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Long-term follow-up of FX Shoulder Solutions implants

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

Observational FX Solutions · NCT07558590

This follow-up will track adults who receive FX Shoulder Solutions hemi or total shoulder replacements to see if the implants need revision and how well shoulder function and pain hold up over 10 years.

Quick facts

Study typeObservational
Enrollment1004 (estimated)
Ages18 Years and up
SexAll
SponsorFX Solutions Industry-sponsored
Locations22 sites (Amiens and 21 other locations)
Trial IDNCT07558590 on ClinicalTrials.gov

What this trial studies

This post‑market program enrolls up to 1,004 cases across 11 implant groups and follows patients for 10 years after their index shoulder arthroplasty. Enrollment may be retrospective or preferably prospective, with follow-up visits at 6 weeks, 3–6 months, 1, 2, 3, 5, 7 and 10 years. The primary outcome is long‑term revision rate, and secondary outcomes include range of motion, patient‑reported scores (QuickDASH, Constant, ASES, SSV, pain), radiographic implant positioning, complication incidence, and qualitative surgeon feedback on instrumentation. Data collection is intended to reflect real‑world performance of the FX Shoulder Solutions systems.

Who should consider this trial

Good fit: Adults aged 18 and over who are insured, have provided informed consent, and are indicated for hemi or total shoulder replacement with an FX Shoulder Solutions system per the device instructions are eligible.

Not a fit: Patients with neurological disorders that compromise shoulder stability, morbid obesity, or severe muscular deficiencies impairing the shoulder joint are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the results could confirm the implants' long‑term durability and safety and help surgeons choose the best replacement for patients.

How similar studies have performed: Long‑term postmarket registries and cohort studies of shoulder arthroplasty have previously produced useful revision and function data, so this approach follows established methods rather than being entirely novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Indication for hemi or total shoulder replacement with one of the FX SHOULDER SOLUTIONS Shoulder Systems, according to its IFU and surgical technique.
* Patient aged 18 years and above
* Patient insured with a social security system
* Has been informed and did consent to participate to the study.

Exclusion Criteria:

* Neurological pathologies compromising the shoulder stability
* Morbid obesity
* Muscular deficiencies impairing the shoulder joint

Where this trial is running

Amiens and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
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Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.