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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
Must not have
Patients with marked bone loss that would not allow sufficient support of the implant
Patients with humeral or glenoid fractures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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My shoulder muscle works normally.
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I have a severe, unfixable tear in my shoulder tendon.
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I am 21 years old or older.
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My bones have fully grown, including in my shoulder area.
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I need shoulder replacement surgery due to arthritis or bone death.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My bones are too weak to support an implant.
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I have a fracture in my shoulder area.
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I currently have active cancer.
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I have had fractures from minor injuries.
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I do not have an active infection or a history of joint infection in my shoulder.
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I have a bone condition like osteoporosis or Paget's disease.
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I need my hands to stand up from a sitting position.
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I have not taken more than 5mg/day of corticosteroids, except inhalers, in the last 3 months.
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I have a severe injury or disease affecting my upper arm's nerves.
Select...
I have circulation problems like blood clots or swollen limbs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adjusted Constant-Murley Score
no humeral radiolucency >2mm around the humeral component
no revision
+2 more
Secondary study objectives
American Shoulder and Elbow Surgeon (ASES)
QuickDASH
Range of Motion of the shoulder joint
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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

Easytech Reversed Shoulder System (Orthopedic Implant) Clinical Trial Eligibility Overview. Trial Name: NCT03806842 — N/A
Rotator Cuff Tears Research Study Groups: Easytech group
Rotator Cuff Tears Clinical Trial 2023: Easytech Reversed Shoulder System Highlights & Side Effects. Trial Name: NCT03806842 — N/A
Easytech Reversed Shoulder System (Orthopedic Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03806842 — N/A
Rotator Cuff Tears Patient Testimony for trial: Trial Name: NCT03806842 — N/A
~1 spots leftby Dec 2024
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