Cephalic Femoral Heads Follow Up

NCT ID: NCT06873568

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 47 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2027-12-31

Brief Summary

Study design: monocentric, retrospective, observational and post-market clinical study.

Purpose: To demonstrate the safety and performance of cephalic femoral heads. The eligible study population is represented by the entire population that underwent a hip replacement with cephalic femoral heads from 1st January 2023 onwards at the site in accordance with the indication for use of the product.

Detailed Description

The study is aiming to demoranstrate safety and performance of cephalic femoral heads and will do it by considering the rate of revision of any prosthesis component and dislocation, by x-ray evaluation, by patient reported outcomes and walking/residential status. Patients are followed for 2 years after hemiarthroplasty and data are collected at 6 timepoints (pre-operative, intra-operative, at discharge, 4-months follow up, 12 months follow up and 24 months follow up).

Conditions

Hip Arthroplasty Replacement; Femoral Fractures

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients who underwent hip arthroplasty with cephalic femoral heads from 1at January 2023 onwards.

The study population for this clinical investigation includes subjects who suffered from a traumatic proximal femur fracture and underwent a Unipolar hemiarthroplasty with Cephalic femoral head from January 1st, 2023, onwards. Due to the characteristics of patients who underwent this type of surgery, it is expected that a considerable number of eligible patients would be in the elderly age.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Displaced intracapsular hip fracture (Garden III-IV).
• Subjects underwent a Unipolar Hemiarthroplasty with a Cephalic femoral head as per their Indication For Use from January 1st, 2023, onwards.
• No concurrent joint disease at the time of the surgery.
• Absence of severe cognitive dysfunction demonstrated by 3 or more correct answers on the Pfeiffer test.
• Ability to ambulate independently with or without walking aids before surgery.
• Subject willingness to participate.

Exclusion Criteria

• Undisplaced or minimally displaced intracapsular hip fracture (Garden I-II).
• Any Cephalic femoral head contraindication for use as reported in the current Instruction For Use.
• Pathological fracture secondary to malignant disease.
• Subjects with rheumatoid arthritis or symptomatic osteoarthritis.
• Previous treatment to the same hip for a fracture at the time of the surgery.
• Subjects who were deemed unsuitable for the surgical procedures by the anesthesiologist.
• Severe cognitive dysfunction or cognitive impairment demonstrated by 2 or less correct answers on the Pfeiffer test.
• Unable to walk before surgery (e.g., wheelchair or bed-ridden subjects).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Limacorporate S.p.a

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital J.A. Reimana

Prešov, , Slovakia

Countries

Slovakia

Central Contacts

Monica Novello

Role: CONTACT

monica.novello@enovis.com

+39 3358162087

Francesca Citossi

Role: CONTACT

clinicalresearch@enovis.com

+39 0432 945511

Facility Contacts

Dominik Kobak

Role: primary

kobakd@fnsppresov.sk

051/701 1899

Other Identifiers

H-45

Identifier Type: -

Identifier Source: org_study_id