Easytech Reversed Shoulder System Clinical Study

Rotator Cuff Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03806842
• Other study ID #: FXUSA2018-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 28, 2018
• Est. completion date: December 28, 2024

Study information

• Verified date: September 2023
• Source: FX Shoulder Solutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: December 28, 2024
• Est. primary completion date: December 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Avascular Necrosis of the Head of Humerus
• Necrosis
• Osteo Arthritis Shoulders
• Osteoarthritis
• Rotator Cuff Injuries
• Rotator Cuff Tear

Intervention

Device:
• Easytech group
total shoulder replacement

Locations

Country	Name	City	State
United States	Texas Orthopedic Specialists	Bedford	Texas
United States	Carrell Clinic	Dallas	Texas
United States	Dearborn & Associates Institute for Joint Reconstruction	Menlo Park	California
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	The CORE Institute	Sun City West	Arizona
United States	Orthopedics Rhode Island	Wakefield	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
FX Shoulder Solutions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	no revision	there is no revision of the humeral components	24 months post-operative
Primary	no serious device related adverse event	there is no serious device related adverse event reported	24 months post-operative
Secondary	QuickDASH	measures the ability to complete tasks, absorb forces and severity of symptoms	24 months post-operative
Secondary	Visual Analog Scale for Pain (VAS)	on 100 point scale where 0 is no pain and 100 is severe pain	24 months post-operative
Secondary	American Shoulder and Elbow Surgeon (ASES)	patient-reported outcomes with questions on function and pain	24 months post-operative
Secondary	Range of Motion of the shoulder joint	forward and lateral elevation, internal & external rotation arm at side	24 months

External Links

•   Company website