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ClinicalTrials.gov ID

NCT07663552

Lead Sponsor

FX SolutionsINDUSTRY

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

40Estimated

Last Update Posted

Jun 23, 2026Actual

Start Date

Jul 2026Estimated

Primary Completion Date

Dec 31, 2036Estimated

Completion Date

Jun 2037Estimated

Official Title

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

Brief Summary

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.

• Humeral Fracture, Proximal
• Revision of a Shoulder Prosthesis

• Shoulder arthroplasty

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Observational Model

Cohort

Time Perspective

Other

Lead Sponsor

FX SolutionsINDUSTRY

fdordain@gmail.com+33 2 31 06 02 56

dr.deranlot@gmail.com+33 6 63 55 83 40

gresta@netcourrier.com+33 6 82 79 82 89