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Cephalic Femoral Heads Follow Up | Clinical Trials | Clareo Health

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Not Yet RecruitingNCT06873568

Cephalic Femoral Heads Follow Up

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 ...

Lead sponsor: Limacorporate S.p.a•1 locations•View source on ClinicalTrials.gov

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Contacts

Monica Novello

CONTACT

+39 3358162087 [email protected]

Francesca Citossi

CONTACT

+39 0432 945511 [email protected]

Sponsors

Lead Sponsor

Limacorporate S.p.a

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).

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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).

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 18, 2025Terms

Trial snapshot

StatusNOT_YET_RECRUITING

Phase—

Enrollment47

Start dateOct 2025

Last updatedMar 18, 2025

Condition

Hip Arthroplasty Replacement Femoral Fractures

Locations shown

University Hospital J.A. Reimana

Prešov

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2025Data synced to Clareo: July 13, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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