Clinical trial NCT06916728: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Knee Injuries
Joint Surface Knee Lesions
Keywords: Knee cartilage lesions
joint surface lesions of the knee
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Cartiheal (2009) Ltd
First posted: 2025-04-08
Enrollment: 170
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Up to 170 subjects who had joint surface lesions of the knee, participated in the pivotal study and consent to continue follow-up will be enrolled.

Brief 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).

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(Marketed Product - MP01 vs. SSOC) will enroll up to 170 subjects who participated in the pivotal study and were not withdrawn due to the index knee requiring a unicompartmental or total knee arthroplasty.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.

Eligibility criteria: 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 outcomes:
measure: Change from Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 7 Years
timeFrame: Baseline and 7 years
Secondary outcomes:
measure: Safety of Marketed Product - MP01 vs SSOC: Time to Event of Secondary Invasive Interventions (excluding intra-articular injections)
timeFrame: up to 10 years
measure: Safety of Marketed Product - MP01 vs SSOC: Time to Event of Secondary Invasive Interventions (including intra-articular injections)
timeFrame: up to 10 years
measure: Safety of Marketed Product - MP01 vs SSOC: Cumulative Incidence Rate
timeFrame: up to 10 years
measure: Change from Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 7 Years
timeFrame: Baseline and 7 years
measure: Change from Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 10 Years
timeFrame: Baseline and 10 years
measure: Change from Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscales at 7 Years
timeFrame: Baseline and 7 years
measure: Change from Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscales at 10 Years
timeFrame: Baseline and 10 years
measure: Change from Baseline in Tegner Activity Scale Score at 7 Years
timeFrame: Baseline and 7 years
measure: Change from Baseline in Tegner Activity Scale Score at 10 Years
timeFrame: Baseline and 10 years
measure: Change from Baseline in Total 2000 International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score at 7 Years
timeFrame: Baseline and 7 years
measure: Change from Baseline in Total 2000 International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score at 10 Years
timeFrame: Baseline and 10 years
Other outcomes:
Locations:
city: La Mesa
country: United States
facility: Horizon Clinical Research
state: California
city: Antwerp
country: Belgium
facility: AZ Monica
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Bergamo
country: Italy
facility: Humanitas Gavazzeni
city: Milan
country: Italy
facility: Istituto Clinico Humanitas
city: Kraków
country: Poland
facility: Szpitalem Specjalistycznym im. Ludwika Rydygiera w Krakowie sp. z o.o.
city: Timișoara
country: Romania
facility: County Hospital Timis Othopedy and Trauma Clinic II
city: Belgrade
country: Serbia
facility: Institut za Ortopedsko hiruske Bolesti "Banjica"
city: Belgrade
country: Serbia
facility: Sava Memorial Hospital
city: Novi Sad
country: Serbia
facility: Klinika Orto MD
Study officials:
affiliation: Smith & Nephew, Inc.
name: Samantha Andrews
role: STUDY_CHAIR
References: