Platelet-rich plasma injections induce disease-modifying effects in the treatment of osteoarthritis in animal models.
Angelo Boffa, Manuela Salerno, Giulia Merli...
https://pubmed.ncbi.nlm.nih.gov/34341845Actively Recruiting
Phase Not Applicable
Age: 40Years - 75Years
All Genders
ID06685120
Combined Use of PRP and Hyaluronic Acid for Infiltrative Treatment of Patients With Knee Osteoarthritis - Randomized Controlled Clinical Study
Led by Istituto Ortopedico Rizzoli · Updated on 2026-02-03
288
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
I
Istituto Ortopedico Rizzoli
Lead Sponsor
U
University Hospital of Ferrara
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the treatment of knee osteoarthritis in adults aged 40 to 75 through a double-blind, randomized controlled clinical trial. The study aims to compare the effectiveness and safety of combined platelet-rich plasma (PRP) with hyaluronic acid (HA) injections against PRP alone or HA alone. This approach is designed to improve symptoms in patients with degenerative knee cartilage conditions who have not responded to conservative treatments. Participants will be randomly assigned to one of three groups: one receiving a single injection of PRP combined with HA, another receiving PRP alone, and the third receiving HA alone. All patients will undergo blood collection to prepare PRP, although only the PRP and PRP+HA groups will receive PRP injections. The HA injection is administered first in the combined group, followed by PRP, to maintain sterility and ensure proper delivery. During the study, participants will be assessed before treatment and at 1, 3, 6, 12, and 24 months post-injection. Medical staff will perform clinical evaluations, including functional questionnaires and objective measures like range of motion and knee circumference. The main outcome measured is the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 12 months, with additional assessments of pain, activity level, and quality of life occurring throughout the follow-up period. The total participation may extend up to two years to monitor safety and treatment effects.
CONDITIONS
Brief Title
Combined Use of PRP and Hyaluronic Acid for Infiltrative Treatment of Patients With Knee Osteoarthritis
Who Can Participate
Age: 40Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 40 to 75 years
- Symptomatic knee osteoarthritis with pain score between 3 and 8
- Symptoms affecting only one knee
- Radiographic or MRI signs of knee cartilage degeneration (Kellgren-Lawrence grade 1-3)
- Persistent symptoms after at least one course of conservative treatment
- Hemoglobin above 11 g/dl and platelet count above 150,000 plt/mm3
- Ability and willingness to participate in follow-up
- Signed informed consent form
You will not qualify if you...
- Unable to give consent
- Knee joint injection of other substances within the past 6 months
- Knee surgery within the past 12 months
- Malignant tumors
- Rheumatic diseases
- Uncontrolled diabetes
- Blood clotting disorders
- Anticoagulant or anti-platelet therapy that cannot be stopped
- Uncontrolled thyroid disorders
- Abuse of alcohol, drugs, or medications
- Body mass index over 35
- Use of NSAIDs within 3 days before blood sampling
- Cardiovascular conditions contraindicating blood collection
- Recent blood test showing hemoglobin below 11 g/dl or low platelets
- Pregnant or fertile women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single day
Participants undergo a single intra-articular injection of either PRP combined with hyaluronic acid, PRP alone, or hyaluronic acid alone following blood sampling.
1 treatment visit (in-person)
Follow-up
Duration - 24 months
Participants are clinically evaluated and complete questionnaires before treatment and at 1, 3, 6, 12, and 24 months after treatment to assess clinical and functional outcomes.
6 follow-up visits (in-person)
Trial Site Locations
Total: 2 locations
1
IRCCS Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
Not Yet Recruiting
2
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
Actively Recruiting
Loading map...
Research Team
D
Davide Reale, MD
R
Roberta Licciardi, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
PRP Injections for the Treatment of Knee Osteoarthritis: A Meta-Analysis of Randomized Controlled Trials.
Giuseppe Filardo, Davide Previtali, Francesca Napoli...
https://pubmed.ncbi.nlm.nih.gov/32551947Synergistic anabolic actions of hyaluronic acid and platelet-rich plasma on cartilage regeneration in osteoarthritis therapy.
Wei-Hong Chen, Wen-Cheng Lo, Wei-Che Hsu...
https://pubmed.ncbi.nlm.nih.gov/25176059Mechanistic insight into hyaluronic acid and platelet-rich plasma-mediated anti-inflammatory and anti-apoptotic activities in osteoarthritic mice.
Chi-Sheng Chiou, Chi-Ming Wu, Navneet Kumar Dubey...
https://pubmed.ncbi.nlm.nih.gov/30582743Efficacy and safety of platelet-rich plasma combined with hyaluronic acid versus platelet-rich plasma alone for knee osteoarthritis: a systematic review and meta-analysis.
Qing Zhang, Tuodong Liu, Yuan Gu...
https://pubmed.ncbi.nlm.nih.gov/36403041Randomized controlled trial comparing hyaluronic acid, platelet-rich plasma and the combination of both in the treatment of mild and moderate osteoarthritis of the knee.
José F S D Lana, Adam Weglein, Steve E Sampson...
https://pubmed.ncbi.nlm.nih.gov/28096631