Easytech Reversed Shoulder System Clinical Study (NCT03806842) | Clinical Trial Compass
UnknownNot Applicable
Easytech Reversed Shoulder System Clinical Study
United States90 participantsStarted 2018-11-28
Plain-language summary
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.
Who can participate
Age range21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
✓. 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.
Exclusion criteria
✕. Patients with Body Mass Index (BMI) greater than 40 kg/m2.
✕. Patients have one of the following compromising the affected limb: a significant injury to the upper brachial plexus, paralysis of the axillary nerve or a neuromuscular disease compromising the affected limb which would render the procedure unjustifiable.
✕. Patients have marked bone loss that would not allow sufficient support of the implant.
✕. Patients have a known sensitivity or allergic reaction to one or more of the implanted materials.
What they're measuring
1
Adjusted Constant-Murley Score
Timeframe: 24 months post-operative
2
no humeral radiolucency >2mm around the humeral component
Timeframe: 24 months post-operative
3
no subsidence or migration of the humeral component >5mm
✕. Patients who are participating concurrently in another clinical study, or have participated in a clinical study within the last 90 days, or intend to during the course of the study.
✕. Patients who have an active systemic infection, or an active local infection in or near the target shoulder, or have a previous history of joint infection.
✕. Patients with known immunodeficiency.
✕. Patients currently taking \> 5mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery.