Total hip arthroplasty for osteoarthritis or aseptic necrosis of the femoral head Surgery
Conditions
Interventions
60 patients undergoing hip surgery will be enrolled in a randomized phase IV study. Patients will be randomised in a double-blind manner into three medication arms administered in common practice. Ran
the 30th day of therapy, coinciding with the moment of surgery (T2)
the day after surgery (T3)
30 days after surgery (T4)
60 days after surgery, in correspondence with the final assessment and follow up (T5). T1 coincides with clinical examination, 15 days after the enrolment, without any blood collection.
On the day of
radiographs of the axial pelvis and in anteroposterior, to determine the extent of the degree of arthritis or necrosis
pain assessment will be done using the model inside the Harris Hip Score, by adding evaluations of pain intensity (NRI scale) during orthostatic and clinostat posture.
During the surgery, a bone mar
Sponsors
ISAL Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who started opioid analgesics category and will undergo total hip arthroplasty for osteoarthritis or aseptic necrosis of the femoral head 2. Patients who started NonSteroidal Anti-Inflammatory Drugs (NSAIDs) and will undergo total hip arthroplasty (THA) for osteoarthritis or aseptic necrosis of the femoral head 3. Males and female adults (from 18 years old)
Exclusion criteria
Exclusion criteria: 1. Unstable neurological pathologies 2. Uncompensated diabetes 3. Previous abdominal surgery with dynamic ileum risk 4. Viral infective pathologies 5. Patients unable to fill the informed consent form 6. Patients needing post-surgery mechanical ventilation 7. Patients attending a secondary surgery 8. Retreated patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Expression and functional characteristics of opioid receptors on the lymphocyte surface, measured using peripheral blood analysis (Immunophenotype analysis, Q-PCR, western blotting, ELISA) at T0, T2, T3, T4 and T5 2. Bone marrow morphological and morphometric evaluation, using bone marrow biopsy, hematoxylin/eosin staining protocol and cellular immune-phenotypic typization at T2 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Hip movement, stability, strength, presence of any deformities, joint and functional limitations, evaluated using the Harris Hip Score at T0, T1, T2, T4, T5 2. Degree of arthritis/necrosis, measured using axial and anteroposterior pelvic radiographs at T0 3. Pain intensity, measured using the NRI scale at T0, T1,T2, T3, T4, T5 4. Electrocardiogram, oxygen saturation, invasive and non-invasive blood pressure monitoring at T2 5. Side effects evaluation (tolerance or addiction) at T2, T4, T5 | — |
Countries
Italy
Outcome results
None listed