Functional Responder Rate with an Objective Performance Criteria of 85% as measured by the KOOS questionnaire for the first 225 tibia

Data were not collected as the study terminated prior to the pre-specified analysis timepoint.

This measure will assess the percentage of knees with reported AEs throughout the duration of the study.

This measure will assess the mean number of AEs per Knee for those knees with reported AEs throughout the duration of the study.

6 subjects experienced at least 1 AE

This measure will assess count of knees with various types of device deficiencies reported throughout the duration of the study.

There were no reported device deficiencies.

This measure will assess the mean number of device deficiencies (DD) per knee reported throughout the duration of the study.

There were no occurrences of device deficiencies reported.

Functional Responder Rate with an Objective Performance Criteria of 85% as measured by the KOOS questionnaire for all subjects.

Data were not collected as the study terminated prior to the pre-specified analysis timepoint.

Number/rate of subjects with all implants remaining implanted at the 1 year timepoint.

Data were not collected as the study terminated prior to the pre-specified analysis timepoint.

Number/rate of subjects with all implants remaining implanted at the 2- year timepoint.

Data were not collected as the study terminated prior to the pre-specified analysis timepoint.

Number/rate of subjects with all implants remaining implanted at the 5- year timepoint.

Data were not collected as the study terminated prior to the pre-specified analysis timepoint.

Mixed outcome measure that derives a score using physician input and patient input including current symptoms, knee function, patient satisfaction and expectations.

This includes analysis for all subjects with scorable KSS forms. Not all visits yielded scorable forms. For all categories, higher values are considered better than lower values.

Mixed outcome measure that derives a score using physician input and patient input including current symptoms, knee function, patient satisfaction and expectations.

This includes analysis for all subjects with scorable KSS forms. Not all visits yielded scorable forms. For all categories, higher values are considered better than lower values.

Mixed outcome measure that derives a score using physician input and patient input including current symptoms, knee function, patient satisfaction and expectations. The higher the score, the better the function, satisfaction, and expectations.

Data were not collected as the study terminated prior to the pre-specified analysis timepoint. For all categories, higher values are considered better than lower values.

Mixed outcome measure that derives a score using physician input and patient input including current symptoms, knee function, patient satisfaction and expectations. The higher the score, the better the function, satisfaction, and expectations.

Data were not collected as the study terminated prior to the pre-specified analysis timepoint. For all categories, higher values are considered better than lower values.

Mixed outcome measure that derives a score using physician input and patient input including current symptoms, knee function, patient satisfaction and expectations. The higher the score, the better the function, satisfaction, and expectations.

Data were not collected as the study terminated prior to the pre-specified analysis timepoint. For all categories, higher values are considered better than lower values.

A knee-specific instrument that derives a score developed to assess the patients' opinion about their knee and associated problems. The scores for each dimension are calculated by summing the answers to the questions. The resulting scores are then transferred to a scale from 0 to 100 with 0 representing extreme knee problems and 100 representing no problems.

Analysis not completed due to early closure of the study.

A knee-specific instrument that derives a score developed to assess the patients' opinion about their knee and associated problems. The scores for each dimension are calculated by summing the answers to the questions. The resulting scores are then transferred to a scale from 0 to 100 with 0 representing extreme knee problems and 100 representing no problems.

Analysis not completed due to early closure of the study.

A knee-specific instrument that derives a score developed to assess the patients' opinion about their knee and associated problems. The scores for each dimension are calculated by summing the answers to the questions. The resulting scores are then transferred to a scale from 0 to 100 with 0 representing extreme knee problems and 100 representing no problems.

Data were not collected as the study terminated prior to the pre-specified analysis timepoint.

A knee-specific instrument that derives a score developed to assess the patients' opinion about their knee and associated problems. The scores for each dimension are calculated by summing the answers to the questions. The resulting scores are then transferred to a scale from 0 to 100 with 0 representing extreme knee problems and 100 representing no problems.

Data were not collected as the study terminated prior to the pre-specified analysis timepoint.

A knee-specific instrument that derives a score developed to assess the patients' opinion about their knee and associated problems. The scores for each dimension are calculated by summing the answers to the questions. The resulting scores are then transferred to a scale from 0 to 100 with 0 representing extreme knee problems and 100 representing no problems.

Data were not collected as the study terminated prior to the pre-specified analysis timepoint.

The Forgotten Joint Scores comprise measures for the assessment of joint-specific patient-reported outcome (PRO). These PRO questionnaires focus on patients' awareness of a specific joint in everyday life. Joint awareness can be simply defined as any unintended perception of a joint. This may include strong sensations like pain, but also includes more subtle feelings like mild stiffness, subjective dysfunction, or any discomfort. The FJS-12 score ranges from 0 to 100, with 0 being the worst score and 100 being the best. A higher score means the patient is better able to forget about the artificial joint in daily life. So, the higher the score, the better the outcome is

Analysis not completed due to early closure of the study.

The Forgotten Joint Scores comprise measures for the assessment of joint-specific patient-reported outcome (PRO). These PRO questionnaires focus on patients' awareness of a specific joint in everyday life. Joint awareness can be simply defined as any unintended perception of a joint. This may include strong sensations like pain, but also includes more subtle feelings like mild stiffness, subjective dysfunction, or any discomfort. The FJS-12 score ranges from 0 to 100, with 0 being the worst score and 100 being the best. A higher score means the patient is better able to forget about the artificial joint in daily life. So, the higher the score, the better the outcome is

Analysis not completed due to early closure of the study.

The Forgotten Joint Scores comprise measures for the assessment of joint-specific patient-reported outcome (PRO). These PRO questionnaires focus on patients' awareness of a specific joint in everyday life. Joint awareness can be simply defined as any unintended perception of a joint. This may include strong sensations like pain, but also includes more subtle feelings like mild stiffness, subjective dysfunction, or any discomfort. The FJS-12 score ranges from 0 to 100, with 0 being the worst score and 100 being the best. A higher score means the patient is better able to forget about the artificial joint in daily life. So, the higher the score, the better the outcome is

Data were not collected as the study terminated prior to the pre-specified analysis timepoint.

The Forgotten Joint Scores comprise measures for the assessment of joint-specific patient-reported outcome (PRO). These PRO questionnaires focus on patients' awareness of a specific joint in everyday life. Joint awareness can be simply defined as any unintended perception of a joint. This may include strong sensations like pain, but also includes more subtle feelings like mild stiffness, subjective dysfunction, or any discomfort. The FJS-12 score ranges from 0 to 100, with 0 being the worst score and 100 being the best. A higher score means the patient is better able to forget about the artificial joint in daily life. So, the higher the score, the better the outcome is

Data were not collected as the study terminated prior to the pre-specified analysis timepoint.

The Forgotten Joint Scores comprise measures for the assessment of joint-specific patient-reported outcome (PRO). These PRO questionnaires focus on patients' awareness of a specific joint in everyday life. Joint awareness can be simply defined as any unintended perception of a joint. This may include strong sensations like pain, but also includes more subtle feelings like mild stiffness, subjective dysfunction, or any discomfort. The FJS-12 score ranges from 0 to 100, with 0 being the worst score and 100 being the best. A higher score means the patient is better able to forget about the artificial joint in daily life. So, the higher the score, the better the outcome is

Data were not collected as the study terminated prior to the pre-specified analysis timepoint.

The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. Scores are derived by a 5 digit code. The higher the number, the better the overall health status of the patient.

Analysis not completed due to early closure of the study.

The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. Scores are derived by a 5 digit code. The higher the number, the better the overall health status of the patient.

Analysis not completed due to early closure of the study.

The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. Scores are derived by a 5 digit code. The higher the number, the better the overall health status of the patient.

Data were not collected as the study terminated prior to the pre-specified analysis timepoint.

The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. Scores are derived by a 5 digit code. The higher the number, the better the overall health status of the patient.

Data were not collected as the study terminated prior to the pre-specified analysis timepoint.

The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. Scores are derived by a 5 digit code. The higher the number, the better the overall health status of the patient.

Data were not collected as the study terminated prior to the pre-specified analysis timepoint.

Rate of radiolucencies and other significant radiographic findings identified by clinical investigators.

Rate of radiolucencies and other significant radiographic findings identified by clinical investigators.

Data were not collected as the study terminated prior to the pre-specified analysis timepoint.

Rate of radiolucencies and other significant radiographic findings identified by clinical investigators.

Data were not collected as the study terminated prior to the pre-specified analysis timepoint.

Rate of radiolucencies and other significant radiographic findings identified by clinical investigators.

Data were not collected as the study terminated prior to the pre-specified analysis timepoint.