ASHCOM Shoulder System and Its Related Instruments

  • STATUS
    Recruiting
  • End date
    Dec 30, 2032
  • participants needed
    97
  • sponsor
    Zimmer Biomet
Updated on 30 April 2021

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.

Details
Condition Arthralgia, TENDON INJURY, Shoulder Pain, Chronic Leg Pain, Arthroplasty Complications, Rotator Cuff Injuries, Rotator Cuff Injury, Tendon Injuries, Arthropathy; Traumatic, Arthropathy; Traumatic, Arthropathy; Traumatic, Arthropathy; Traumatic
Treatment ASHCOM Shoulder System
Clinical Study IdentifierNCT04258605
SponsorZimmer Biomet
Last Modified on30 April 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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