ASHCOM Shoulder System and Its Related Instruments

NCT ID: NCT04258605

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-12-10
• Study Completion Date: 2024-08-13

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ASHCOM Shoulder System subjects

Subjects implanted with the ASHCOM Shoulder System

ASHCOM Shoulder System

Intervention Type: DEVICE

Reverse Shoulder Arthroplasty

Interventions

ASHCOM Shoulder System

Reverse Shoulder Arthroplasty

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marcello Stamilla, MD

Role: PRINCIPAL_INVESTIGATOR

Clinica del Mediterraneo

Locations

Clinica del Mediterraneo

Ragusa, , Italy

Countries

Italy

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CME2017-67E

Identifier Type: -

Identifier Source: org_study_id