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

NCT07663552 | Not Yet Recruiting FDA Device

• 2 other identifiers: FX_PROTOC_CL_25-012026-A00760-51
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 4

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

Conditions

Humeral Fracture, Proximal; Revision of a Shoulder Prosthesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Revision rate (KM) at each postoperative visit

  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

  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

  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

  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

  At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)

Study Arms (4)

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

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

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

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

Interventions

Shoulder arthroplasty PROCEDURE

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

Group 1: Long Cemented HUMELOCK II® Hemi Anatomic Shoulder System for Trauma Indications; Group 2: Long Cemented HUMELOCK II® Hemi Anatomic Shoulder System for Revision Indications; Group 3: Long Cemented HUMELOCK II® Reversible Total Shoulder System for Trauma Indications; Group 4: Long Cemented HUMELOCK II® Reversible Total Shoulder System for Revision Indications

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population is issued from investigators' patient population.

You may qualify if:

• 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.

You may not qualify if:

• Neurological pathologies compromising the shoulder stability
• Morbid obesity
• Muscular deficiencies impairing the shoulder joint

Sponsors & Collaborators

• FX Solutions: lead

Study Sites (4)

CHU d' Angers

Angers, 49933, France

Location

Hôpital privé Saint-Martin

Caen, 14000, France

Location

Clinique Drouot Laffitte

Paris, 75009, France

Location

Hôpital Nord

Saint-Priest-en-Jarez, 42277, France

Location

MeSH Terms

Conditions

Shoulder Fractures

Interventions

Arthroplasty, Replacement, Shoulder

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Shoulder Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Central Study Contacts

Kathy TRIER, PhD

CONTACT

800-280-0775; ktrier@fxshouldersolutions.com

Gabriel GUEUGNON

CONTACT

+33 6 09 25 38 08

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 23, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 31, 2036
• Study Completion (Estimated): June 1, 2037
• Last Updated: June 23, 2026

Record last verified: 2026-06

Locations

FR (4)