PRP Injection Into the Sacroiliac Joint After Ipsilateral THA: Effects on Early Recovery and Function (SIJ-THA Randomized Trial)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PRP injection, Placebo.
- Who it may be relevant to
- Registry conditions: Osteoarthitis, Sacro Iliac Joint Pain, Hip Arthroplasty, Total, Sacro-Iliac Spondylosis. Basic parameters: from 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Platelet-Rich Plasma Injection Into the Sacroiliac Joint After Ipsilateral Total Hip Arthroplasty on Early Rehabilitation and Patient Function: A Randomized Trial (SIJ-THA Trial)
Overview
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
- Procedure PRP 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. - Other Placebo
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.
Primary outcome measures
- Change in hip function measured by the Harris Hip Score (HHS) from baseline to 6 weeks postoperatively. [Time frame: 6 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Poland · 1 center
- Department of Orthopaedics and Rehabilitation, Medical University of Warsaw — Warsaw
Publications
- 1. Ian D Learmonth, Claire Young, Cecil Rorabeck: The operation of the century: total hip replacement. Lancet 2007; 370: 1508-19 Published Online March 29, 2007 DOI:10.1016/S0140- 6736(07)60457. 2. The AJRR 2024 Annual Report 3. AOANJRR AnnualReports 2024 4. The NJR's 21st Annual Report 5. David P Newman 1, Adam T Soto 1: Sacroiliac Joint Dysfunction: Diagnosis and Treatment. Am Fam Physician.
Identifiers
NCT: NCT07498660 · SIJ-THA Randomized Trial