CoCrMo LOCK Bipolar Femoral Heads FU

Launched by LIMACORPORATE S.P.A · Mar 17, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of a specific type of hip implant called the CoCrMo LOCK bipolar femoral head. This study will include patients who have undergone hip replacement surgery due to certain types of hip fractures or hip joint issues since January 1, 2023. To be eligible, participants must have a specific kind of hip fracture that is significantly displaced, and they should be able to walk independently before their surgery. They also need to be willing to take part in the study and have no severe cognitive issues.

While the trial is not yet recruiting participants, those who qualify can expect to share their experiences and outcomes after receiving the implant. It's important to note that certain conditions, such as minor fractures, severe arthritis, or cognitive impairments, will exclude individuals from participating. This study aims to gather valuable information that could help improve hip replacement procedures in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Displaced intracapsular hip fracture (Garden III-IV).
• • Subjects underwent a Bipolar Hemiarthroplasty with a CoCrMo LOCK Bipolar 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 CoCrMo LOCK Bipolar 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).