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The purpose of the study is to collect data to demonstrate the safety and effectiveness of the Easytech Reversed Shoulder System for the treatment of patients who require a reverse total shoulder arthroplasty.
Full description
The clinical study will enroll patient who require a reverse total shoulder arthroplasty as a result of osteoarthritis, post-traumatic arthritis, avascular necrosis and have a massive and non-repairable rotator cuff tear and a functional deltoid muscle.
If patients meet the eligibility criteria, evaluations and x-rays will be completed pre-operatively and post-operatively out to 24 months.
Enrollment
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Inclusion criteria
Patients are 21 years or older.
Patients are skeletally mature as evident by scapula and proximal humerus closure.
Patients exhibit clinical indications for primary reverse total shoulder arthroplasty based on physical exam and medical history including the following: osteoarthritis, post-traumatic arthritis, or avascular necrosis.
Patients have a massive and non-repairable rotator cuff tear.
Patients have a functional deltoid muscle.
Patients are anatomically and structurally suited to receive the implants;
a. Subject show sufficient bone quality in the humerus bone intraoperatively via the thumb test, guide pin test, humeral punch test, and humeral anchor test as outlined in the surgical technique.
Patients with an adjusted Constant Score < 60 and ≥ 15.
Patients are willing and able to comply with the follow-up schedule and evaluation outlined in the protocol.
Patient are willing and able to sign the informed consent.
Exclusion criteria
Primary purpose
Allocation
Interventional model
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90 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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