Easytech Reversed Shoulder System Clinical Study

NCT03806842 | Unknown DMC FDA Device

• 1 other identifier: FXUSA2018-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Osteo Arthritis Shoulders; Avascular Necrosis of the Head of Humerus; Rotator Cuff Tear

Keywords

shoulder arthroplasty; reverse shoulder replacement

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (4)

• QuickDASH

  24 months post-operative

• Visual Analog Scale for Pain (VAS)

  24 months post-operative

• American Shoulder and Elbow Surgeon (ASES)

  24 months post-operative

• Range of Motion of the shoulder joint

  24 months

Study Arms (1)

Easytech group

OTHER

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

Device: Easytech group

Interventions

Easytech group DEVICE

total shoulder replacement

Easytech group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with Body Mass Index (BMI) greater than 40 kg/m2.
• 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.
• Patients have marked bone loss that would not allow sufficient support of the implant.
• Patients have a known sensitivity or allergic reaction to one or more of the implanted materials.
• 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.
• 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.
• Patients with known immunodeficiency.
• Patients currently taking \> 5mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery.
• Patients with significant comorbidities as evident by an American Society of Anesthesiologists (ASA) score greater than 3.
• Patients with active neoplastic disease.
• Patients with current drug or alcohol abuse, or a history of the same within the last 6 months.
• Patients with local circulatory problems, (e.g. thrombophlebitis and lymphedema).
• Patients are pregnant or expect to become pregnant during the duration of the study.
• Patients with any mental or psychological disorder that would impair their ability to complete the study questionnaires.
• 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.

Sponsors & Collaborators

• FX Shoulder Solutions: lead

Study Sites (6)

The CORE Institute

Sun City West, Arizona, 85375, United States

Location

Dearborn & Associates Institute for Joint Reconstruction

Menlo Park, California, 94027, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Orthopedics Rhode Island

Wakefield, Rhode Island, 02879, United States

Location

Texas Orthopedic Specialists

Bedford, Texas, 76021, United States

Location

Carrell Clinic

Dallas, Texas, 75231, United States

Location

Related Links

• Company website

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Kathy Trier, PhD

  FX Shoulder Solutions

  STUDY DIRECTOR

• Brian Rogers, BS

  FX Shoulder Solutions

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: no masking due to being a single arm study
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: single arm, historically controlled, multi-center

Study Record Dates

• First Submitted: December 31, 2018
• First Posted: January 16, 2019
• Study Start: November 28, 2018
• Primary Completion: December 28, 2024
• Study Completion: December 28, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

US (6)