Aequalis Pyrocarbon IDE; Replacing the Humeral Head in Hemi-Arthroplasty

A subject is a success at 24 months if:

• Their change in Constant score is greater than or equal to 17 and
• They did not have revision surgery; and
• There is no radiographic evidence of system disassembly or fracture, and
• They did not have a system-related serious adverse event.

Constant Score: In this score, 35 points are allocated for subjective assessments of pain and activities of daily living and 65 points are available for objective measures of range of movement and shoulder strength. A young healthy patient can therefore have a maximum score of 100 points. The minimum score is 0 points. The range of the score is 0-100 for both the Constant Score and the adjusted Constant score. A higher value represents a better outcome.

Average of 2 pain scores (15 points max) Sum of 4 activities of daily living questions (20 points max) Sum of 4 ROM measure (40 points max) Power score (25 points max)

Change in Constant Score and Adjusted Constant Score at 24 months compared to baseline is presented along with absolute values.

American Shoulder and Elbow Surgeons Standardized Shoulder Assessment. The original ASES consists of 2 portions, a medical professional assessment section and a patient self-report section. The patient self-report section utilized in this study is a condition specific scale intended to measure functional limitations and pain of the shoulder. The assessment takes approximately 5 minutes to complete and consists of 2 dimensions: pain and activities of daily living. The pain score is calculated from the single pain question and the function score from the sum of the 10 questions addressing function. The pain score and function composite score are weighted equally (50 points each) and combined for a total score out of a possible 100 points. The minimum score is 0 and the maximum score is 100. A higher value represents a better outcome.

Change in American Shoulder and Elbow Surgeons (ASES) Score at 24 months compared to baseline are presented.

The SANE rating is determined by the subject's written response to the following question "How would you rate your shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?"

Change in Single Assessment Numeric Evaluation (SANE) at 24 months compared to baseline

EQ-5D: a standardized instrument for use as a measure of health outcome. It is cognitively simple, takes only a few minutes to complete, and provides a simple descriptive profile as well as a single index value for health status. Scale 0 to 1; 1 (representing full health) to 0 (representing dead).

Change in EQ-5D score at 24 months compared to baseline

Pain is measured by a visual analog scale (from 0-10). The subject responds to the question: How bad is your pain TODAY. 0 is no pain; 10 is pain as bad as it can be.

Change in pain measured by a visual analog scale (VAS) at 24 months compared to baseline

Range of Motion (ROM) is a movement test conducted on a joint to diagnose level of pain and function. The shoulder joint has a greater Range of Motion than all other joints in the body. In this study, ROM was measured using a goniometer for forward flexion in relation to the thorax, abduction, and external rotation (arm at side and arm abducted to 90°).

Change in Range of Motion (ROM) at 24 months compared to baseline.

• Forward Flexion
• Abduction
• External Rotation

The subject's strength will be assessed using a fixed force gauge. The fixed force gauge is held in place by the examiner and the subject pulls upward with maximum effort for approximately five seconds. The test can be completed up to three times and the maximum score is used, however all three pulls will be recorded. The test is done only on the affected arm. The result of this test contributes to the Constant score calculation.

Change in Strength testing at 24 months compared to baseline

Adverse Events data will be collected and summarized at 24 months.

A revision is a procedure that adjusts or in any way modifies or removes any component of the original implant configuration, with or without replacement of a component, after the initial surgery. A revision may also include adjusting the position of the original configuration. An explant is a revision that includes permanent removal of any system component. If a subject has a revision that includes an addition of a glenoid component (revision to TSA) the Pyrocarbon humeral head must be permanently explanted.

The Revision Rate will be calculated and summarized at 24 months.

The level of satisfaction with the shoulder will be summarized at 24 months.

The follow data will be summarized at 24 Months:

glenohumeral joint space width, glenoid osteophytes, glenoid morphology, humeral component radiolucency, osteolysis, migration, subsidence, subluxation, acromial humeral distance, anatomic fracture, and additional observations