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
This trial does not accept healthy volunteersQualifiers
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 population
Patients who underwent partial hip arthroplasty with cephalic femoral heads from 1st January 2023 onwards
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
47 Participants
are grouped into 1 trial groupGroup A: Patients who underwent hip arthroplasty with cephalic femoral heads from 1at January 2023 onwards.
Trial outcomes
Primary outcomes
1
Evaluation of the revision rate of Cephalic femoral heads for any reason at 24 months after Unipolar Hemiarthroplasty.
Time frame
From intraoperative to 24months follow up visitSecondary outcomes
1
Evaluation of the dislocation rate (including close reduction) in subjects with Cephalic femoral heads from intra-operative to 24 months after Unipolar Hemiarthroplasty.
Time frame
From intraoperative to 24months follow up visit2
Evaluation of the revision incidence of any hip component for any reason from intra-operative to 24 months after Unipolar Hemiarthroplasty.
Time frame
From intraoperative to 24months follow up visit3
Evaluation of acetabular erosion (according to Baker classification) in subjects with Cephalic femoral heads at 12 months after Unipolar Hemiarthroplasty.
Baker classification is graded from 0 to 3, where 3 is the worst case. Grade 0: no erosion Grade 1: narrowing the arthicular cartilage, no erosion Grade 2: acetabular erosion and early migration Grade 3: protrusion acetabuli
Time frame
12 months follow up visit4
Assessment of Harris Hip Score (HHS) at 24 months after Unipolar Hemiarthroplasty with Cephalic femoral heads.
The Harris Hip Score goes from 0 to 100, which is the best result.
Time frame
24 months follow up visitSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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