Clinical trial Recruiting at 1 site Observational

Evaluating outcomes of FX Shoulder Solutions implants for shoulder conditions

Official title: FX Shoulder Solutions Retrospective / Prospective Clinical Study

Run by FX Shoulder Solutions · NCT06077942 · Data updated 2026-11-12

This study is testing how well FX Shoulder Solutions implants work for people who have had shoulder replacement surgeries to see if they help patients recover safely and effectively.

Quick facts

Study typeObservational
SexAll
Enrollment600 (estimated)
SponsorFX Shoulder Solutions
Industry-sponsored
Locations2 sites (Gilbert, Arizona and 1 other locations)
StatusRecruiting
StartedDecember 6, 2022
Main results expectedDecember 30, 2032
Study endsDecember 30, 2032
Registry record updatedOctober 12, 2023
Trial IDNCT06077942 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients who have received an FX Shoulder Solutions replacement device between January 1, 2018, and June 30, 2023.

Probably not a fit

Patients who have not received an FX Shoulder Solutions replacement device or do not meet the inclusion criteria will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate patient outcomes following shoulder replacement surgeries using FX Shoulder Solutions medical devices. It will collect both retrospective and prospective clinical data, including demographics, baseline medical status, surgical procedures, and postoperative evaluations. The study seeks to demonstrate the effectiveness, safety, and survivorship of these implants while providing necessary data for regulatory compliance and future presentations. Patient consent is required for enrollment, and evaluations will occur at specified postoperative intervals.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of the effectiveness and safety of FX Shoulder Solutions implants, potentially improving patient outcomes in shoulder surgeries.

How similar studies have gone: While this study focuses on a specific brand of shoulder implants, similar observational studies have shown success in evaluating outcomes of shoulder replacements, indicating a potential for valuable insights.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Received an FX Shoulder Solutions replacement medical device in accordance with the Indications for Use based upon surgeons' determination and standard of care for the selected device system beginning January 1, 2018, through June 30, 2023.

Exclusion Criteria:

* Patient who does not meet the inclusion criteria above

Where it's running

  • Advanced Orthopedics Institute
    The Villages, Florida, United States
    Recruiting
  • OrthoArizona
    Gilbert, Arizona, United States
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Registry to evaluate outcomes of FX Shoulder replacement devices

    This study is setting up a registry to see how well FX Shoulder replacement devices work for patients after their surgeries over the next few years.

    Recruiting at 4 sites FX Shoulder Solutions · Gilbert, Arizona and 3 other locations · NCT06078865

  • Diaphragm-sparing regional anesthesia for shoulder surgery

    This study tests whether a suprascapular and infraclavicular nerve block can provide good shoulder surgery pain relief without causing diaphragm problems, compared with the standard interscalene block, in older adults.

    Recruiting Poznan University of Medical Sciences · Poznan · NCT07474896

  • Lengthening a tendon to reduce shoulder pain after surgery

    This study is testing if lengthening a tendon during shoulder surgery can help reduce pain in patients one year after their operation.

    Recruiting Loyola University · Maywood, Illinois · NCT06729983

  • National Registry for Artery Embolization to Treat Chronic Pain

    This study is testing if a procedure that blocks blood flow to painful areas can help people with chronic pain from osteoarthritis and other conditions feel better.

    Recruiting at 2 sites Vascular Solutions of North Carolina · Cary, North Carolina and 1 other locations · NCT06477965

  • Comparing two shoulder surgeries for older patients with osteoarthritis

    This study is testing which shoulder surgery works better for older patients with severe arthritis: a total shoulder replacement or a reverse shoulder replacement.

    Recruiting Ottawa Hospital Research Institute · Ottawa, Ontario · NCT05487274

  • Evaluation of the PERFORM™ Humeral System for shoulder conditions

    This study is testing how safe and effective the PERFORM™ Humeral System is for people who have had shoulder surgery by tracking their recovery and quality of life over the next ten years.

    Recruiting at 5 sites Stryker Trauma and Extremities · Lexington, Kentucky and 10 other locations · NCT05067543

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.