The restor3d Outcomes Registry
30. April 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Studientyp
Beobachtungs
Einschreibung (Geschätzt)
2000
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
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.
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Patient-Reported Implant Survivorship (all cohorts)
Zeitfenster: 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)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 6a Score (all cohorts)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
31. Mai 2026
Primärer Abschluss (Geschätzt)
31. Mai 2032
Studienabschluss (Geschätzt)
31. Mai 2032
Studienanmeldedaten
Zuerst eingereicht
22. April 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
30. April 2026
Zuerst gepostet (Tatsächlich)
4. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
4. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
30. April 2026
Zuletzt verifiziert
1. April 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- restor3d-011
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Ja
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