FX Shoulder Prospective Clinical Study
Study Details
Study Description
Brief Summary
Prospective Multi-Center Registry on study subjects with implanted devices marketed and legally commercialized in the USA by FX Shoulder Solutions.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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):
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Adjusted Constant Score that is ≥ 54 and improvement of ≥ 10 points from baseline Confidential FX Shoulder Post-Market Follow-Up Clinical Protocol Version 1.0 04 Aug 2022 9
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No continuous radiolucency or device migration/subsidence
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No revision surgery
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No serious device related adverse event
The Registry will continue to follow patients to 5 years post-operative to track survivorship.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Subjects Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions |
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
|
Outcome Measures
Primary Outcome 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.
- Survivorship [5 years]
Follow patient's post-operative to track survivorship.
Secondary Outcome Measures
- Adjusted Constant Score [6 weeks, 3, 6, 12, and 24 months.]
The Constant-Murley score (CMS) is a validated 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion (40 points) with the subject completing the assessment prior to the Investigator completing their part of the assessment. The higher the score, the higher the quality of the function. An Adjusted Constant score will be calculated using normalized values to account for age and gender, as based upon anatomical gender at birth.
- QuickDASH [6 weeks, 3, 6, 12, and 24 months.]
QuickDASH measures an individual's ability to complete tasks, absorb forces, and severity of symptoms. The QuickDASH tool uses a 5-point Likert scale from which the patient can select an appropriate number corresponding to his/her severity level/ function level. The higher the score, the higher the function and lower pain in the patient.
- American Shoulder and Elbow Surgeon (ASES) [6 weeks, 3, 6, 12, and 24 months]
ASES is a validated patient-reported outcome which is composed of 10 functional questions and one pain VAS. The total score is of 100 maximum points and weighted evenly between pain and function
- Visual Analog Scale (VAS). [6 weeks, 3, 6, 12, and 24 months]
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.
- Range of Motion (ROM) [6 weeks, 3, 6, 12, and 24 months]
The patient performs active movements in all functional planes for the shoulder. Includes flexion, extension, abduction, adduction and internal and external rotation. Investigator estimates the range of movement and compares the affected with the unaffected shoulder and the normal expected range.
- Secondary Surgical Interventions (SSI) [24 months and at 5 years postoperative]
SSI's are re-operations, revisions, and removals.
- Serious Adverse Event [24 months and at 5 years postoperative]
Led to a death. Resulted in life threatening illness or injury. Resulted in patient hospitalization or prolongation of existing hospitalization. Resulted in patient disability or permanent damage or required intervention to prevent permanent impairment/damage. Led to a congenital abnormality or birth defect.
- Serious Adverse Device Effects (SADE) [24 months and at 5 years postoperative.]
Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event.
- Radiographic Reviews and Assessments. [24 months and at 5 years postoperative.]
Monitor implant integrity and signs of implant loosening.
- Survival [24 months and at 5 years]
Subject disposition.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | OrthoArizona | Gilbert | Arizona | United States | 85297 |
| 2 | First Settlement Orthopedics | Marietta | Ohio | United States | 45750 |
| 3 | Orthopedics Rhode Island | Wakefield | Rhode Island | United States | 02879 |
| 4 | Texas Orthopedic Specialists | Bedford | Texas | United States | 76021 |
Sponsors and Collaborators
- FX Shoulder Solutions
Investigators
- Study Director: Brian Rogers, BS, FX Shoulder Solutions
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FXShoulder2020-01
- FXShoulder2020-1