The restor3d Outcomes Registry: Tracking Patient Recovery After Joint Replacement
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,250
- 主要终点
- Patient-Reported Implant Survivorship (all cohorts)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Master Protocol Inclusion Criteria:
- •Age ≥ 18 years
- •Prescribed an FDA-cleared or approved orthopedic implant manufactured by restor3d, Inc.
- •Master Protocol
排除标准
- •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 (to ensure accurate comprehension and completion of the surveys)
- •Patient is receiving a restor3d implant outside of the defined implant cohorts
- •Patient does not provide informed consent
研究组 & 干预措施
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.
干预措施: Patient-Specific Orthopedic Implant (Device)
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.
干预措施: Patient-Specific Orthopedic Implant (Device)
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.
干预措施: Patient-Specific Orthopedic Implant (Device)
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.
干预措施: Patient-Specific Orthopedic Implant (Device)
结局指标
主要结局
Patient-Reported Implant Survivorship (all cohorts)
时间窗: 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.
次要结局
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 6a Score (all cohorts)(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)(6 weeks post-operatively)
- Change in Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, Jr) Score (Knee cohort)(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)(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)(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)(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)(Pre-operative baseline through 5 years post-operatively (assessed at 6 weeks, 3 months, 6 months, 1, 2, 3, 4, and 5 years))