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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Easytech group | Other | patients who require a reverse total shoulder, meet the eligibility criteria and receive the Easytech Reversed Shoulder System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Easytech group | Device | total shoulder replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Constant-Murley Score | 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 | 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 | 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 |
| no revision | there is no revision of the humeral components | 24 months post-operative |
| no serious device related adverse event | there is no serious device related adverse event reported | 24 months post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| QuickDASH | measures the ability to complete tasks, absorb forces and severity of symptoms | 24 months post-operative |
| Visual Analog Scale for Pain (VAS) | on 100 point scale where 0 is no pain and 100 is severe pain |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Kathy Trier, PhD | FX Shoulder Solutions | Study Director |
| Brian Rogers, BS | FX Shoulder Solutions | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The CORE Institute | Sun City West | Arizona | 85375 | United States | ||
| Dearborn & Associates Institute for Joint Reconstruction |
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| Label | URL |
|---|---|
| Company website | View source |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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single arm, historically controlled, multi-center
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no masking due to being a single arm study
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| 24 months post-operative |
| American Shoulder and Elbow Surgeon (ASES) | patient-reported outcomes with questions on function and pain | 24 months post-operative |
| Range of Motion of the shoulder joint | forward and lateral elevation, internal & external rotation arm at side | 24 months |
| Menlo Park |
| California |
| 94027 |
| United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Orthopedics Rhode Island | Wakefield | Rhode Island | 02879 | United States |
| Texas Orthopedic Specialists | Bedford | Texas | 76021 | United States |
| Carrell Clinic | Dallas | Texas | 75231 | United States |