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NCT Number: NCT07558590

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

This study takes place in the framework of the PostMarket Clinical Follow-up plan of the Shoulder Systems commercialized by FX SHOULDER SOLUTIONS.

The included cases will be followed for 10 years after index surgery. Primary objective is the assessment in real life of the revision rate of the shoulder systems at long-term.

Secondary objectives are

* Revision rate at each post op visit * Range of motion at each post op visit * Quick Dash, Constant, American Shoulder and Elbow Surgeons Shoulder Score (ASES), Subjective Shoulder Value (SSV), Pain scores at each post op visit * Radiological assessment of implant positioning through geometrical parameters at each post op visit * Incidence of complications at each post op visit * Qualitative feedback from surgeons on the instrumentation

Recruiting

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Key information

Conditions

Humeral Fracture, Proximal Arthritis Avascular Necrosis of the Head of Humerus Fractures, Bone Glenohumeral Osteoarthritis Inflammatory Arthritis Joint Diseases Musculoskeletal Diseases Revision of a Shoulder Prosthesis Rotator Cuff Arthropathy Rotator Cuff Injuries Rotator Cuff Tear Rupture Shoulder Fractures Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens Picardie, Amiens, France

Loading trial locations.

About this study

1004 cases are planned to be included in 11 groups of implants (range, indication and constructs).

Recruitment of patients can be retrospective or prospective, preferrably prospective.

Prospective follow-up of the patients after inclusion at 6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years , 7 years and 10 years postoperatively.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shoulder Arthroplasty

Procedure

Total anatomical (TSA), hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.

Primary outcomes

  1. Revision rate (KM) at 10 years postoperative

    Time frame: at the end of the postoperative follow-up period of 10 years

Secondary outcomes

  1. Revision rate (KM) at each post-operative visits

    Time frame: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years)

  2. Range of Motions at each postoperative visit

    Time frame: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)

  3. QuickDASH score at each follow-up visit

    Time frame: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)

  4. Constant-Murley score at each follow-up visit

    Time frame: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)

  5. ASES score at each postoperative visit

    Time frame: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)

  6. VAS pain at each postoperative visit

    Time frame: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)

  7. SSV score at each postoperative visit

    Time frame: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)

  8. Radiological assessment of implant positioning at each postoperative visit

    Time frame: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)

  9. Incidence of complications at each postoperative visit

    Time frame: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)

  10. Qualitative feedback on the instrumentation

    Time frame: at surgery reporting

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriel GUEUGNON

CONTACT

[email protected]

Kathy TRIER, PhD

CONTACT

[email protected]

800-280-0775

Sponsors and collaborators

Lead sponsor

FX Solutions

Industry

Registry information

Important dates

Study start
2020
Primary completion
2036
Study completion
2037
First posted
Apr 30, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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