G7 Freedom Constrained Vivacit-E Liners

Safety is assessed by monitoring the frequency and incidence of all adverse events, with particular focus on those that may be related to the study device.

The Harris Hip Score evaluates hip function, pain, mobility and daily activity impairment after hip replacement surgery.

The ten items in the Harris hip score consist of answer choices, awarded a number of points. There are four domains evaluated, as follows:

• Pain - 1 item which scores between 0 and 44;
• Function - 7 items, scores are between 0 and 47;
• Deformity - 1 item which scores either 0 or 4;
• Range of motion - 1 item which scores between 0 and 5.

The overall score varies between 0 and 100, where scores closer to 0 are suggestive of impaired hip function and scores closer to 100 indicate positive outcome.

There are four categories of hip function status:

• <70: poor hip status;
• 70 - 79: fair hip status;
• 80 - 89: good hip status;
• 90 - 100: excellent hip status.

"The Oxford Hip Score is patient-reported outcome instrument which contains 12 questions on activities of daily living that assess function and residual pain in patients undergoing total hip replacement surgery.

Grading the Oxford Hip Score 0 to 19-May indicate severe hip arthritis... 20 to 29-May indicate moderate to severe hip arthritis... 30 to 39-May indicate mild to moderate hip arthritis... 40 to 48-May indicate satisfactory joint function..." Oxford Hip Score. (n.d.) Segen's Medical Dictionary. (2011). Retrieved August 19 2022 from https://medical-dictionary.thefreedictionary.com/Oxford+Hip+Score

Each question is scored from 0 to 4 with 4 being the best outcome. This method, when summed, produces overall scores running from 0 to 48 with 48 being the best outcome. The overall score is reached by simply summing the scores received for individual questions. This results in a continuous score ranging from 0 (most severe symptoms) to 48 (least symptoms).

The EuroQol five dimensions questionnaire (EQ-5D-5L) is a five dimensional self-assessment that is comprised of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. These five dimensions can be used to index a subject's health utility on a scale of 0 to 1, where 0 is death and 1 is perfect health. The scoring rule for EQ-5D permits scores less than 0, implying that some health states may be worse than death. Note: no VAS measures will be obtained if completed by phone interview.

X-rays will be evaluated for radiolucency lines to show the number of subjects with radiolucency. Radiolucency refers to structures that are less dense and permit the x-ray beam to pass through them. Radiolucent structures appear dark or black in the radiographic image.

X-rays will be evaluated for osteolysis to show the number of subjects with osteolysis. Osteolysis is a progressive condition where bone tissue is destroyed. In this process, bones lose minerals (mostly calcium), softens, degenerates and become weaker.

X-rays will be evaluated for muscular atrophy/hypertrophy. An increase in total mass of a muscle is referred to as as hypertrophy, whereas a decrease in total mass of a muscle is referred to as atrophy.

X-rays will be evaluated for component migration to show the number of subjects with migration. Component migration refers to the presence of the device component gradually moving anteriorly, posteriorly, superiorly, or inferiorly in relation to original placement.

Radiographs will be evaluated (up to 5 years) for evidence of device fracture.

X-rays will be evaluated for heterotopic ossification to show the number of subjects with heterotopic ossification. Heterotopic ossification refers to the presence of bone in soft tissue where bone normally does not exist (extraskeletal bone).