The restor3d Outcomes Registry
6 juillet 2026 mis à jour par: Restor3D
The restor3d Outcomes Registry: Tracking Patient Recovery After Joint Replacement
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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Observationnel
Inscription (Estimé)
2000
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La description
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 exclusion criteria
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Knee Cohort
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.
|
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.
|
|
Hip Cohort
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.
|
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.
|
|
Foot & Ankle Cohort
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.
|
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.
|
|
Shoulder Cohort
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.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Patient-Reported Implant Survivorship (all cohorts)
Délai: 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.
|
Pre-operative baseline through 5 years post-operatively (assessed at 6 weeks, 3 months, 6 months, 1, 2, 3, 4, and 5 years)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 6a Score (all cohorts)
Délai: 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.
|
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)
Délai: 6 weeks post-operatively
|
Length of hospital stay (in nights) via non-validated patient-reported outcome measure.
|
6 weeks post-operatively
|
|
Change in Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, Jr) Score (Knee cohort)
Délai: 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.
|
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)
Délai: 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
|
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)
Délai: 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.
|
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)
Délai: 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).
|
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)
Délai: 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).
|
Pre-operative baseline through 5 years post-operatively (assessed at 6 weeks, 3 months, 6 months, 1, 2, 3, 4, and 5 years)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
30 septembre 2026
Achèvement primaire (Estimé)
30 septembre 2032
Achèvement de l'étude (Estimé)
30 septembre 2032
Dates d'inscription aux études
Première soumission
22 avril 2026
Première soumission répondant aux critères de contrôle qualité
30 avril 2026
Première publication (Réel)
4 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
7 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
6 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- restor3d-011
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Oui
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .