NCT Number: NCT07563803
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Master Protocol Inclusion Criteria:
Master Protocol Exclusion Criteria:
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.
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.
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.
Time frame: 6 weeks post-operatively
Length of hospital stay (in nights) via non-validated patient-reported outcome measure.
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.
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
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 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.
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).
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 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).
Restor3D
Industry
The restor3d Outcomes Registry: Tracking Patient Recovery After Joint Replacement
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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