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Not yet recruiting NCT07663552

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

— Observational Humeral Fracture, Proximal Revision of a Shoulder Prosthesis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Shoulder arthroplasty.
Who it may be relevant to
Registry conditions: Humeral Fracture, Proximal, Revision of a Shoulder Prosthesis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Detailed description

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.

Interventions

  • Procedure Shoulder arthroplasty
    Hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.

Primary outcome measures

  • Revision rate (KM) at 10 years postoperative [Time frame: at the end of the postoperative follow-up period of 10 years]
Secondary outcome measures (7)
  • 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)]
  • 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)]
  • 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)]
  • 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)]
  • 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)]
  • 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)]
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 4 centers
  • CHU d' Angers — Angers
  • Hôpital privé Saint-Martin — Caen
  • Clinique Drouot Laffitte — Paris
  • Hôpital Nord — Saint-Priest-en-Jarez

Identifiers

NCT: NCT07663552 · FX_PROTOC_CL_25-01 · 2026-A00760-51

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗