An observational study in Knee Injuries and Joint Surface Knee Lesions, sponsored by Smith & Nephew, Inc.. Enrolling by invitation at 8 sites in 6 countries. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by Smith & Nephew, Inc. · Observational
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).
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(Marketed Product - MP01 vs. SSOC) will enroll up to 170 subjects who participated in the pivotal study and were not withdrawn due to the index knee requiring a unicompartmental or total knee arthroplasty.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.
267 studies on the registry are indexed under Knee Injuries; 59 are open to participants now.
This study's planned enrollment of 170 is above the median of 82 across 79 observational studies indexed under Knee Injuries.
Browse Knee Injuries studies →Smith & Nephew, Inc. is the lead sponsor of 134 studies on the registry; 11 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects who had joint surface lesions of the knee randomized to be treated with Marketed Product - MP01 in the Pivotal study.
Device: Marketed Product - MP01
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.
Procedure: Surgical Standard of Care
Marketed Product - MP01 was implanted via a mini-arthrotomy or arthrotomy approach, using the designated surgical tools and surgical technique.
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.
Change from Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 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).
Time frame: Baseline and 7 years
Safety of Marketed Product - MP01 vs SSOC: Time to Event of Secondary Invasive Interventions (excluding intra-articular injections)
Kaplan-Meier survival estimates will be used to estimate time to secondary invasive intervention (open procedure, mini open procedure, arthroscopic procedure, including implant removal and conversion to knee arthroplasty) 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)
Kaplan-Meier survival estimates will be used to estimate time to secondary invasive intervention (open procedure, mini-open procedure, arthroscopic procedure, including implant removal and conversion to knee arthroplasty) including intra-articular injections.
Time frame: up to 10 years
Safety of Marketed Product - MP01 vs SSOC: Cumulative Incidence Rate
Cumulative incidence rate up to 10 years of secondary invasive interventions (open procedure, mini-open procedure, arthroscopic procedure, including implant removal and conversion to knee arthroplasty) including intra-articular injections.
Time frame: up to 10 years
Change from Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 7 Years
KOOS evaluates both short and long-term consequences of knee injury and contains 42 items including 5 subscales (pain, other symptoms, QOL, ADL, and sports). Subscale scores are converted to a 0-100 scale to determine the Overall score, 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).
Time frame: Baseline and 7 years
Change from Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 10 Years
KOOS evaluates both short and long-term consequences of knee injury and contains 42 items including 5 subscales (pain, other symptoms, QOL, ADL, and sports). Subscale scores are converted to a 0-100 scale to determine the Overall score, 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).
Time frame: Baseline and 10 years
Change from Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscales at 7 Years
KOOS evaluates both short and long-term consequences of knee injury and contains 42 items including 5 subscales (pain, other symptoms, QOL, ADL, and sports). Each item has five possible answer options scored from 0 (no problems) to 4 (extreme problems), and each of the five subscales is calculated as the sum of the associated items. Scores are converted to a 0-100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., best outcome).
Time frame: Baseline and 7 years
Change from Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscales at 10 Years
KOOS evaluates both short and long-term consequences of knee injury and contains 42 items including 5 subscales (pain, other symptoms, QOL, ADL, and sports). Each item has five possible answer options scored from 0 (no problems) to 4 (extreme problems), and each of the five subscales is calculated as the sum of the associated items. Scores are converted to a 0-100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., best outcome).
Time frame: Baseline and 10 years
Change from Baseline in Tegner Activity Scale Score at 7 Years
The Tegner Activity Scale assesses the level of work and sports-based activity prior to injury and level of activity post injury that can be documented on a numerical scale. It is a one- item questionnaire that is scored on an 11-item scale (0 to 10) based on the patient's reported level of activity/work. A level of 0 indicates the worst outcome while a level of 10 represents the best outcome.
Time frame: Baseline and 7 years
Change from Baseline in Tegner Activity Scale Score at 10 Years
The Tegner Activity Scale assesses the level of work and sports-based activity prior to injury and level of activity post injury that can be documented on a numerical scale. It is a one- item questionnaire that is scored on an 11-item scale (0 to 10) based on the patient's reported level of activity/work. A level of 0 indicates the worst outcome while a level of 10 represents the best outcome.
Time frame: Baseline and 10 years
Change from Baseline in Total 2000 International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score at 7 Years
The IKDC Subjective Knee Evaluation Form assesses the subject's opinion of their knee across 3 domains: symptoms (7 items), sports activity (2 items), and knee function (2 items; note: 'function prior to knee injury' is not included in the overall score). Responses vary for each item. The sum of all items is converted to a scale of 0 to 100, where 100 represents no limitation with activities \& absence of symptoms (i.e., the best outcome) and 0 represents the worst outcome.
Time frame: Baseline and 7 years
Change from Baseline in Total 2000 International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score at 10 Years
The IKDC Subjective Knee Evaluation Form assesses the subject's opinion of their knee across 3 domains: symptoms (7 items), sports activity (2 items), and knee function (2 items; note: 'function prior to knee injury' is not included in the overall score). Responses vary for each item. The sum of all items is converted to a scale of 0 to 100, where 100 represents no limitation with activities \& absence of symptoms (i.e., the best outcome) and 0 represents the worst outcome.
Time frame: Baseline and 10 years
Plan to share: No
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