Cephalic Femoral Heads Follow Up

A Post-market Study Evaluating Clinical and Safety Outcomes of Unipolar Hemiarthroplasty Using Cephalic Femoral Heads in Subjects with Hip Fracture

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Femoral Fractures; Hip Arthroplasty Replacement

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).

• Study Type: Observational
• Enrollment (Estimated): 47

Contacts and Locations

• Study Contact: Name: Monica Novello; Phone Number: +39 3358162087; Email: monica.novello@enovis.com
• Study Contact Backup: Name: Francesca Citossi; Phone Number: +39 0432 945511; Email: clinicalresearch@enovis.com

Study Locations

• Slovakia
  • Presov, Slovakia, 5898
    • University Hospital J.A. Reimana
    • Contact: Dominik Kobak; Phone Number: 051/701 1899; Email: kobakd@fnsppresov.sk

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

Patients who underwent partial hip arthroplasty with cephalic femoral heads from 1st January 2023 onwards

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of the revision rate of Cephalic femoral heads for any reason at 24 months after Unipolar Hemiarthroplasty.	From intraoperative to 24months follow up visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the dislocation rate (including close reduction) in subjects with Cephalic femoral heads from intra-operative to 24 months after Unipolar Hemiarthroplasty.		From intraoperative to 24months follow up visit
Evaluation of the revision incidence of any hip component for any reason from intra-operative to 24 months after Unipolar Hemiarthroplasty.		From intraoperative to 24months follow up visit
Evaluation of acetabular erosion (according to Baker classification) in subjects with Cephalic femoral heads at 12 months after Unipolar Hemiarthroplasty.	Baker classification is graded from 0 to 3, where 3 is the worst case. Grade 0: no erosion Grade 1: narrowing the arthicular cartilage, no erosion Grade 2: acetabular erosion and early migration Grade 3: protrusion acetabuli	12 months follow up visit
Assessment of Harris Hip Score (HHS) at 24 months after Unipolar Hemiarthroplasty with Cephalic femoral heads.	The Harris Hip Score goes from 0 to 100, which is the best result.	24 months follow up visit
Assessment of Oxford Hip Score (OHS) completed by subjects with Cephalic femoral heads at 24 months after Unipolar Hemiarthroplasty.	The Oxford Hip Score goes from 0 to 48, with 48 being the best outcome	24 months follow up visit
Assessment of Pain Likert-scale in subjects with Cephalic femoral heads at 24 months after Unipolar Hemiarthroplasty.	The pain Likert-scale is a 6-point scale: severe and spontaneous; severe when walking; tollerable; occurs after activity; light intermittent; no pain	24 months follow up visit
Comparison between pre-operative and 4-month walking ability.	Functional evaluation	Performed at preoperative visit to 4months follow up visit
Comparison between pre-operative and 4-month residential status.	Daily habit	Performed at preoperative visit and 4months follow up visit

Collaborators and Investigators

• Sponsor: Limacorporate S.p.a

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 7, 2025
• First Submitted That Met QC Criteria: March 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: femoral head; Partial hip arthroplasty
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Femoral Fractures
• Other Study ID Numbers: H-45

Drug and device information, study documents

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