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

NCT07498660 | Not Yet Recruiting

• 1 other identifier: SIJ-THA Randomized Trial
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthitis; Sacro Iliac Joint Pain; Hip Arthroplasty, Total; Sacro-Iliac Spondylosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Experimental Arm: PRP Injection (Sacroiliac Joint)

EXPERIMENTAL

Procedure: PRP injection

Placebo Comparator: Saline injection (SIJ)

PLACEBO COMPARATOR

Other: Placebo

Interventions

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.

Placebo Comparator: Saline injection (SIJ)

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.

Experimental Arm: PRP Injection (Sacroiliac Joint)

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• primary osteoarthritis of the hip;
• qualification for elective total hip arthroplasty (THA);
• age ≥45 years;
• written informed consent;
• ability to understand Polish.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Orthopaedics and Rehabilitation, Medical University of Warsaw

Warsaw, Poland

Location

Related Publications (1)

• 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.

  BACKGROUND

Central Study Contacts

Stolarczyk, MD, PhD, Professor

CONTACT

+48 22 47 35 219; artur.stolarczyk@wum.edu.pl

Lapinski, MD

CONTACT

marcin.lapinski@wum.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

PL (1)