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NCT Number: NCT07498660

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

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Key information

Conditions

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

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthopaedics and Rehabilitation, Medical University of Warsaw

Warsaw, Poland

Location contact

Stolarczyk, MD, PhD

CONTACT

[email protected]

+48 22 47 35 219

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in hip function measured by the Harris Hip Score (HHS) from baseline to 6 weeks postoperatively.

    Time frame: 6 weeks

    The primary outcome is the change in Harris Hip Score (HHS) between the preoperative assessment and 6 weeks following total hip arthroplasty.

Study contacts

Contact information is provided by the study sponsor or research team.

Lapinski, MD

CONTACT

[email protected]

Stolarczyk, MD, PhD, Professor

CONTACT

[email protected]

+48 22 47 35 219

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study 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)

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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