Status:
UNKNOWN
Easytech Reversed Shoulder System Clinical Study
Lead Sponsor:
FX Shoulder Solutions
Conditions:
Osteo Arthritis Shoulders
Avascular Necrosis of the Head of Humerus
Eligibility:
All Genders
21+ years
Phase:
NA
Brief 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 arth...
Detailed 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-repairab...
Eligibility Criteria
Inclusion
- 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
- 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.
- 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.
- Patients with significant comorbidities as evident by an American Society of Anesthesiologists (ASA) score greater than 3.
- Patients with active neoplastic disease.
- Patients with current drug or alcohol abuse, or a history of the same within the last 6 months.
- Patients with local circulatory problems, (e.g. thrombophlebitis and lymphedema).
- Patients are pregnant or expect to become pregnant during the duration of the study.
- Patients with any mental or psychological disorder that would impair their ability to complete the study questionnaires.
- Patients with any medical condition or other circumstances that might interfere with their ability to return for follow-up visits in the judgment of the Investigator, including any systemic illness, neuromuscular, neurosensory, or musculoskeletal deficiency that would render the patient unable to perform appropriate postoperative rehabilitation.
- Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of device's safety and performance.
- Patients with humeral or glenoid fractures.
- Patients unable to stand from sitting position without the use of their hands/arms.
- Patients with a history of fragility fractures as defined as any fall from a standing height or less, that results in a fracture.
- Patients with osteoporosis, osteopenia, Paget's disease, osteomalacia or any other metabolic bone disease; a. Osteoporosis is defined as Simple Calculated Osteoporosis Risk Estimation (SCORE) above 6 and DXA (Dual-energy X-ray absorptiometry) T-score \< -2.5 or QCT (Quantitative computed tomography) T-score \< 80mg/cubic cm. History of a fragility fracture requires that a DXA scan or QCT scan is completed.
Key Trial Info
Start Date :
November 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 28 2024
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03806842
Start Date
November 28 2018
End Date
December 28 2024
Last Update
September 28 2023
Active Locations (6)
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1
The CORE Institute
Sun City West, Arizona, United States, 85375
2
Dearborn & Associates Institute for Joint Reconstruction
Menlo Park, California, United States, 94027
3
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
4
Orthopedics Rhode Island
Wakefield, Rhode Island, United States, 02879