Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07663552

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

Sponsor: FX Solutions

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

40

Start Date

2026-07

Completion Date

2037-06

Last Updated

2026-06-23

Healthy Volunteers

No

Interventions

PROCEDURE

Shoulder arthroplasty

Hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.

Locations (4)

CHU d' Angers

Angers, France

Hôpital privé Saint-Martin

Caen, France

Clinique Drouot Laffitte

Paris, France

Hôpital Nord

Saint-Priest-en-Jarez, France