The restor3d Outcomes Registry
6 juli 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Studietype
Observationeel
Inschrijving (Geschat)
2000
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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.
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Patient-Reported Implant Survivorship (all cohorts)
Tijdsspanne: 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)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 6a Score (all cohorts)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
30 september 2026
Primaire voltooiing (Geschat)
30 september 2032
Studie voltooiing (Geschat)
30 september 2032
Studieregistratiedata
Eerst ingediend
22 april 2026
Eerst ingediend dat voldeed aan de QC-criteria
30 april 2026
Eerst geplaatst (Werkelijk)
4 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
7 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
6 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- restor3d-011
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Ja
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .