PRP Injection Into the Sacroiliac Joint After Ipsilateral THA: Effects on Early Recovery and Function (SIJ-THA Randomized Trial)

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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sacro Iliac Joint Pain; Sacro-Iliac Spondylosis; Osteoarthitis; Hip Arthroplasty, Total
• Intervention / Treatment: Procedure: PRP injection; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stolarczyk, MD, PhD, Professor; Phone Number: +48 22 47 35 219; Email: artur.stolarczyk@wum.edu.pl
• Study Contact Backup: Name: Lapinski, MD; Email: marcin.lapinski@wum.edu.pl

Study Locations

• Poland
  • Warsaw, Poland
    • Department of Orthopaedics and Rehabilitation, Medical University of Warsaw
    • Contact: Stolarczyk, MD, PhD; Phone Number: +48 22 47 35 219; Email: artur.stolarczyk@wum.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Arm: PRP Injection (Sacroiliac Joint)	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. The volume of PRP administered will be standardized across participants.
Placebo Comparator: Placebo Comparator: Saline injection (SIJ)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Medical University of Warsaw

Publications and helpful links

General 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. 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.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: March 23, 2026
• First Submitted That Met QC Criteria: March 23, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SIJ-THA Randomized Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No