Retro-Prospective Postmarket Clinical Study for FX Shoulder Solutions Shoulder Systems Evaluating Long-Term Outcomes

What this Trial Is About

Researchers are evaluating the long-term outcomes of various shoulder replacement systems sold by FX SHOULDER SOLUTIONS. This observational study follows patients who have undergone shoulder arthroplasty, including total anatomical, hemi anatomical, or reversed procedures. The main goal is to measure the rate of revision surgeries over a 10-year period after the initial operation. Secondary goals include assessing shoulder movement, pain, function scores, implant positioning, complications, and surgeon feedback throughout follow-up visits. The study plans to include 1004 patients treated with one of 11 different shoulder implant types, covering a range of indications such as trauma, degenerative conditions, and revisions. Patients may be enrolled retrospectively or prospectively, with a preference for prospective recruitment. Participants are followed at scheduled intervals after surgery: 6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, and finally 10 years post-operation. During the study, patients will attend regular postoperative visits where their shoulder function is evaluated using standardized scores like QuickDASH, Constant-Murley, ASES, and Subjective Shoulder Value. Pain levels and radiological assessments of implant positioning are also performed at each visit. Researchers will monitor for any complications and collect qualitative feedback on the surgical instruments used. The study offers long-term monitoring of shoulder implant performance in real-life conditions over a decade.

RETRO-PROSPECTIVE POSTMARKET CLINICAL STUDY FOR FX SHOULDER SOLUTIONS SHOULDER SYSTEMS