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Combined Use of PRP and Hyaluronic Acid for Infiltrative Treatment of Patients With Knee Osteoarthritis - Randomized Controlled Clinical Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device, Combination product, Biological
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

PRP+HA-23 is a double-blind randomized controlled clinical trial with 1:1:1 allocation. The objective of the study is to evaluate by a randomized controlled, double-blind clinical trial the efficacy and safety of viscosupplementation-associated PRP infiltration compared with PRP-only or HA-only infiltration for the treatment of patients with knee osteoarthritis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: f
View:

• Male or female patients, aged 40 to 75 years;

• Patients with symptomatic knee osteoarthritis (VAS pain score between ≥ 3 and ≤ 8);

• Unilateral involvement of symptomatology;

• Radiographic or MRI signs of degenerative pathology of knee cartilage (Kellgren-Lawrence grade 1-3);

• Failure, defined as the persistence of symptomatology, after at least one course of conservative treatment (pharmacological, physiotherapeutic or infiltrative treatment);

• Hemoglobin \> 11 g/dl; Platelet count \> 150,000 plt/mm3 (Recently performed CBC examination);

• Ability and consent of patients to actively participate in clinical follow-up;

• Signature of informed consent.

Locations
Other Locations
Italy
IRCCS Istituto Ortopedico Rizzoli
NOT_YET_RECRUITING
Bologna
Istituto Ortopedico Rizzoli
RECRUITING
Bologna
Contact Information
Primary
Davide Reale, MD
davide.reale@ior.it
0516366567
Backup
Roberta Licciardi, MSc
roberta.licciardi@ior.it
0516366567
Time Frame
Start Date: 2025-12-11
Estimated Completion Date: 2029-09
Participants
Target number of participants: 288
Treatments
Experimental: PRP+HA injection
This group of patients randomized into the treatment group, will undergo single intra-articular injection of autologous PRP+HA
Active_comparator: PRP injection
This group of patients randomized into the treatment group, will undergo single intra-articular injection of autologous PRP
Active_comparator: HA injection
This group of patients randomized into the treatment group, will undergo single intra-articular injection of HA
Related Therapeutic Areas
Sponsors
Leads: Istituto Ortopedico Rizzoli
Collaborators: University Hospital of Ferrara

This content was sourced from clinicaltrials.gov

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