ASHCOM Shoulder System and Its Related Instruments

Terminated

Conditions: Shoulder Pain
Arthropathy; Traumatic
Rotator Cuff Injuries
Arthroplasty Complications

Interventions: Device: ASHCOM Shoulder System

Registration Number: NCT04258605

Lead Sponsor: Zimmer Biomet

Brief Summary: The objectives of this study are to confirm safety, performance and clinical benefits of the ASHCOM Shoulder System and its related instruments by analysis of standard scoring systems, radiographs and adverse event records.

Detailed Description: This study is a multicenter, prospective, non-controlled Post-Market Clinical Follow-up study involving orthopaedic surgeons skilled in reverse shoulder arthroplasty procedures. A minimum of three study centers will be involved. A total number of 97 implants will be included into the study.

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. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events.

The secondary endpoint 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. Assessments of the overall pain, functional performance, survival, quality of life and radiographic parameters of all enrolled study subjects will be evaluated in addition.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 24

Inclusion Criteria

Patient is capable of understanding the doctor's explanations, following his instructions and is able to participate in the follow-up program.
Patient has given written consent to take part in the study by signing the "Patient Consent Form".
Patient is 18-80 years of age, inclusive.
Patient is skeletally mature.
Patient requires a primary, fracture or revision reverse total shoulder replacement for the relief of pain and has significant disability due to gross rotator cuff deficiency.
Patient's joint is anatomically and structurally suited to receive the selected implants.
Patient has a functional deltoid muscle.

Exclusion Criteria

Patient is unwilling or unable to give consent or to comply with the follow-up program.
Patients who have any condition which would in the judgement of the Investigator place the patient at undue risk or interfere with the study. Any patient who is institutionalized, or is a known drug abuser, a known alcoholic or anyone who cannot understand what is required of them.
Patient is known to be pregnant or breastfeeding.
Patient is a vulnerable subject.
Patient meets at least one of the contraindications:
- Signs of infection
- Significant injury to the upper brachial plexus
- Non-functional deltoid muscle
- Insufficient quality and/or quantity of glenoid or humeral bone
- Any neuromuscular or vascular disease compromising the affected limb that would endanger the success of the intervention

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ASHCOM Shoulder System subjects	ASHCOM Shoulder System	Subjects implanted with the ASHCOM Shoulder System

Primary Outcome Measures

Name	Time	Method
Survival of Implant System (Kaplan Meier)	3 years	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.

Secondary Outcome Measures

Name	Time	Method
The Performance and Clinical Benefits of the ASHCOM Shoulder System - Constant Murley Shoulder Score (CM)	Pre-operative (baseline), 1 year, 2 years post-operative	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).
Oxford Shoulder Score (OSS)	Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative	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.
EQ-5D-5L Score	Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative	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.
Subjective Shoulder Value (SSV)	Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative	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.
Radiographic Parameters	2 years post-operative	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