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

Study Overview

• Status: Not yet recruiting
• Conditions: Humeral Fracture, Proximal; Revision of a Shoulder Prosthesis
• Intervention / Treatment: Procedure: Shoulder arthroplasty

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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Kathy TRIER, PhD; Phone Number: 800-280-0775; Email: ktrier@fxshouldersolutions.com
• Study Contact Backup: Name: Gabriel GUEUGNON; Phone Number: +33 6 09 25 38 08

Study Locations

• France
  • Angers, France, 49933
    • CHU d' Angers
    • Contact: Romain LANCIGU, MD; Phone Number: +33 6 07 02 11 34; Email: romain.lancigu@gmail.com
  • Caen, France, 14000
    • Hôpital privé Saint-Martin
    • Contact: Franck DORDAIN, MD; Phone Number: +33 2 31 06 02 56; Email: fdordain@gmail.com
  • Paris, France, 75009
    • Clinique Drouot Laffitte
    • Contact: Jules DERANLOT, MD; Phone Number: +33 6 63 55 83 40; Email: dr.deranlot@gmail.com
  • Saint-Priest-en-Jarez, France, 42277
    • Hôpital Nord
    • Contact: Giorgio GRESTA, MD; Phone Number: +33 6 82 79 82 89; Email: gresta@netcourrier.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Study population is issued from investigators' patient population.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1: Long Cemented HUMELOCK II® Hemi Anatomic Shoulder System for Trauma Indications; Subjects treated with cemented long HUMELOCK II® Hemi Anatomic Shoulder System for traumatic indications	Procedure: Shoulder arthroplasty; Hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.
Group 2: Long Cemented HUMELOCK II® Hemi Anatomic Shoulder System for Revision Indications; Subjects treated with cemented long HUMELOCK II® Hemi Anatomic Shoulder System for revision indications	Procedure: Shoulder arthroplasty; Hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.
Group 3: Long Cemented HUMELOCK II® Reversible Total Shoulder System for Trauma Indications; Subjects treated with cemented long HUMELOCK II® Reversible Shoulder System for traumatic indications	Procedure: Shoulder arthroplasty; Hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.
Group 4: Long Cemented HUMELOCK II® Reversible Total Shoulder System for Revision Indications; Subjects treated with cemented long HUMELOCK II® Reversible Shoulder System for revision indications	Procedure: Shoulder arthroplasty; Hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revision rate (KM) at 10 years postoperative	Survival rate (%) at 10 years calculated by means of Kaplan-Meier method	at the end of the postoperative follow-up period of 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of Motions at each postoperative visit		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		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		At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
Revision rate (KM) at each postoperative visit	Survival rate (%) at each postoperative visit calculated by means of Kaplan-Meier method	At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years)
Constant-Murley score at each postopererative visit	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.	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	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.	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	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').	At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)

Collaborators and Investigators

• Sponsor: FX Solutions

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2036
• Study Completion (Estimated): June 1, 2037

Study Registration Dates

• First Submitted: June 17, 2026
• First Submitted That Met QC Criteria: June 17, 2026
• First Posted (Actual): June 23, 2026

Study Record Updates

• Last Update Posted (Actual): June 23, 2026
• Last Update Submitted That Met QC Criteria: June 17, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Fractures, Bone; Shoulder Fractures; Surgical Procedures, Operative; Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Plastic Surgery Procedures; Prosthesis Implantation; Arthroplasty, Replacement, Shoulder
• Other Study ID Numbers: FX_PROTOC_CL_25-01; 2026-A00760-51 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No