ASHCOM Shoulder System and Its Related Instruments (NCT04258605) | Clinical Trial Compass
TerminatedNot Applicable
ASHCOM Shoulder System and Its Related Instruments
Stopped: Termination of PMCF study due to product discontinuation.
Italy24 participantsStarted 2019-12-10
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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