- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03806842
Easytech Reversed Shoulder System Clinical Study
Pivotal, Non-Randomized, Historically Controlled, Prospective, Multi-Center Clinical Study of the Easytech Reversed Shoulder System
Study Overview
Status
Intervention / Treatment
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-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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arizona
-
Sun City West, Arizona, United States, 85375
- The Core Institute
-
-
California
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Menlo Park, California, United States, 94027
- Dearborn & Associates Institute for Joint Reconstruction
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
-
-
Rhode Island
-
Wakefield, Rhode Island, United States, 02879
- Orthopedics Rhode Island
-
-
Texas
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Bedford, Texas, United States, 76021
- Texas Orthopedic Specialists
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Dallas, Texas, United States, 75231
- Carrell Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Easytech group
patients who require a reverse total shoulder, meet the eligibility criteria and receive the Easytech Reversed Shoulder System
|
total shoulder replacement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adjusted Constant-Murley Score
Time Frame: 24 months post-operative
|
adjusted Constant Score of 70 or greater, no humeral radiolucency >2mm or humeral migration/subsidence >5mm, no revision surgery, no serious device related adverse event
|
24 months post-operative
|
no humeral radiolucency >2mm around the humeral component
Time Frame: 24 months post-operative
|
on review of x-rays, there are no radiolucencies >2mm around the humeral component
|
24 months post-operative
|
no subsidence or migration of the humeral component >5mm
Time Frame: 24 months post-operative
|
on review of x-rays, there is no subsidence or migration of the humeral component greater than or equal to 5mm
|
24 months post-operative
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no revision
Time Frame: 24 months post-operative
|
there is no revision of the humeral components
|
24 months post-operative
|
no serious device related adverse event
Time Frame: 24 months post-operative
|
there is no serious device related adverse event reported
|
24 months post-operative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
QuickDASH
Time Frame: 24 months post-operative
|
measures the ability to complete tasks, absorb forces and severity of symptoms
|
24 months post-operative
|
Visual Analog Scale for Pain (VAS)
Time Frame: 24 months post-operative
|
on 100 point scale where 0 is no pain and 100 is severe pain
|
24 months post-operative
|
American Shoulder and Elbow Surgeon (ASES)
Time Frame: 24 months post-operative
|
patient-reported outcomes with questions on function and pain
|
24 months post-operative
|
Range of Motion of the shoulder joint
Time Frame: 24 months
|
forward and lateral elevation, internal & external rotation arm at side
|
24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Kathy Trier, PhD, FX Shoulder Solutions
- Study Director: Brian Rogers, BS, FX Shoulder Solutions
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FXUSA2018-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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