Clinical trial NCT06885359: CoCrMo LOCK Bipolar Femoral Heads FU
Official title: A Post-market Study Evaluating Clinical and Safety Outcomes of Bipolar Hemiarthroplasty Using CoCrMo LOCK Bipolar Femoral Heads in Subjects with Hip Fracture
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Femoral Fractures
Hip Arthropathy
Keywords: Femoral head
Partial Hip Arthroplasty
Lead sponsor: Limacorporate S.p.a
Sponsor class: INDUSTRY
First posted: 2025-03-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent partial hip arthroplasty with CoCrMo LOCK bipolar femoral heads from 1st January 2023 onwards

Brief summary: 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.

Detailed description: The study is aiming to demoranstrate safety and performance of LOCK Bipolar femoral heads and will do it by considering the rate of revision of any prosthesis component and dislocation, by x-ray evaluation, by patient reported outcomes and walking/residential status. Patients are followed for 2 years after hemiarthroplasty and data are collected at 6 timepoints (pre-operative, intra-operative, at discharge, 4-months follow up, 12 months follow up and 24 months follow up).

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).

Primary outcomes:
measure: Evaluation of the revision rate of CoCrMo LOCK Bipolar femoral heads at 24 months after surgery.
timeFrame: At 24 months after intraoperative visit
Secondary outcomes:
measure: Evaluation of the dislocation rate (including close reduction) in subjects with CoCrMo LOCK Bipolar femoral heads at 24 months after bipolar hemiarthroplasty
timeFrame: At 24 months after intraoperative visit
measure: Evaluation of the revision incidence of any hip component for any reason at 24 months after bipolar hemiarthroplasty.
timeFrame: At 24 months after intraoperative visit
measure: Evaluation of acetabular erosion (according to Baker classification) in subjects with CoCrMo LOCK Bipolar femoral heads at 12 months after Bipolar Hemiarthroplasty.
timeFrame: At 12 months after intraoperative visit
measure: Assessment of Harris Hip Score (HHS) at 24 months after Bipolar Hemiarthroplasty with CoCrMo LOCK Bipolar femoral heads.
timeFrame: At 24 months after intraoperative visit
measure: Assessment of Oxford Hip Score (OHS) completed by subjects with CoCrMo LOCK Bipolar femoral heads at 24 months after Bipolar Hemiarthroplasty.
timeFrame: At 24 months after intraoperative visit
measure: Assessment of Pain Likert-scale in subjects with CoCrMo LOCK Bipolar femoral heads at 24 months after Bipolar Hemiarthroplasty.
timeFrame: At 24 months after intraoperative visit
measure: Comparison between pre-operative and 4-month walking ability.
timeFrame: Performed at preoperative visit and 4months follow up visit
measure: Comparison between pre-operative and 4-month residential status.
timeFrame: Performed at preoperative visit and 4months follow up visit
Other outcomes:
Locations:
city: Celje
country: Slovenia
facility: Splošna bolnišnica Celje
Study officials:
References: