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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Marketed Product - MP01, Surgical Standard of Care.
- Who it may be relevant to
- Registry conditions: Knee Injuries, Joint Surface Knee Lesions. Basic parameters: 21 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Belgium, Israel, Italy, Romania +1
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Detailed description
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(Marketed Product - MP01 vs. SSOC) will enroll up to 170 subjects who participated in the pivotal study and were not withdrawn due to the index knee requiring a unicompartmental or total knee arthroplasty.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.
Interventions
- Device Marketed Product - MP01
Marketed Product - MP01 was implanted via a mini-arthrotomy or arthrotomy approach, using the designated surgical tools and surgical technique. - Procedure 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 defect
Primary outcome measures
- Change from Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 7 Years [Time frame: Baseline and 7 years]
Secondary outcome measures (11)
- Safety of Marketed Product - MP01 vs SSOC: Time to Event of Secondary Invasive Interventions (excluding intra-articular injections) [Time frame: up to 10 years]
- Safety of Marketed Product - MP01 vs SSOC: Time to Event of Secondary Invasive Interventions (including intra-articular injections) [Time frame: up to 10 years]
- Safety of Marketed Product - MP01 vs SSOC: Cumulative Incidence Rate [Time frame: up to 10 years]
- Change from Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 7 Years [Time frame: Baseline and 7 years]
- Change from Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 10 Years [Time frame: Baseline and 10 years]
- Change from Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscales at 7 Years [Time frame: Baseline and 7 years]
- Change from Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscales at 10 Years [Time frame: Baseline and 10 years]
- Change from Baseline in Tegner Activity Scale Score at 7 Years [Time frame: Baseline and 7 years]
- Change from Baseline in Tegner Activity Scale Score at 10 Years [Time frame: Baseline and 10 years]
- Change from Baseline in Total 2000 International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score at 7 Years [Time frame: Baseline and 7 years]
- Change from Baseline in Total 2000 International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score at 10 Years [Time frame: Baseline and 10 years]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 2 centers
- Humanitas Gavazzeni — Bergamo
- Istituto Clinico Humanitas — Milan
Serbia · 2 centers
- Institut za Ortopedsko hiruske Bolesti "Banjica" — Belgrade
- Klinika Orto MD — Novi Sad
United States · 1 center
- Horizon Clinical Research — La Mesa
Belgium · 1 center
- AZ Monica — Antwerp
Israel · 1 center
- Hadassah Medical Center — Jerusalem
Romania · 1 center
- County Hospital Timis Othopedy and Trauma Clinic II — Timișoara
Identifiers
NCT: NCT06916728 · CLN-0029-1272