Clinical trial NCT06873568: Cephalic Femoral Heads Follow Up
Official title: A Post-market Study Evaluating Clinical and Safety Outcomes of Unipolar Hemiarthroplasty Using Cephalic Femoral Heads in Subjects with Hip Fracture
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hip Arthroplasty Replacement
Femoral Fractures
Keywords: femoral head
Partial hip arthroplasty
Lead sponsor: Limacorporate S.p.a
Sponsor class: INDUSTRY
First posted: 2025-03-12
Enrollment: 47
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 cephalic 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 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.

Detailed description: The study is aiming to demoranstrate safety and performance of cephalic 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 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.
* 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 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.
* 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 Cephalic femoral heads for any reason at 24 months after Unipolar Hemiarthroplasty.
timeFrame: From intraoperative to 24months follow up visit
Secondary outcomes:
measure: Evaluation of the dislocation rate (including close reduction) in subjects with Cephalic femoral heads from intra-operative to 24 months after Unipolar Hemiarthroplasty.
timeFrame: From intraoperative to 24months follow up visit
measure: Evaluation of the revision incidence of any hip component for any reason from intra-operative to 24 months after Unipolar Hemiarthroplasty.
timeFrame: From intraoperative to 24months follow up visit
measure: Evaluation of acetabular erosion (according to Baker classification) in subjects with Cephalic femoral heads at 12 months after Unipolar Hemiarthroplasty.
timeFrame: 12 months follow up visit
measure: Assessment of Harris Hip Score (HHS) at 24 months after Unipolar Hemiarthroplasty with Cephalic femoral heads.
timeFrame: 24 months follow up visit
measure: Assessment of Oxford Hip Score (OHS) completed by subjects with Cephalic femoral heads at 24 months after Unipolar Hemiarthroplasty.
timeFrame: 24 months follow up visit
measure: Assessment of Pain Likert-scale in subjects with Cephalic femoral heads at 24 months after Unipolar Hemiarthroplasty.
timeFrame: 24 months follow up visit
measure: Comparison between pre-operative and 4-month walking ability.
timeFrame: Performed at preoperative visit to 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: Presov
country: Slovakia
facility: University Hospital J.A. Reimana
Study officials:
References: