UnknownNot Applicable

Easytech Reversed Shoulder System Clinical Study

United States90 participantsStarted 2018-11-28

Plain-language 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.

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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;
. 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.

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adjusted Constant-Murley Score

Timeframe: 24 months post-operative

no humeral radiolucency >2mm around the humeral component

Timeframe: 24 months post-operative

no subsidence or migration of the humeral component >5mm

Timeframe: 24 months post-operative

no revision

Timeframe: 24 months post-operative

no serious device related adverse event

Timeframe: 24 months post-operative

Trial details

NCT IDNCT03806842

SponsorFX Shoulder Solutions

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-28

View on ClinicalTrials.gov More Osteo Arthritis Shoulders trials

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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;
. 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.

Exclusion criteria

. 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.

What they're measuring

Adjusted Constant-Murley Score

Timeframe: 24 months post-operative

no humeral radiolucency >2mm around the humeral component

Timeframe: 24 months post-operative

no subsidence or migration of the humeral component >5mm

Timeframe: 24 months post-operative

no revision

Timeframe: 24 months post-operative

no serious device related adverse event

Timeframe: 24 months post-operative