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Clinical trial Recruiting at 22 sites Observational Ages 18 and up

Long-term follow-up of FX Shoulder Solutions implants

Official title: RETRO-PROSPECTIVE POSTMARKET CLINICAL STUDY FOR FX SHOULDER SOLUTIONS SHOULDER SYSTEMS

Run by FX Solutions · NCT07558590 · Data updated 2026-11-12

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
Ages18 Years and up
SexAll
Enrollment1004 (estimated)
SponsorFX Solutions
Industry-sponsored
Locations22 sites (Amiens and 21 other locations)
StatusRecruiting
StartedJune 1, 2020
Main results expectedDecember 31, 2036
Study endsJune 2037
Registry record updatedApril 30, 2026
Trial IDNCT07558590 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • CHU Amiens Picardie
    Amiens, France     Recruiting
  • CHU d' Angers
    Angers, France     Recruiting
  • Hôpital Jean Minjoz
    Besançon, France     Recruiting
  • Clinique Aguiléra
    Biarritz, France     Recruiting
  • Hôpital privé Saint-Martin
    Caen, France     Recruiting
  • Infirmerie Protestante
    Caluire-et-Cuire, France     Recruiting
Show 16 more locations
  • CHMS Chambéry
    Chambéry, France     Recruiting
  • HÔPITAUX CIVILS de Colmar
    Colmar, France     Recruiting
  • Hôpital privé Dijon Bourgogne
    Dijon, France     Recruiting
  • Clinique Saint Charles
    La Roche-sur-Yon, France     Recruiting
  • Clinique chirurgicale Porte Océane
    Les Sables-d'Olonne, France     Recruiting
  • Clinique Saint Charles
    Lyon, France     Recruiting
  • L'hôpital privé du confluent
    Nantes, France     Recruiting
  • Hopital Bichat
    Paris, France     Recruiting
  • Clinique des Maussins
    Paris, France     Recruiting
  • Pavillon de la Mutualite
    Pessac, France     Recruiting
  • Clinique Saint Michel et Sainte Anne
    Quimper, France     Recruiting
  • Clinique Mutualiste
    Saint-Etienne, France     Recruiting
  • Polyclinique de l'Atlantique
    Saint-Herblain, France     Recruiting
  • C. H. St- Nazaire
    Saint-Nazaire, France     Recruiting
  • Clinique de l'Orangerie
    Strasbourg, France     Recruiting
  • Centre Hospitalier Princesse Grace
    Monaco, Monaco     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 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.