FX Shoulder Prospective Clinical Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FX Artificial Shoulder Prosthesis.
- Who it may be relevant to
- Registry conditions: Osteoarthritis Shoulder, Rotator Cuff Syndrome of Shoulder and Allied Disorders, Fracture, Shoulder. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
FX Shoulder Post-Market Follow-Up Clinical Study
Overview
Prospective Multi-Center Registry on study subjects with implanted devices marketed and legally commercialized in the USA by FX Shoulder Solutions.
Detailed description
To evaluate patient outcomes following shoulder replacement with FX Shoulder Solutions medical devices and demonstrate effectiveness, safety and survivorship of FX Shoulder Solutions medical devices.
To provide data and analysis to FX Shoulder Solutions to meet regulatory requirements.
To provide data and analysis for presentations, abstracts, publications and other public release of results.
A patient is considered a success at minimum of 2 years post-operative follow-up based upon the following composite clinical success (CCS):
* 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
The Registry will continue to follow patients to 10 years post-operative to track survivorship.
Interventions
- Device FX Artificial Shoulder Prosthesis
Humelock II Anatomic Shoulder System, Humelock II Reversible Shoulder System, Humelock Reverse Shoulder System, Humeris Shoulder System, Easytech Anatomical Shoulder System, FXV135 Mini Shoulder System, FXV135 Humelock Shoulder System
Primary outcome measures
- A patient is considered a success at post-operative follow-up based upon the following composite clinical success (CCS): [Time frame: 2 years]
- Survivorship [Time frame: 10 years]
Secondary outcome measures (10)
- Adjusted Constant Score [Time frame: 6 weeks, 3, 6, 12, and 24 months.]
- QuickDASH [Time frame: 6 weeks, 3, 6, 12, and 24 months.]
- American Shoulder and Elbow Surgeon (ASES) [Time frame: 6 weeks, 3, 6, 12, and 24 months]
- Visual Analog Scale (VAS). [Time frame: 6 weeks, 3, 6, 12, and 24 months]
- Range of Motion (ROM) [Time frame: 6 weeks, 3, 6, 12, and 24 months]
- Secondary Surgical Interventions (SSI) [Time frame: 24 months and at 5 years postoperative]
- Serious Adverse Event [Time frame: 24 months and at 5 years postoperative]
- Serious Adverse Device Effects (SADE) [Time frame: 24 months and at 5 years postoperative.]
- Radiographic Reviews and Assessments. [Time frame: 24 months and at 5 years postoperative.]
- Survival [Time frame: 24 months and at 5 years]
Eligibility criteria
Inclusion criteria
Receive an FX shoulder replacement medical device in accordance with the Indications for Use for the selected device system.
Exclusion criteria
Patient who does not meet the inclusion criteria.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 4 centers
- OrthoArizona — Gilbert
- First Settlement Orthopedics — Marietta
- Orthopedics Rhode Island — Wakefield
- Texas Orthopedic Specialists — Bedford
Identifiers
NCT: NCT06078865 · FXShoulder2020-01 · FXShoulder2020-1