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
Marketed Product - MP01: Marketed Product - MP01 was implanted via a mini-arthrotomy or arthrotomy approach, using the designated surgical tools and surgical technique.
Surgical Standard of Care: As no single, current therapy could be used as a single comparator for the treatment of the knee lesions treated in the pivotal study which included focal cartilage lesions on the one hand and moderate knee osteoarthritis on the other, current general practice (e.g., SSOC: Deb and MFx) was used.
Deb (SSOC) is a common orthopedic surgical procedure that removes damaged cartilage and tissue from the knee. MFx (SSOC) is another common orthopedic surgical procedure that treats knee cartilage defects by creating small holes in the bone beneath the damaged cartilage.
Study summary
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).
Eligibility
Sex
ALL
Min age
21 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Participated in the pivotal study.
2. Must be physically and mentally willing and able to comply with the follow-up schedule.
3. Signed and dated the IEC/IRB approved Informed Consent Form and HIPPA (if applicable).
Exclusion Criteria:
1. Withdrawn from the pivotal study due to index knee requiring a unicompartmental or total knee arthroplasty.
2. Chemotherapy in the past 12 months.
3. Participation in other clinical trials involving knee procedures.
4. 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).
Primary outcome measure(s)
Change from Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 7 Years — 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).
Trial sites (8)
Facility
City
Region
Status
Horizon Clinical Research
La Mesa
California
AZ Monica
Antwerp
Belgium
Hadassah Medical Center
Jerusalem
Israel
Humanitas Gavazzeni
Bergamo
Italy
Istituto Clinico Humanitas
Milan
Italy
County Hospital Timis Othopedy and Trauma Clinic II
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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