A Post Approval Multicenter 10 Year Follow-up Observational Trial of Marketed Product - MP01 vs. Surgical Standard of Care (SSOC) Used for the Treatment of Joint Surface Lesions of the Knee
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 170
- 试验地点
- 17
- 主要终点
- Change from Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 7 Years
研究概览
简要总结
The purpose of the study is to support market adoption and global market access via collection of long-term effectiveness, safety, and radiographic data. The primary hypothesis is that Marketed Product (MP01) retains its superiority over Surgical Standard of Care (SSOC) at 7 years in term of mean improvement in the overall Knee Injury and Osteoarthritis Outcome Score (KOOS).
详细描述
This is a post approval, multicenter, prospective, comparative, non blinded 10-year follow-up observational study of Marketed Product - MP01 vs SSOC used for the treatment of joint surface lesions of the knee. Up to 12 sites in the United States (US) and outside of the US (OUS) that participated in the pivotal study "A Prospective Multicenter Open-label Randomized Controlled Trial of Marketed Product - MP01 vs. Surgical Standard of Care (SSOC) for the Treatment of Joint Surface Lesions of the Knee" (Marketed Product - MP01 vs. SSOC) will enroll up to 170 subjects who participated in the pivotal study and were not withdrawn due to the index knee requiring a unicompartmental or total knee arthroplasty. Enrolled subjects will be followed up to an additional 5 years post pivotal study procedure. As randomization was 2:1 in the pivotal study, the expected number of Marketed Product - MP01 and SSOC subjects enrolled into this study are approximately 114 and 56, respectively.
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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participated in the pivotal study.
- •Must be physically and mentally willing and able to comply with the follow-up schedule.
- •Signed and dated the IEC/IRB approved Informed Consent Form and HIPPA (if applicable).
排除标准
- •Withdrawn from the pivotal study due to index knee requiring a unicompartmental or total knee arthroplasty.
- •Chemotherapy in the past 12 months.
- •Participation in other clinical trials involving knee procedures.
- •Vulnerable individual including prisoners (i.e., unable to fully understand all aspects of the study that are relevant to the decision to participate or could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response).
研究组 & 干预措施
Marketed Product - MP01
Subjects who had joint surface lesions of the knee randomized to be treated with Marketed Product - MP01 in the Pivotal study.
干预措施: Marketed Product - MP01 (Device)
Surgical Standard of Care - SSOC
Subjects who had joint surface lesions of the knee randomized to be treated with Surgical Standard of Care (SSOC) - microfracture or debridement in the Pivotal study.
干预措施: Surgical Standard of Care (Procedure)
结局指标
主要结局
Change from Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 7 Years
时间窗: Baseline and 7 years
Long-term effectiveness of Marketed Product - MP01 compared to SSOC measured by change in baseline to year 7 in overall KOOS (mean of Pain, Symptoms, Quality of Life (QOL), Function in Daily Living (ADL) and Sports subscales) in subjects treated with Marketed Product - MP01 vs SSOC. Baseline is defined as the pivotal study screening visit. Overall scores are converted to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems (i.e., a lower score is a worse outcome, and high score is a better outcome).
次要结局
- Safety of Marketed Product - MP01 vs SSOC: Time to Event of Secondary Invasive Interventions (excluding intra-articular injections)(up to 10 years)
- Safety of Marketed Product - MP01 vs SSOC: Time to Event of Secondary Invasive Interventions (including intra-articular injections)(up to 10 years)
- Safety of Marketed Product - MP01 vs SSOC: Cumulative Incidence Rate(up to 10 years)
- Change from Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 7 Years(Baseline and 7 years)
- Change from Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 10 Years(Baseline and 10 years)
- Change from Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscales at 7 Years(Baseline and 7 years)
- Change from Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscales at 10 Years(Baseline and 10 years)
- Change from Baseline in Tegner Activity Scale Score at 7 Years(Baseline and 7 years)
- Change from Baseline in Tegner Activity Scale Score at 10 Years(Baseline and 10 years)
- Change from Baseline in Total 2000 International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score at 7 Years(Baseline and 7 years)
- Change from Baseline in Total 2000 International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score at 10 Years(Baseline and 10 years)