CoCrMo LOCK Bipolar Femoral Heads FU
Trial statusRecruiting
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 CoCrMo LOCK bipolar femoral heads. The eligible study population is represented by the entire population that underwent a hip replacement with CoCrMo LOCK bipolar 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 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.
Disqualifiers
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.
Trial population
Patients who underwent partial hip arthroplasty with CoCrMo LOCK bipolar femoral heads from 1st January 2023 onwards
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 1 trial groupGroup A: CoCrMo LOCK bipolar femoral head implanted patient
Trial outcomes
Primary outcomes
1
Evaluation of the revision rate of CoCrMo LOCK Bipolar femoral heads at 24 months after surgery.
Time frame
At 24 months after intraoperative visitSecondary outcomes
1
Evaluation of the dislocation rate (including close reduction) in subjects with CoCrMo LOCK Bipolar femoral heads at 24 months after bipolar hemiarthroplasty
Time frame
At 24 months after intraoperative visit2
Evaluation of the revision incidence of any hip component for any reason at 24 months after bipolar hemiarthroplasty.
Time frame
At 24 months after intraoperative visit3
Evaluation of acetabular erosion (according to Baker classification) in subjects with CoCrMo LOCK Bipolar femoral heads at 12 months after Bipolar Hemiarthroplasty.
Time frame
At 12 months after intraoperative visit4
Assessment of Harris Hip Score (HHS) at 24 months after Bipolar Hemiarthroplasty with CoCrMo LOCK Bipolar femoral heads.
The Harris Hip Score goes from 0 to 100, which is the best result.
Time frame
At 24 months after intraoperative visitSponsors and contacts
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Source ClinicalTrials.gov