Clinical trial NCT06078865: FX Shoulder Prospective Clinical Study
Official title: FX Shoulder Post-Market Follow-Up Clinical Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoarthritis Shoulder
Rotator Cuff Syndrome of Shoulder and Allied Disorders
Fracture, Shoulder
Keywords: Osteoarthritis
Roartator Cuff
Fracture
Lead sponsor: FX Shoulder Solutions
Sponsor class: INDUSTRY
First posted: 2023-10-12
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief summary: Prospective Multi-Center Registry on study subjects with implanted devices marketed and legally commercialized in the USA by FX Shoulder Solutions.

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.

Eligibility 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.

Primary outcomes:
measure: A patient is considered a success at post-operative follow-up based upon the following composite clinical success (CCS):
timeFrame: 2 years
measure: Survivorship
timeFrame: 5 years
Secondary outcomes:
measure: Adjusted Constant Score
timeFrame: 6 weeks, 3, 6, 12, and 24 months.
measure: QuickDASH
timeFrame: 6 weeks, 3, 6, 12, and 24 months.
measure: American Shoulder and Elbow Surgeon (ASES)
timeFrame: 6 weeks, 3, 6, 12, and 24 months
measure: Visual Analog Scale (VAS).
timeFrame: 6 weeks, 3, 6, 12, and 24 months
measure: Range of Motion (ROM)
timeFrame: 6 weeks, 3, 6, 12, and 24 months
measure: Secondary Surgical Interventions (SSI)
timeFrame: 24 months and at 5 years postoperative
measure: Serious Adverse Event
timeFrame: 24 months and at 5 years postoperative
measure: Serious Adverse Device Effects (SADE)
timeFrame: 24 months and at 5 years postoperative.
measure: Radiographic Reviews and Assessments.
timeFrame: 24 months and at 5 years postoperative.
measure: Survival
timeFrame: 24 months and at 5 years
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: OrthoArizona
state: Arizona
city: Marietta
country: United States
facility: First Settlement Orthopedics
state: Ohio
city: Wakefield
country: United States
facility: Orthopedics Rhode Island
state: Rhode Island
city: Bedford
country: United States
facility: Texas Orthopedic Specialists
state: Texas
Study officials:
affiliation: FX Shoulder Solutions
name: Brian Rogers, BS
role: STUDY_DIRECTOR
References: