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NCT Number: NCT07663552

Retro-Prospective Postmarket Clinical Study For FX Shoulder Solutions Long Cemented HUMELOCK II®

This study takes place in the framework of the PostMarket Clinical Follow-up plan of the HUMELOCK II(r) long cemented humeral stem (shoulder prosthesis) 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 * Constant Score, American Shoulder and Elbow Surgeons Shoulder Score (ASES), Pain score (VAS) 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

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Key information

Conditions

Humeral Fracture, Proximal Fractures, Bone Revision of a Shoulder Prosthesis Shoulder Fractures Shoulder Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU d' Angers, Angers, France

Loading trial locations.

About this study

Recruitment of patients can be retrospective or prospective, mainly retrospectively. Follow-up will be prospective from the date of study inception.

Recruitment will include all cases available at the selected investigation centers.

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 anatomic or total reversible shoulder replacement with Long Cemented HUMELOCK II® humeral stem for Trauma or Revision indication, 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

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

    Survival rate (%) at 10 years calculated by means of Kaplan-Meier method

Secondary outcomes

  1. Revision rate (KM) 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)

    Survival rate (%) at each postoperative visit calculated by means of Kaplan-Meier method

  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. Constant-Murley score at each postopererative 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)

    The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The higher the score, the higher the quality of the function and the lower the pain is.

  4. 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)

    ASES (American Shoulder and Elbow Surgeons) score ranges from 0 to 100, with 0 the lowest level of function and 100 the highest level of function.

  5. 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)

    The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').

  6. 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)

  7. 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)

Study contacts

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

Gabriel GUEUGNON

CONTACT

+33 6 09 25 38 08

Kathy TRIER, PhD

CONTACT

[email protected]

800-280-0775

Sponsors and collaborators

Lead sponsor

FX Solutions

Industry

Registry information

Important dates

Study start
2026
Primary completion
2036
Study completion
2037
First posted
Jun 23, 2026
Registry last updated
Jun 23, 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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