Femoral Fractures, Hip Arthroplasty Replacement
Conditions
Keywords
femoral head, Partial hip arthroplasty
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).
Interventions
None listed
Sponsors
Limacorporate S.p.a
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the revision rate of Cephalic femoral heads for any reason at 24 months after Unipolar Hemiarthroplasty. | From intraoperative to 24months follow up visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the revision incidence of any hip component for any reason from intra-operative to 24 months after Unipolar Hemiarthroplasty. | From intraoperative to 24months follow up visit | — |
| Evaluation of acetabular erosion (according to Baker classification) in subjects with Cephalic femoral heads at 12 months after Unipolar Hemiarthroplasty. | 12 months follow up visit | 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 |
| Assessment of Harris Hip Score (HHS) at 24 months after Unipolar Hemiarthroplasty with Cephalic femoral heads. | 24 months follow up visit | The Harris Hip Score goes from 0 to 100, which is the best result. |
| Evaluation of the dislocation rate (including close reduction) in subjects with Cephalic femoral heads from intra-operative to 24 months after Unipolar Hemiarthroplasty. | From intraoperative to 24months follow up visit | — |
| Assessment of Pain Likert-scale in subjects with Cephalic femoral heads at 24 months after Unipolar Hemiarthroplasty. | 24 months follow up visit | The pain Likert-scale is a 6-point scale: * severe and spontaneous * severe when walking * tollerable * occurs after activity * light intermittent * no pain |
| Comparison between pre-operative and 4-month walking ability. | Performed at preoperative visit to 4months follow up visit | Functional evaluation |
| Comparison between pre-operative and 4-month residential status. | Performed at preoperative visit and 4months follow up visit | Daily habit |
| Assessment of Oxford Hip Score (OHS) completed by subjects with Cephalic femoral heads at 24 months after Unipolar Hemiarthroplasty. | 24 months follow up visit | The Oxford Hip Score goes from 0 to 48, with 48 being the best outcome |
Countries
Slovakia
Contacts
Primary ContactMonica Novello
Backup ContactFrancesca Citossi
Outcome results
None listed