FX Shoulder Solutions Retrospective / 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: Rotator Cuff Syndrome of Shoulder and Allied Disorders, Osteoarthritis Shoulder, 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 →
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Overview
Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions and distributed by FX Shoulder Solutions.
Detailed description
To evaluate patient outcomes following shoulder replacement with FX Shoulder Solutions medical devices To 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.
Clinical data in the Investigator's clinic notes and patient files regarding demographics, baseline medical and shoulder status, surgical procedure and implant components, and any completed postoperative clinical data will be collected retrospectively as data for the Study following signed patient consent and enrollment into the study.
Each patient will be evaluated prospectively, and clinical data collected at the first baseline clinical evaluation using the protocol specified evaluations following study enrollment with successive postoperative evaluations in accordance with the postoperative intervals.
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, PRCT II Fracture Plate, V-135
Primary outcome measures
- Number of participants who are at a minimum of 2 years postoperative follow-up based upon the following composite clinical success (CCS) of the Patient Reported Outcome Surveys and Investigator Range of Motion (ROM) assessments. [Time frame: 10 years]
Secondary outcome measures (10)
- Adjusted Constant Score [Time frame: 3, 6, 12, 24 months, 5 and 10 years.]
- QuickDASH [Time frame: 3, 6, 12, 24 months, 5 and 10 years.]
- American Shoulder and Elbow Surgeon (ASES) [Time frame: 3, 6, 12, 24 months, 5 and 10 years.]
- Visual Analog Scale (VAS). A validated measurement of pain in a patient where 0 indicates no pain and 100 indicates severe pain. The VAS is a straight horizontal line of fixed length. [Time frame: 3, 6, 12, 24 months, 5 and 10 years]
- Range of Motion [Time frame: 3, 6, 12, 24 months, 5 and 10 years.]
- Number of Participants Who Have a Secondary Surgical Intervention (SSI) [Time frame: 24 months and at 5 and 10 years]
- Device Related Adverse Events. [Time frame: 24 months and at 5 and 10 years postoperative]
- Serious Adverse Event [Time frame: 24 months and at 5 and 10 years postoperative]
- Serious Adverse Device Effects (SADE) [Time frame: 24 months and at 5 and 10 years postoperative.]
- Number of Participants with Radiographic Reviews and Assessments. [Time frame: 24 months, at 5 years and 10 years postoperative]
Eligibility 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
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
- Other
Study locations
United States · 2 centers
- OrthoArizona — Gilbert
- Advanced Orthopedics Institute — The Villages
Identifiers
NCT: NCT06077942 · FXShoulder2022-01