FX Shoulder Prospective Clinical Study

FX Shoulder Post-Market Follow-Up Clinical Study

Prospective Multi-Center Registry on study subjects with implanted devices marketed and legally commercialized in the USA 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 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 Confidential FX Shoulder Post-Market Follow-Up Clinical Protocol Version 1.0 04 Aug 2022 9
• No continuous radiolucency or device migration/subsidence
• No revision surgery
• No serious device related adverse event

The Registry will continue to follow patients to 5 years post-operative to track survivorship.

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

Contacts and Locations

• Study Contact: Name: Ted McKittrick, BA; Phone Number: 724 249-3364; Email: tmckittrick@fxshouldersolutions.com
• Study Contact Backup: Name: Brian Rogers, BS; Phone Number: 1800 280-0775; Email: brogers@fxsholudersolutions.com

Study Locations

• United States
  • Arizona
    • Gilbert, Arizona, United States, 85297
      • Recruiting
      • OrthoArizona
      • Contact: Lauren Quarles; Phone Number: 480 284-4658; Email: lquarles@orthoarizona.org
      • Principal Investigator: William Paterson, MD
      • Contact: Justin Meyers; Phone Number: 480-284-4658; Email: jmyers@orthoarizona.org
  • Ohio
    • Marietta, Ohio, United States, 45750
      • Recruiting
      • First Settlement Orthopedics
      • Principal Investigator: John Henry, MD
      • Contact: Angie Miller, FNP-BC; Phone Number: 740-373-8456; Email: angie_d_miller@yahoo.com
      • Contact: Joette Fetty, CPC; Phone Number: 142 740 373-8756; Email: joefetty@mhsystem.org
  • Rhode Island
    • Wakefield, Rhode Island, United States, 02879
      • Recruiting
      • Orthopedics Rhode Island
      • Principal Investigator: Michael Bradley, MD
      • Contact: Jennifer Stedman; Phone Number: 2322 401-777-7000; Email: jstedman@orthopedicsri.com]
  • Texas
    • Bedford, Texas, United States, 76021
      • Recruiting
      • Texas Orthopedic Specialists
      • Contact: Amber Morgan; Phone Number: 817-510-4022; Email: amber@txortho.net
      • Principal Investigator: Howard Harris, MD

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

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	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
A patient is considered a success at 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.	2 years
Survivorship	Follow patient's post-operative to track survivorship.	5 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.	6 weeks, 3, 6, 12, and 24 months.
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.	6 weeks, 3, 6, 12, and 24 months.
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	6 weeks, 3, 6, 12, and 24 months
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.	6 weeks, 3, 6, 12, and 24 months
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.	6 weeks, 3, 6, 12, and 24 months
Secondary Surgical Interventions (SSI)	SSI's are re-operations, revisions, and removals.	24 months and at 5 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 years postoperative
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 years postoperative.
Radiographic Reviews and Assessments.	Monitor implant integrity and signs of implant loosening.	24 months and at 5 years postoperative.
Survival	Subject disposition.	24 months and at 5 years

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): March 31, 2021
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: September 26, 2023
• First Submitted That Met QC Criteria: October 5, 2023
• First Posted (Actual): October 12, 2023

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Osteoarthritis; 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: FXShoulder2020-01; FXShoulder2020-1 (Other Identifier: FX Shoulder Solutions)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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.: No