RecruitingNot Applicable

FX Shoulder Solutions Retrospective / Prospective Clinical Study

United States600 participantsStarted 2022-12-06

Plain-language summary

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

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Trial details

NCT IDNCT06077942

SponsorFX Shoulder Solutions

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2032-12-30

Contact for this trial

Ted McKittrick, BA

7242493364 tmckittrick@fxshouldersolutions.com

View on ClinicalTrials.gov More Rotator Cuff Syndrome of Shoulder and Allied Disorders trials