Cephalic Femoral Heads Follow Up

Launched by LIMACORPORATE S.P.A · Mar 11, 2025

Keywords

ClinConnect Summary

The Cephalic Femoral Heads Follow Up clinical trial is studying the safety and effectiveness of a specific type of hip implant called cephalic femoral heads. This trial is for people who have had a hip replacement surgery due to a certain type of hip fracture known as a displaced intracapsular hip fracture. If you are between the ages of 65 and 74, have had this type of surgery since January 1, 2023, and can walk independently, you might be eligible to participate.

During the trial, participants will be monitored to see how well the implants work and if they are safe for use. It’s important to note that people with certain conditions, such as less severe fractures or severe arthritis, and those who cannot walk before surgery, will not be included in the study. If you decide to participate, you will be contributing valuable information that could help improve future hip surgeries for others. The study is not yet recruiting participants but will focus on those who meet the criteria and are willing to take part in this important research.

Gender

ALL

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).