The restor3d Outcomes Registry
30. dubna 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Intervence / Léčba
Typ studie
Pozorovací
Zápis (Odhadovaný)
2000
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
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.
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Patient-Reported Implant Survivorship (all cohorts)
Časové okno: 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)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 6a Score (all cohorts)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
31. května 2026
Primární dokončení (Odhadovaný)
31. května 2032
Dokončení studie (Odhadovaný)
31. května 2032
Termíny zápisu do studia
První předloženo
22. dubna 2026
První předloženo, které splnilo kritéria kontroly kvality
30. dubna 2026
První zveřejněno (Aktuální)
4. května 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
4. května 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
30. dubna 2026
Naposledy ověřeno
1. dubna 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- restor3d-011
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ano
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