NCT04258605

ASHCOM Shoulder System and Its Related Instruments

ASHCOM Shoulder System and Its Related Instruments - A Multicenter, Prospective, Non-Controlled Post Market Clinical Follow-up Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 24 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	ASHCOM Shoulder System	Reverse Shoulder Arthroplasty

Timeline

• Start date: 2019-12-10
• Primary completion: 2023-12-18
• Completion: 2024-08-13
• First posted: 2020-02-06
• Last updated: 2025-04-03
• Results posted: 2025-04-03

Locations

1 site across 1 country: Italy