 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) | Improvement in Hip Disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS, JR) evaluated by comparing postoperative scores to baseline. The HOOS JR is a 6-item patient-reported survey used to evaluate hip health, with scores ranging from 0 to 100, which higher scores indicating better health. |
| Change in Single Assessment Numeric Evaluation (SANE) score (Shoulder cohort) | 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). |
| Change in American Shoulder and Elbow Surgeons (ASES) score (Shoulder cohort) | 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 American Shoulder and Elbow Surgeons (ASES) score evaluated by comparing postoperative scores to baseline. The ASES score is a 100-point patient-reported outcome measure used to evaluate shoulder pain and function. It combines a 0-10 pain visual analog scale (weighted 50%) and 10 activities of daily living (ADL) questions (weighted 50%). Scores range from 0 (worst) to 100 (best). |
Outcome results
None listed