Easytech Reversed Shoulder System Clinical Study

September 25, 2023 updated by: FX Shoulder Solutions

Pivotal, Non-Randomized, Historically Controlled, Prospective, Multi-Center Clinical Study of the Easytech Reversed Shoulder System

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.

Study Overview

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

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arizona
      • Sun City West, Arizona, United States, 85375
        • The Core Institute
    • California
      • Menlo Park, California, United States, 94027
        • Dearborn & Associates Institute for Joint Reconstruction
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Rhode Island
      • Wakefield, Rhode Island, United States, 02879
        • Orthopedics Rhode Island
    • Texas
      • Bedford, Texas, United States, 76021
        • Texas Orthopedic Specialists
      • Dallas, Texas, United States, 75231
        • Carrell Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Kathy Trier, PhD, FX Shoulder Solutions
  • Study Director: Brian Rogers, BS, FX Shoulder Solutions

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2018

Primary Completion (Estimated)

December 28, 2024

Study Completion (Estimated)

December 28, 2024

Study Registration Dates

First Submitted

December 31, 2018

First Submitted That Met QC Criteria

January 14, 2019

First Posted (Actual)

January 16, 2019

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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