CoCrMo LOCK bipolar hip head safety and performance after hemiarthroplasty

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a monocentric, retrospective observational study designed to assess safety and performance of CoCrMo LOCK bipolar femoral heads used in hemiarthroplasty. Patients treated from January 1, 2023 onward are followed for two years with data collected at pre-op, intra-op, discharge, and at 4, 12, and 24 months. Outcomes include revision rate, dislocation, radiographic assessments, patient-reported outcomes, and walking/residential status. The analysis will compare observed event rates to the expected performance per the device's indication for use. The goal is to confirm device safety and functional performance in real-world use after market release.

Why it matters

Who can join: the full rules

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).

Where it's running

• Splošna bolnišnica Celje
  Celje, Slovenia Recruiting

Study contacts

• Study coordinator: Monica Novello
• Email: monica.novello@enovis.com
• Phone: 3358162087

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.