Journey™ UNI Post Market Clinical Follow-Up

The 2011 Knee Society Score consists of 4 separate sub-scales. The "Objective" Knee Score is seven items with a range of 0 to 111, with a higher score indicating a better outcome.

The 2011 Knee Society Score consists of 4 separate sub-scales. The Patient Expectation Score was three items with a range of 3 to 15 where higher scores indicated a better outcome. The Expectation score indicated the patient's opinion on the extent they expect the operation to improve their knee pain, and ability to perform activities of daily living and recreational activities.

The 2011 Knee Society Score consists of 4 separate sub-scales. The Patient Satisfaction Score is five items with a range of 0 to 40, with a higher score indicating a better outcome.

The 2011 Knee Society Score consists of 4 separate sub-scales. The Functional Score is nineteen items with a range of 0 to 100, with a higher score indicating a better outcome. Functional Score is derived from assessments of walking and standing, standard activities, advanced activities, and discretionary activities.

The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale (VAS). The Quality of Life index (i.e., index score) is used to describe the participant's health state and consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels to choose the most appropriate answer: no problems, slight problems, moderate problems, severe problems and extreme problems. The participant is asked to indicate their health state by marking the most appropriate statement in each of the five areas. The EQ-5D-5L Index Score was based on a US country code scale of -0.573 to 1, with higher index values indicating better health and lower index values indicating worse health.

The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale (VAS). The VAS records the participant's self-rated health on a vertical visual analogue scale. The scale ranges from 0 to 100 where 0 indicates 'The worst health you can imagine' and 100 indicates 'The best health you can imagine'.

Self-Administered Patient Satisfaction Survey indicated the participants satisfaction with outcomes of joint replacement surgery across four domains of pain relief, home/yard work, recreational activities, and overall satisfaction by a response to a single question for each domain. Participants were categorized based on the question "How satisfied are you with the results of your surgery?" for the associated knee using one of the following responses:

1. Very satisfied
2. Somewhat satisfied
3. Somewhat dissatisfied
4. Very dissatisfied

Self-Administered Patient Satisfaction Survey indicated the participants satisfaction with outcomes of joint replacement surgery across four domains of pain relief, home/yard work, recreational activities, and overall satisfaction by a response to a single question for each domain. Participants were categorized based on the question "How satisfied are you with the results of your surgery for improving your pain?" for the associated knee using one of the following responses:

1. Very satisfied
2. Somewhat satisfied
3. Somewhat dissatisfied
4. Very dissatisfied

Self-Administered Patient Satisfaction Survey indicated the participants satisfaction with outcomes of joint replacement surgery across four domains of pain relief, home/yard work, recreational activities, and overall satisfaction by a response to a single question for each domain. Participants were categorized based on the question "How satisfied are you with the results of surgery for improving your ability to do home or yard work?" for the associated knee using one of the following responses:

1. Very satisfied
2. Somewhat satisfied
3. Somewhat dissatisfied
4. Very dissatisfied

Self-Administered Patient Satisfaction Survey indicated the participants satisfaction with outcomes of joint replacement surgery across four domains of pain relief, home/yard work, recreational activities, and overall satisfaction by a response to a single question for each domain. Participants were categorized based on the question "How satisfied are you with the results of surgery for improving your ability to do recreational activities?" for the associated knee using one of the following responses:

1. Very satisfied
2. Somewhat satisfied
3. Somewhat dissatisfied
4. Very dissatisfied

The Forgotten Joint Score (FJS) comprises measures for the assessment of joint-specific patient reported outcomes. Participants are asked to rate their awareness of their knee arthroplasty in 12 questions with a five point Likert response format: "Never", "almost never", "seldom", "sometimes" and "mostly". The item scores are summed and linearly transformed in a 0 to 100 scale with a high value reflecting the ability of the subject to forget about the replaced knee joint during the activities of daily living (i.e., a higher score is a better outcome).

Perform weight-bearing antero-posterior (A/P) and lateral standard x-rays to determine the mechanical alignment in degrees.

Performed weight-bearing antero-posterior (A/P) and lateral standard x-rays to determine loosening of the implant (Yes/No).

Performed weight-bearing antero-posterior (A/P) and lateral standard x-rays to determine subsidence/migration of the implant (Yes/No).

Performed weight-bearing antero-posterior (A/P) and lateral standard x-rays to determine presence of stress shielding (Yes/No).

Performed weight-bearing antero-posterior (A/P) and lateral standard x-rays to determine periprosthetic fracture (Yes/No).

Performed weight-bearing antero-posterior (A/P) and lateral standard x-rays to determine wear of the articulating surfaces of replacement components (Yes/No).

Performed weight-bearing antero-posterior (A/P) and lateral standard x-rays to determine if presence of radioloucencies were all negative (Yes/No). A 'Yes' response indicated no presence of radiolucent lines.

Performed weight-bearing antero-posterior (A/P) and lateral standard x-rays to determine if presence of femoral zone radioloucencies were all negative (Yes/No). A 'Yes' response indicated no presence of radiolucent lines in the femoral zone of the knee.

Performed weight-bearing antero-posterior (A/P) and lateral standard x-rays to determine if presence of anterior medial-lateral (ML) zone radioloucencies were all negative (Yes/No). A 'Yes' response indicated no presence of radiolucent lines in the anterior medial-lateral zone of the knee.

Performed weight-bearing antero-posterior (A/P) and lateral standard x-rays to determine if presence of lateral medial-lateral (ML) zone radioloucencies were all negative (Yes/No). A 'Yes' response indicated no presence of radiolucent lines in the lateral medial-lateral zone of the knee.