Cephalic Femoral Heads Follow Up
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLimacorporate S.p.a
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
47 Participants
are grouped into 1 trial groupSponsors and collaborators
Source ClinicalTrials.gov