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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm: PRP Injection (Sacroiliac Joint) | Experimental |
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| Placebo Comparator: Saline injection (SIJ) | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRP injection | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hip function measured by the Harris Hip Score (HHS) from baseline to 6 weeks postoperatively. | The primary outcome is the change in Harris Hip Score (HHS) between the preoperative assessment and 6 weeks following total hip arthroplasty. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stolarczyk, MD, PhD, Professor | Contact | +48 22 47 35 219 | artur.stolarczyk@wum.edu.pl | |
| Lapinski, MD | Contact | marcin.lapinski@wum.edu.pl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Orthopaedics and Rehabilitation, Medical University of Warsaw | Warsaw | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. 2022 Mar 1;105(3):239-245. 6. Ariella Gartenberg1 · Adam Nessim1 · Woojin Cho : Sacroiliac joint dysfunction: pathophysiology, diagnosis, and treatment. EurSpine J 2021 Oct;30(10):2936-2943. doi:10.1007/s00586-021-06927-9. 7. Ayumi Kaneuji, Makoto Fukui, Eiji Takahashi, Yusuke Sanji, Hiroaki Hirata, Norio Kawahara : Hip-sacroiliac joint-spine syndrome in total hip arthroplasty patients. Sci Rep 2024 Feb 15;14:3813. doi: 10.1038/s41598-024-54472-4. 8. Maki Asada, Daisaku Tokunaga, Yuji Arai, Ryo Oda, Hiroyoshi Fujiwara, Kei Yamada and Toshikazu Kubo: Degeneration of the Sacroiliac Joint in Hip Osteoarthritis Patients: A Three-Dimensional Image Analysis. Journal of the BelgianSociety of Radiology. 2019; 103(1): 36, 1-7. DOI: 10.5334/jbsr.1648. 9. Effectiveness of Ultrasound-Guided Platelet-Rich Plasma Injections in Relieving Sacroiliac Joint Dysfunction. Patrick Wallace, DO, MS, Laurie Bezjian Wallace, DO, Sarah Tamura, MS, Kirk Prochnio, PA-C, Kyle Morgan, DO, and Douglas Hemler, MD. |
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Individual participant data (IPD) underlying the results reported in this study will be made available upon reasonable request to the corresponding author. Data will be de-identified and shared for scientific research purposes only, following approval of a methodologically sound proposal and in accordance with institutional and ethical regulations. Data will be available beginning 6 months after publication and ending 3 years after publication.
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| Placebo | Other | 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. |
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