The restor3d Outcomes Registry
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRestor3D
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Prescribed an FDA-cleared or approved orthopedic implant manufactured by restor3d, Inc.
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Patient-Specific Orthopedic Implant
DeviceFDA-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.
Treatment groups
2,250 Participants
are divided into 4 treatment groupsGroup A: Knee Cohort1 intervention
Group B: Hip Cohort1 intervention
Group C: Foot & Ankle Cohort1 intervention
Group D: Shoulder Cohort1 intervention
Trial outcomes
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.
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)Secondary outcomes
1
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)2
Hospital Stay (all cohorts)
Length of hospital stay (in nights) via non-validated patient-reported outcome measure.
Time frame
6 weeks post-operatively3
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)4
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)Locations
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: