This subscore of the overall HHS provides the patient with 6 possible answers to choose from ranging from, no pain/ignores it, to totally disabled/crippled/pain in bed/bedridden. A maximum of 44 points is possible for this subscore indicating no pain/ignores it.

Pain:

1. None or ignores it = 44 points
2. Slight, occasional, no compromise in activities = 40 points
3. Mild pain, no effect on average activities, rarely moderate pain with unusual activity, may take aspirin = 30 points
4. Moderate pain, tolerable but makes concessions to pain. Some limitation of ordinary activity or work. May require occasional pain medicine stronger than aspirin = 20 points
5. Marked pain, serious limitation of activities = 10 points
6. Totally disabled, crippled, pain in bed, bedridden = 0 points

This subscore of the overall HHS includes the total points awarded for five different ranges of motion (flexion, abduction, external rotation, internal rotation, adduction). Subscore range is minimum of 0 to maximum of 5 points; the higher the value, the better the outcome.

Flexion:

0-45 degrees x 1.0 index value = max 45 points

45-90 degrees x 0.6 index = max 27 points

90-110 degrees x 0.3 index = max 6 points

110-130 degrees = max 0 points

Abduction:

0-15 degrees x 0.8 index = max 12 points

15-20 degrees x 0.3 index = max 1.5 points

20-45 degrees x 0 index = max 0 points

External Rotation in extension:

0-15 degrees x 0.4 index = max 6 points

Over 15 degrees = max 0 points

Internal Rotation in extension:

Any = max 0 points

Adduction:

0-15 degrees x 0.2 index = max 3 points

Over 15 degrees - max 0 points

To determine the over-all rating for range of motion, multiply the sum of the index values x 0.05.

The change in SF-12 is reported by comparing the mean preoperative, 1, 3, and 5 year scores. The SF-12 Health Survey is a 12 item patient completed questionnaire to measure general health and well-being. It includes a physical component score and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.

The change in LEAS is reported by comparing the mean pre-operative, 1,3,and 5 year scores. The LEAS completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.

The number of hips that experienced a hip dislocation.

Radiographic instability is defined as having any of the following findings on x-ray:

• Radiographic indication of progressive radiolucent lines ≥ 2 mm in thickness around the entire acetabular component
• Radiographic indication of migration of ≥ 3 mm or ≥ 5° of the acetabular component
• Radiographic indication of progressive radiolucent lines ≥ 2 mm thickness around the entire femoral component
• Radiographic indication of progressive subsidence of the femoral component of ≥ 5 mm.

A revision is defined as surgical removal and replacement of the femoral bearing head or femoral stem components, or the acetabular shell or acetabular polyethylene liner.

The 97.42% estimate is obtained by Kaplan-Meier method.

The change in HHS is reported by comparing the mean preoperative, 1, 3, and 5 year scores. The HHS assesses pain, function, joint deformity and range of motion. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor.

90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor

Participants/hips with available data. Overall number of participants and hips analyzed is based upon the preoperative population.

This subscore of the overall HHS provides the patient with 6 possible answers to choose from ranging from, no pain/ignores it, to totally disabled/crippled/pain in bed/bedridden. A maximum of 44 points is possible for this subscore indicating no pain/ignores it.

Pain:

1. None or ignores it = 44 points
2. Slight, occasional, no compromise in activities = 40 points
3. Mild pain, no effect on average activities, rarely moderate pain with unusual activity, may take aspirin = 30 points
4. Moderate pain, tolerable but makes concessions to pain. Some limitation of ordinary activity or work. May require occasional pain medicine stronger than aspirin = 20 points
5. Marked pain, serious limitation of activities = 10 points
6. Totally disabled, crippled, pain in bed, bedridden = 0 points

Participants/hips with available data. Overall number of participants and hips analyzed is based upon the preoperative population.

This subscore of the overall HHS includes the total points awarded for five different ranges of motion (flexion, abduction, external rotation, internal rotation, adduction). Subscore range is minimum of 0 to maximum of 5 points; the higher the value, the better the outcome.

Flexion:

0-45 degrees x 1.0 index value = max 45 points

45-90 degrees x 0.6 index = max 27 points

90-110 degrees x 0.3 index = max 6 points

110-130 degrees = max 0 points

Abduction:

0-15 degrees x 0.8 index = max 12 points

15-20 degrees x 0.3 index = max 1.5 points

20-45 degrees x 0 index = max 0 points

External Rotation in extension:

0-15 degrees x 0.4 index = max 6 points

Over 15 degrees = max 0 points

Internal Rotation in extension:

Any = max 0 points

Adduction:

0-15 degrees x 0.2 index = max 3 points

Over 15 degrees - max 0 points

To determine the over-all rating for range of motion, multiply the sum of the index values x 0.05.

Participants/hips with available data. Overall number of participants and hips analyzed is based upon the preoperative population.

Cases at 1 and 5 years all had a score of 5, therefore there is zero standard deviation.

The change in SF-12 is reported by comparing the mean preoperative, 1, 3, and 5 year scores. The SF-12 Health Survey is a 12 item patient completed questionnaire to measure general health and well-being. It includes a physical component score and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.

Participants/hips with available data. Overall number of participants and hips analyzed is based upon the preoperative population.

The change in LEAS is reported by comparing the mean pre-operative, 1,3,and 5 year scores. The LEAS completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.

Participants/hips with available data. Overall number of participants and hips analyzed is based upon the preoperative population.

The number of hips that experienced a hip dislocation.

Participants/hips with available data. Overall number of participants and hips analyzed is based upon the 3 year population.

Radiographic instability is defined as having any of the following findings on x-ray:

• Radiographic indication of progressive radiolucent lines ≥ 2 mm in thickness around the entire acetabular component
• Radiographic indication of migration of ≥ 3 mm or ≥ 5° of the acetabular component
• Radiographic indication of progressive radiolucent lines ≥ 2 mm thickness around the entire femoral component
• Radiographic indication of progressive subsidence of the femoral component of ≥ 5 mm.

Participants/hips with available data. Overall number of participants and hips analyzed is based upon the 1 year population.

A revision is defined as surgical removal and replacement of the femoral bearing head or femoral stem components, or the acetabular shell or acetabular polyethylene liner.

The 97.42% estimate is obtained by Kaplan-Meier method.

Participants/hips with available data.

LFIT™ Femoral Heads With X3® Insert. Non-operative site events are reported by participant.

To test if the change from pre-operative SF-12 Mental component score compared to the post-operative SF-12 Mental component score at 3 years is statistically significant.

To test if the change from pre-operative SF-12 Mental component score compared to the post-operative SF-12 Mental component score at 5 years is statistically significant.