Cephalic Femoral Heads Follow Up

NCT06873568 | Not Yet Recruiting

• 1 other identifier: H-45
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Arthroplasty Replacement; Femoral Fractures

Keywords

femoral head; Partial hip arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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.

  12 months follow up visit

• Assessment of Harris Hip Score (HHS) at 24 months after Unipolar Hemiarthroplasty with Cephalic femoral heads.

  24 months follow up visit

• Assessment of Oxford Hip Score (OHS) completed by subjects with Cephalic femoral heads at 24 months after Unipolar Hemiarthroplasty.

  24 months follow up visit

Study Arms (1)

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.

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Limacorporate S.p.a: lead

Study Sites (1)

University Hospital J.A. Reimana

Prešov, 5898, Slovakia

Location

MeSH Terms

Conditions

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Central Study Contacts

Monica Novello

CONTACT

+39 3358162087; monica.novello@enovis.com

Francesca Citossi

CONTACT

+39 0432 945511; clinicalresearch@enovis.com

Study Design

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

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 12, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 18, 2025

Record last verified: 2025-03

Locations

SL (1)