FX Shoulder Solutions Retrospective / Prospective Clinical Study
1 other identifier
observational
600
1 country
2
Brief Summary
Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions and distributed by FX Shoulder Solutions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2022
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 6, 2022
CompletedFirst Submitted
Initial submission to the registry
September 26, 2023
CompletedFirst Posted
Study publicly available on registry
October 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2032
October 12, 2023
October 1, 2023
10.1 years
September 26, 2023
October 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
* Adjusted Constant Score \> 70 * No continuous radiolucency or device migration/subsidence * No revision surgery or removal * No serious device related adverse event The Study will continue to follow patients prospectively to 10 years postoperative to track survivorship.
10 years
Secondary Outcomes (10)
Adjusted Constant Score
3, 6, 12, 24 months, 5 and 10 years.
QuickDASH
3, 6, 12, 24 months, 5 and 10 years.
American Shoulder and Elbow Surgeon (ASES)
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.
3, 6, 12, 24 months, 5 and 10 years
Range of Motion
3, 6, 12, 24 months, 5 and 10 years.
- +5 more secondary outcomes
Other Outcomes (1)
Primary Effectiveness Endpoint
24 months
Study Arms (1)
Subjects
Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions and distributed by FX Shoulder Solutions.
Interventions
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
Eligibility Criteria
Patients who received the study devices implanted by the Investigator in accordance with the Indications for Use beginning January 1, 2018, through June 30, 2023.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
OrthoArizona
Gilbert, Arizona, 85297, United States
Advanced Orthopedics Institute
The Villages, Florida, 32159, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Brian Rogers, BS
FX Shoulder Solutions
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2023
First Posted
October 11, 2023
Study Start
December 6, 2022
Primary Completion (Estimated)
December 30, 2032
Study Completion (Estimated)
December 30, 2032
Last Updated
October 12, 2023
Record last verified: 2023-10