Easytech Reversed Shoulder System Clinical Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 21 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patients are 21 years or older. 2. Patients are skeletally mature as evident by scapula and proximal humerus closure. 3. 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. 4. Patients have a massive and non-repairable rotator cuff tear. 5. Patients have a functional deltoid muscle. 6. 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. 7. Patients with an adjusted Constant Score < 60 and ≥ 15. 8. Patients are willing and able to comply with the follow-up schedule and evaluation outlined in the protocol. 9. Patient are willing and able to sign the informed consent.

Exclusion Criteria:

1. Patients with Body Mass Index (BMI) greater than 40 kg/m2. 2. 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. 3. Patients have marked bone loss that would not allow sufficient support of the implant. 4. Patients have a known sensitivity or allergic reaction to one or more of the implanted materials. 5. 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. 6. 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. 7. Patients with known immunodeficiency. 8. Patients currently taking > 5mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery. 9. Patients with significant comorbidities as evident by an American Society of Anesthesiologists (ASA) score greater than 3. 10. Patients with active neoplastic disease. 11. Patients with current drug or alcohol abuse, or a history of the same within the last 6 months. 12. Patients with local circulatory problems, (e.g. thrombophlebitis and lymphedema). 13. Patients are pregnant or expect to become pregnant during the duration of the study. 14. Patients with any mental or psychological disorder that would impair their ability to complete the study questionnaires. 15. 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. 16. Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of device's safety and performance. 17. Patients with humeral or glenoid fractures. 18. Patients unable to stand from sitting position without the use of their hands/arms. 19. Patients with a history of fragility fractures as defined as any fall from a standing height or less, that results in a fracture. 20. 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03806842
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

FX Shoulder USA, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Kathy Trier, PhD
Principal Investigator Affiliation FX Shoulder USA, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Osteo Arthritis Shoulders, Avascular Necrosis of the Head of Humerus, Rotator Cuff Tear
Additional Details

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.

Arms & Interventions

Arms

Experimental: Easytech group

patients who require a reverse total shoulder, meet the eligibility criteria and receive the Easytech Reversed Shoulder System

Interventions

Device: - Easytech group

total shoulder replacement

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

The CORE Institute, Sun City West, Arizona

Status

Recruiting

Address

The CORE Institute

Sun City West, Arizona, 85375

Site Contact

Susan Mauro

[email protected]

623-455-7125

Menlo Park, California

Status

Recruiting

Address

Dearborn & Associates Institute for Joint Reconstruction

Menlo Park, California, 94027

Site Contact

Luisa Manfredi, MPH JD

[email protected]

315-420-0312

University of Pennsylvania, Philadelphia, Pennsylvania

Status

Recruiting

Address

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Site Contact

Tamara Rial

[email protected]

215-987-8984

Orthopedics Rhode Island, Wakefield, Rhode Island

Status

Recruiting

Address

Orthopedics Rhode Island

Wakefield, Rhode Island, 02879

Site Contact

Jennifer Devoe

[email protected]

214.890.4109

Texas Orthopedic Specialists, Bedford, Texas

Status

Recruiting

Address

Texas Orthopedic Specialists

Bedford, Texas, 76021

Site Contact

Amber Morgan, MD

[email protected]

817-510-4022

Carrell Clinic, Dallas, Texas

Status

Recruiting

Address

Carrell Clinic

Dallas, Texas, 75231

Site Contact

Kathy Trier, PhD

[email protected]

214.890.4109