- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Ragusa, Italy, 97100
- Clinica del Mediterraneo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
ASHCOM Shoulder System subjects
Subjects implanted with the ASHCOM Shoulder System
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Reverse Shoulder Arthroplasty
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prosthesis survival
Time Frame: 10 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.
|
10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The performance and clinical benefits of the ASHCOM Shoulder System at 5 years
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marcello Stamilla, MD, Clinica del Mediterraneo
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CME2017-67E
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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