FX Shoulder Solutions Retrospective / Prospective Clinical Study

Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions and distributed by FX Shoulder Solutions.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis Shoulder; Rotator Cuff Syndrome of Shoulder and Allied Disorders; Fracture, Shoulder
• Intervention / Treatment: Device: FX Artificial Shoulder Prosthesis

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.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Ted McKittrick, BA; Phone Number: 7242493364; Email: tmckittrick@fxshouldersolutions.com
• Study Contact Backup: Name: Brian Rogers, BS; Phone Number: 18002800775; Email: brogers@fxsholudersolutions.com

Study Locations

• United States
  • Arizona
    • Gilbert, Arizona, United States, 85297
      • Not yet recruiting
      • OrthoArizona
      • Contact: Justin Meyers; Phone Number: 480-964-2908; Email: jmyers@orthoarizona.org
      • Contact: Lauren Quarles; Phone Number: 480 284-4658; Email: lquarles@orthoarizona.org
      • Principal Investigator: William Paterson, MD
  • Florida
    • The Villages, Florida, United States, 32159
      • Recruiting
      • Advanced Orthopedics Institute
      • Contact: Kevin Trier, BS; Phone Number: 727-735-1484; Email: KTC@goaoi.com
      • Contact: Ted McKittrick; Phone Number: 7242493364; Email: tmckittrick@fxshouldersolutions.com
      • Principal Investigator: Alfred J Cook, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects; Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions and distributed 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adjusted Constant Score	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.	3, 6, 12, 24 months, 5 and 10 years.
QuickDASH	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.	3, 6, 12, 24 months, 5 and 10 years.
American Shoulder and Elbow Surgeon (ASES)	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	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.	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	ROM - 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.	3, 6, 12, 24 months, 5 and 10 years.
Device Related Adverse Events.	An adverse event that is related to the use of a device.	24 months and at 5 and 10 years postoperative
Serious Adverse Event	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	24 months and at 5 and 10 years postoperative
Number of Participants Who Have a Secondary Surgical Intervention (SSI)	SSI's are re-operations, revisions, and removals.	24 months and at 5 and 10 years
Serious Adverse Device Effects (SADE)	Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event.	24 months and at 5 and 10 years postoperative.
Number of Participants with Radiographic Reviews and Assessments.	Monitor implant integrity and signs of implant loosening	24 months, at 5 years and 10 years postoperative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Effectiveness Endpoint	The primary safety endpoint is the occurrence of any serious, device-related adverse event through 24 months of follow-up defined as an onset date before or on 730 days following the index surgery. For the primary endpoint, device-related will be defined as definite, probable, or possible relationship to the device.	24 months

Collaborators and Investigators

• Sponsor: FX Shoulder Solutions
• Investigators: Study Director: Brian Rogers, BS, FX Shoulder Solutions

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2022
• Primary Completion (Estimated): December 30, 2032
• Study Completion (Estimated): December 30, 2032

Study Registration Dates

• First Submitted: September 26, 2023
• First Submitted That Met QC Criteria: October 4, 2023
• First Posted (Actual): October 11, 2023

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Osteoarthritis; Arthroplasty; Fracture; Roartator Cuff
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Shoulder Injuries; Osteoarthritis; Shoulder Fractures
• Other Study ID Numbers: FXShoulder2022-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes