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Orthopedic Implant
Easytech Reversed Shoulder System for Shoulder Osteoarthritis
N/A
Waitlist Available
Research Sponsored by FX Shoulder Solutions
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients have a functional deltoid muscle
Patients have a massive and non-repairable rotator cuff tear
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial is testing a new shoulder replacement system to see if it is safe and effective.
Who is the study for?
This trial is for adults over 21 with severe shoulder issues like massive, non-repairable rotator cuff tears or certain types of arthritis. They must have a specific level of shoulder function (adjusted Constant Score < 60 and ≥ 15), be able to follow the study's schedule, and have good bone quality in their humerus. People with very high BMI (>40 kg/m2), active infections, immune deficiencies, heavy steroid use, severe other illnesses (ASA score >3), substance abuse problems, or mental conditions that affect survey completion cannot join.Check my eligibility
What is being tested?
The Easytech Reversed Shoulder System is being tested to see if it's safe and effective for reverse total shoulder arthroplasty—a type of shoulder replacement surgery—in patients who meet the criteria.See study design
What are the potential side effects?
While not explicitly listed in the provided information, typical side effects from similar surgical implants may include pain at the implant site, swelling, infection risk around the area operated on, possible damage to nearby nerves or blood vessels during surgery and potential complications leading to further surgeries.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My shoulder muscle works normally.
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I have a severe, unfixable tear in my shoulder tendon.
Select...
I am 21 years old or older.
Select...
My bones have fully grown, including in my shoulder area.
Select...
I need shoulder replacement surgery due to arthritis or bone death.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adjusted Constant-Murley Score
no humeral radiolucency >2mm around the humeral component
no revision
+2 moreSecondary outcome measures
American Shoulder and Elbow Surgeon (ASES)
QuickDASH
Range of Motion of the shoulder joint
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Easytech groupExperimental Treatment1 Intervention
patients who require a reverse total shoulder, meet the eligibility criteria and receive the Easytech Reversed Shoulder System
Find a Location
Who is running the clinical trial?
FX Shoulder SolutionsLead Sponsor
2 Previous Clinical Trials
1,200 Total Patients Enrolled
FX Shoulder USA, Inc.Lead Sponsor
Kathy Trier, PhDStudy DirectorFX Shoulder Solutions
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My bones are too weak to support an implant.I have a fracture in my shoulder area.I currently have active cancer.I have had fractures from minor injuries.My shoulder muscle works normally.My shoulder muscle works normally.I do not have an active infection or a history of joint infection in my shoulder.I have a bone condition like osteoporosis or Paget's disease.I have a severe, unfixable tear in my shoulder tendon.I need my hands to stand up from a sitting position.I have not taken more than 5mg/day of corticosteroids, except inhalers, in the last 3 months.I have a severe injury or disease affecting my upper arm's nerves.My body is suitable for implants as determined by surgical tests.I have circulation problems like blood clots or swollen limbs.I am 21 years old or older.I can follow the study's schedule and tests.My bones have fully grown, including in my shoulder area.I need shoulder replacement surgery due to arthritis or bone death.I have a severe shoulder injury that cannot be surgically repaired.
Research Study Groups:
This trial has the following groups:- Group 1: Easytech group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Rotator Cuff Tears Patient Testimony for trial: Trial Name: NCT03806842 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What goals has this experiment been designed to achieve?
"This 24-month clinical trial aims to determine whether the humeral component has subsided or migrated more than 5mm. Evaluative metrics include patient responses on function and pain (ASES), range of motion in forward and lateral elevation, internal/external rotation arm at side (ROM) as well as QuickDASH scores that measure the ability to complete tasks, absorb forces and symptom severity."
Answered by AI
Is this trial currently recruiting participants?
"According to clinicaltrials.gov, this research study is not actively recruiting participants at the moment; it was first posted on November 28th 2018 and last edited on June 20th 2022. However, there are currently 768 other trials openly accepting patients for enrollment."
Answered by AI
How many sites are overseeing this research project?
"Currently, 6 sites are participating in this investigation - Orthopedics Rhode island (Wakefield), Texas Orthopaedic Specialists (Bedford) and The CORE Institute (Sun City West). There are also three additional medical facilities enrolled."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
What site did they apply to?
University of Pennsylvania
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
What questions have other patients asked about this trial?
How long is the trial? What's involved? Is it conducted onsite, offsite, or both?
PatientReceived no prior treatments
Why did patients apply to this trial?
I applied to be a help to science but also to see if there is something that can help with my growing shoulder pain.
PatientReceived no prior treatments
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