ASHCOM Shoulder System and Its Related Instruments

Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04258605
• Other study ID #: CME2017-67E
• Status: Active, not recruiting
• Start date: December 10, 2019
• Est. completion date: December 2032

Study information

• Verified date: March 2024
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: December 2032
• Est. primary completion date: December 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• ASHCOM Shoulder System
Reverse Shoulder Arthroplasty

Locations

Country	Name	City	State
Italy	Clinica del Mediterraneo	Ragusa

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prosthesis survival	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.	10 years
Secondary	The performance and clinical benefits of the ASHCOM Shoulder System at 5 years	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.; 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.	5 years