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

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