ASHCOM Shoulder System and Its Related Instruments

The primary endpoint is defined by the survival of the implant at 10 years which is based on removal or intended removal of the prosthesis and will be determined using Kaplan Meier method. Due to early study termination, the survival of the implant was analyzed at 3 years.

Time frame: 3 years

The EQ-5D-5L is a standardized instrument widely used to measure health status. It is a self-reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The questionnaire includes 5 questions referring to mobility, self-care, daily activities, pain/discomfort and anxiety/depression. Each question can be answered in five ways, indicating no, slight, moderate, severe problems or inability to complete the task. In the derived EQ-5D-5L score, the highest score is 1 and the lowest score is -0.573. It included the Health State, which is a self-reported assessment about the patient's health on that day at a VAS from 0 to 100 with 100 being the best health one can imagine and 0 the worst.

Time frame: Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative

Population: The number analyzed in one or more rows differs from overall number analyzed, as one patient passed away prior to the 3-6 month visit and for one patient the score was not collected at the 3-6 months and 1 year follow-up visit.

The Oxford Shoulder Score (OSS) is a patient-reported outcome questionnaire that was developed to specifically assess the patient's perspective of outcome following total shoulder arthroplasty. The OSS consists of twelve questions covering function and pain associated with the shoulder. To calculate the total score, each question is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible and a minimum of 0, representing the worst possible. The outcome score can be categorized as: Satisfactory Joint Function: 40 - 48, Moderate-Mild Arthritis: 30 - 39, Moderate-Severe Arthritis: 20 - 29, Severe Arthritis: 0 - 19.

Time frame: Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative

Population: The number analyzed in one or more rows differs from overall number analyzed, as one patient passed away prior to the 3-6 month visit and for one patient the score was not collected at the 2 years follow-up.

Radiographic parameters: X-rays have been evaluated for radiolucency, osteolysis, atrophy, hypertrophy, osteophytes (glenoid), component migration (humeral stem subsidence / glenoid component migration), heterotopic ossification and scapular notching

Time frame: 2 years post-operative

Population: ASHCOM Shoulder System subjects - Uncemented humeral stem: The number analyzed at 2 years is 21, as one patient passed away prior to the 3-6 month visit.

The Subjective Shoulder Value (SSV) is a single point, subjective estimate of a patient's condition. The patient is asked to rate the functionality of their operated shoulder on a scale of 0% - 100% of normal.

Time frame: Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative

Population: The number analyzed in one or more rows differs from overall number analyzed, as one patient passed away prior to the 3-6 month visit. For one patient the score was not collected at the 3-6 months follow-up visit and for two patients at the 1 year follow-up visit.

The secondary endpoint of this study is defined by the performance and clinical benefits of the ASHCOM Shoulder System at 5 years, which is assessed by the Constant and Murley score. Due to early study termination, the Constant and Murley Score was assessed at 2 years. The Constant and Murley score is a 100-point functional shoulder assessment tool in which higher scores reflect increased function. The subjective variables are pain (15 points) and function (activities of daily living - sleep, work, recreation/sport; 20 points), for a total of 35 points. The objective variables are active range of motion (clinician assessment; 40 points) and strength (25 points), for a total of 65 points. The minimum score is 0 points (worst outcome), the maximum score possible is 100 points (best outcome).

Time frame: Pre-operative (baseline), 1 year, 2 years post-operative

Population: The number analyzed in one or more rows differs from overall number analyzed, as one patient passed away prior to the 3-6 month visit and for one patient the score was not collected at the 2 years follow-up.