OsteoarthitisNCT07498660
PRP Injection Into the Sacroiliac Joint After Ipsilateral THA: Effects on Early Recovery and Function (SIJ-THA Randomized Trial)
A study testing PRP injection in people with Osteoarthitis and Sacro Iliac Joint Pain, run by Medical University of Warsaw at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Osteoarthitis, Sacro Iliac Joint Pain, Hip Arthroplasty, Total
- What is being tested?
- PRP injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 1 Apr 2026to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary osteoarthritis of the hip;
- qualification for elective total hip arthroplasty (THA);
- age ≥45 years;
- written informed consent;
- ability to understand Polish.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lapinski, MD contact
Poland1 site
Department of Orthopaedics and Rehabilitation, Medical University of Warsaw
Warsaw
Stolarczyk, MD, PhD, +48 22 47 35 219, artur.stolarczyk@wum.edu.pl
About this study
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)
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).
Read more
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.
- Being tested
- PRP injection, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP injectionProcedure or surgery
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm: PRP Injection (Sacroiliac Joint) | Experimental | Not described Receives: Procedure: PRP injection |
| Placebo Comparator: Saline injection (SIJ) | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthitisStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Artur Stolarczyk, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07498660
- Sponsor's protocol ID
- SIJ-THA Randomized Trial
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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 at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07498660
- Acronym / sponsor ID
- SIJ-THA Randomized Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm: PRP Injection (Sacroiliac Joint) | Experimental | Procedure: PRP injection |
| Placebo Comparator: Saline injection (SIJ) | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- primary osteoarthritis of the hip;
- qualification for elective total hip arthroplasty (THA);
- age ≥45 years;
- written informed consent;
- ability to understand Polish.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRP injectionPlatelet-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. | Procedure or surgery | Experimental Arm: PRP Injection (Sacroiliac Joint) |
| PlaceboA 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. | Other | Placebo Comparator: Saline injection (SIJ) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Background1. 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.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lapinski, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP injection in people with Osteoarthitis and Sacro Iliac Joint Pain, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stolarczyk, MD, PhD, Professor (+48 22 47 35 219, artur.stolarczyk@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hip function measured by the Harris Hip Score (HHS) from baseline to 6 weeks postoperatively. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07498660, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.