FX Shoulder Prospective Clinical Study for Shoulder Conditions
This observational study is looking at how well different FX Artificial Shoulder Prosthesis devices work for people with shoulder osteoarthritis, rotator cuff syndrome, or shoulder fractures. The devices being studied include the Humelock II Anatomic, Humelock II Reversible, Humelock Reverse, Humeris, Easytech Anatomical, FXV135 Mini, and FXV135 Humelock Shoulder Systems. To join, you must receive one of these FX shoulder replacement devices. The study will look at how successful the treatment is after 2 years, based on improvements in shoulder function, no device problems, and no need for more surgery. It will also track how long the devices last for up to 10 years. The current recruitment status is unclear.
- Study design
- This is an observational study involving 600 participants. It is designed to evaluate patient outcomes after receiving an FX shoulder replacement device.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for at least 2 years to assess clinical success, and then for up to 10 years to track device survivorship.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
FX Shoulder Prospective Clinical Study
At a glance
Conditions
NCT06078865
Where you'd take part
This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
First Settlement Orthopedics
Marietta, Ohiostudy coordinator listed
Recruiting
OrthoArizona
Gilbert, Arizonastudy coordinator listed
Recruiting
Orthopedics Rhode Island
Wakefield, Rhode Islandstudy coordinator listed
Recruiting
Texas Orthopedic Specialists
Bedford, Texasstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Kathy Trier, PhD · STUDY_DIRECTOR · FX Shoulder Solutions
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- A patient is considered a success at post-operative follow-up based upon the following composite clinical success (CCS):2 years
Adjusted Constant Score that is ≥ 54 and improvement of ≥ 10 points from baseline. No continuous radiolucency or device migration/subsidence No revision surgery No serious device related adverse event.
- Survivorship10 years
Follow patient's post-operative to track survivorship.