Hip Arthroplasty, Total, Osteoarthitis, Sacro Iliac Joint Pain, Sacro-Iliac Spondylosis
Conditions
Brief summary
The study is an interventional, randomized, open-label (non-blinded), placebo-controlled trial. Preoperatively, patients scheduled for primary total hip arthroplasty (THA) will undergo a clinical examination in the Orthopaedic Department. Clinical tests will be performed to confirm sacroiliac joint (SIJ) dysfunction on the operated side. In addition, low-dose computed tomography (CT) will be used to assess structural changes in the SIJ. All patients will complete patient-reported outcome measures related to the hip joint, including the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Harris Hip Score (HHS), as well as SIJ-related assessments, including the Oswestry Disability Index (ODI). Pain intensity will be assessed using the Visual Analogue Scale (VAS). Following THA, patients will be randomly allocated into two groups during their hospital stay. In the intervention group, platelet-rich plasma (PRP) will be injected into the sacroiliac joint, whereas the control group will receive an injection of normal saline. All injections will be performed in the operating theatre. At discharge, patients will be scheduled for follow-up visits at 2, 6, and 12 weeks postoperatively. At each follow-up, patient-reported outcomes will be collected, including WOMAC and HHS for hip function, ODI for SIJ-related disability, and VAS for pain assessment of both the hip and sacroiliac joint.
Interventions
PROCEDUREPRP injection
Platelet-rich plasma (PRP) will be prepared from autologous peripheral blood using a standardized centrifugation protocol in accordance with the manufacturer's instructions. The PRP will be obtained intraoperatively under sterile conditions. A single injection will be administered into the sacroiliac joint on the operated side under sterile conditions in the operating theatre. The injection will be performed using anatomical landmarks and/or imaging guidance, according to institutional practice. The volume of PRP administered will be standardized across participants.
OTHERPlacebo
A single injection of sterile 0.9% sodium chloride (normal saline) will be administered into the sacroiliac joint on the operated side under sterile conditions in the operating theatre. The procedure will be performed using the same technique, anatomical approach, and guidance method as in the experimental (PRP) group. The injection volume, timing, and procedural conditions will be identical to those used in the PRP group to ensure comparability.
Sponsors
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* primary osteoarthritis of the hip; * qualification for elective total hip arthroplasty (THA); * age ≥45 years; * written informed consent; * ability to understand Polish.
Exclusion criteria
* prior surgical treatment of the hip or sacroiliac joint; * malignancy; * developmental dysplasia of the hip; * rheumatologic diseases (rheumatoid arthritis, ankylosing spondylitis, juvenile idiopathic arthritis); * neurological or psychiatric disorders; * allergy to local anesthetics.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in hip function measured by the Harris Hip Score (HHS) from baseline to 6 weeks postoperatively. | 6 weeks | The primary outcome is the change in Harris Hip Score (HHS) between the preoperative assessment and 6 weeks following total hip arthroplasty. |
Countries
Poland
Contacts
CONTACTStolarczyk, MD, PhD, Professor
CONTACTLapinski, MD
Outcome results
None listed