此页面是自动翻译的，不保证翻译的准确性。请参阅英文版对于源文本。

The restor3d Outcomes Registry

2026年7月6日更新者：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.

研究概览

地位

尚未招聘

条件

干预/治疗

设备：Patient-Specific Orthopedic Implant

研究类型

观察性的

注册 (估计的)

2000

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

成人
年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

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.

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列	干预/治疗
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.	设备：Patient-Specific Orthopedic Implant 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.	设备：Patient-Specific Orthopedic Implant 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.	设备：Patient-Specific Orthopedic Implant 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.	设备：Patient-Specific Orthopedic Implant 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.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Patient-Reported Implant Survivorship (all cohorts) 大体时间：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)

次要结果测量

结果测量	措施说明	大体时间
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 6a Score (all cohorts) 大体时间：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) 大体时间：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) 大体时间：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) 大体时间：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) 大体时间：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) 大体时间：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) 大体时间：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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Restor3D

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月30日

初级完成 (估计的)

2032年9月30日

研究完成 (估计的)

2032年9月30日

研究注册日期

首次提交

2026年4月22日

首先提交符合 QC 标准的

2026年4月30日

首次发布 (实际的)

2026年5月4日

研究记录更新

最后更新发布 (实际的)

2026年7月7日

上次提交的符合 QC 标准的更新

2026年7月6日

最后验证

2026年7月1日

The restor3d Outcomes Registry