Osteo Arthritis ShouldersNCT03806842
Easytech Reversed Shoulder System Clinical Study
A study testing Easytech group in people with Osteo Arthritis Shoulders and Avascular Necrosis of the Head of Humerus, run by FX Shoulder Solutions at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteo Arthritis Shoulders, Avascular Necrosis of the Head of Humerus, Rotator Cuff Tear
- What is being tested?
- Easytech group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 6 sitesUnited States
- Study dates
- 28 Nov 2018to 28 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
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- 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.
- Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of device's safety and performance.
- Patients with humeral or glenoid fractures.
- Patients unable to stand from sitting position without the use of their hands/arms.
- Patients with a history of fragility fractures as defined as any fall from a standing height or less, that results in a fracture.
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Texas Orthopedic Specialists
Bedford, Texas, 76021
Carrell Clinic
Dallas, Texas, 75231
Dearborn & Associates Institute for Joint Reconstruction
Menlo Park, California, 94027
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
The CORE Institute
Sun City West, Arizona, 85375
Orthopedics Rhode Island
Wakefield, Rhode Island, 02879
About this study
Official title: 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.
Read the 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.
- Being tested
- Easytech group
- Keywords
- shoulder arthroplasty, reverse shoulder replacement
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Easytech groupDevice
total shoulder replacement
| Study group | Role | What they receive |
|---|---|---|
| Easytech group | Other | patients who require a reverse total shoulder, meet the eligibility criteria and receive the Easytech Reversed Shoulder System Receives: Device: Easytech group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 24 months post-operative
no revision
there is no revision of the humeral components
Measured: 24 months post-operative
no serious device related adverse event
there is no serious device related adverse event reported
Measured: 24 months post-operative
Secondary outcomes (4)
QuickDASH
measures the ability to complete tasks, absorb forces and severity of symptoms
Measured: 24 months post-operative
Visual Analog Scale for Pain (VAS)
on 100 point scale where 0 is no pain and 100 is severe pain
Measured: 24 months post-operative
American Shoulder and Elbow Surgeon (ASES)
patient-reported outcomes with questions on function and pain
Measured: 24 months post-operative
Range of Motion of the shoulder joint
forward and lateral elevation, internal \& external rotation arm at side
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start28 Nov 2018
- Primary completion28 Dec 2024 (estimated)
- Study completion28 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis ShouldersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single arm, historically controlled, multi-center
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FX Shoulder Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kathy Trier, PhD, Study director, FX Shoulder SolutionsBrian Rogers, BS, Study director, FX Shoulder Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806842
- Sponsor's protocol ID
- FXUSA2018-01
- Status last verified
- Sep 2023
- First submitted
- 31 Dec 2018
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal, Non-Randomized, Historically Controlled, Prospective, Multi-Center Clinical Study of the Easytech Reversed Shoulder System
- ClinicalTrials.gov ID
- NCT03806842
- Acronym / sponsor ID
- FXUSA2018-01
- Keywords
- shoulder arthroplasty, reverse shoulder replacement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- FX Shoulder SolutionsIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 28 Dec 2024 (estimated)
- Study completion
- 28 Dec 2024 (estimated)
- First posted
- 16 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single arm, historically controlled, multi-center
| Arm | Type | Receives |
|---|---|---|
| Easytech group | Other | Device: Easytech grouppatients who require a reverse total shoulder, meet the eligibility criteria and receive the Easytech Reversed Shoulder System |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Easytech grouptotal shoulder replacement | Device | Easytech group |
Primary outcome
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
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
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
no revision
Time frame: 24 months post-operative
there is no revision of the humeral components
no serious device related adverse event
Time frame: 24 months post-operative
there is no serious device related adverse event reported
4 secondary outcomes
QuickDASH
Time frame: 24 months post-operative
Visual Analog Scale for Pain (VAS)
Time frame: 24 months post-operative
American Shoulder and Elbow Surgeon (ASES)
Time frame: 24 months post-operative
Range of Motion of the shoulder joint
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Company websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathy Trier, PhD study director
FX Shoulder Solutions
Brian Rogers, BS study director
FX Shoulder Solutions
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Easytech group in people with Osteo Arthritis Shoulders and Avascular Necrosis of the Head of Humerus, run by FX Shoulder Solutions at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adjusted Constant-Murley Score (time frame: 24 months post-operative). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.