Clinical trial NCT06077942: FX Shoulder Solutions Retrospective / Prospective Clinical Study
Official title: FX Shoulder Solutions Retrospective / Prospective Clinical Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rotator Cuff Syndrome of Shoulder and Allied Disorders
Osteoarthritis Shoulder
Fracture, Shoulder
Keywords: Osteoarthritis
Roartator Cuff
Fracture
Arthroplasty
Lead sponsor: FX Shoulder Solutions
Sponsor class: INDUSTRY
First posted: 2023-10-11
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 10 years
Secondary outcomes:
measure: Adjusted Constant Score
timeFrame: 3, 6, 12, 24 months, 5 and 10 years.
measure: QuickDASH
timeFrame: 3, 6, 12, 24 months, 5 and 10 years.
measure: American Shoulder and Elbow Surgeon (ASES)
timeFrame: 3, 6, 12, 24 months, 5 and 10 years.
measure: 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.
timeFrame: 3, 6, 12, 24 months, 5 and 10 years
measure: Range of Motion
timeFrame: 3, 6, 12, 24 months, 5 and 10 years.
measure: Number of Participants Who Have a Secondary Surgical Intervention (SSI)
timeFrame: 24 months and at 5 and 10 years
measure: Device Related Adverse Events.
timeFrame: 24 months and at 5 and 10 years postoperative
measure: Serious Adverse Event
timeFrame: 24 months and at 5 and 10 years postoperative
measure: Serious Adverse Device Effects (SADE)
timeFrame: 24 months and at 5 and 10 years postoperative.
measure: Number of Participants with Radiographic Reviews and Assessments.
timeFrame: 24 months, at 5 years and 10 years postoperative
Other outcomes:
measure: Primary Effectiveness Endpoint
timeFrame: 24 months
Locations:
city: Gilbert
country: United States
facility: OrthoArizona
state: Arizona
city: The Villages
country: United States
facility: Advanced Orthopedics Institute
state: Florida
Study officials:
affiliation: FX Shoulder Solutions
name: Brian Rogers, BS
role: STUDY_DIRECTOR
References: