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NCT06873568 | NOT YET RECRUITING | Hip Arthroplasty Replacement

Cephalic Femoral Heads Follow Up
Sponsor:

Limacorporate S.p.a

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.

Condition or disease

Hip Arthroplasty Replacement

Femoral Fractures

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
Estimated Enrollment : 47 participants
Official Title : A Post-market Study Evaluating Clinical and Safety Outcomes of Unipolar Hemiarthroplasty Using Cephalic Femoral Heads in Subjects with Hip Fracture
Actual Study Start Date : 2025-10
Estimated Primary Completion Date : 2027-12
Estimated Study Completion Date : 2027-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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).
Cephalic Femoral Heads Follow Up

Location Details

NCT06873568

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Slovakia,

University Hospital J.A. Reimana

Obes, Slovakia, 5898