Use of Leukocyte-Rich PRP or Leukocyte-Free PRP in the Treatment of Hip Osteoarthritis. Double-blind Controlled Randomized Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The aim of the study is to compare the efficacy up to 12 months of two different types of PRP (PRP with leukocytes vs PRP depleted of leukocytes) in the echo-guided infiltrative treatment of hip OA by including 230 patients in the study and evaluating them through subjective (using the WOMAC score as the primary outcome) and objective clinical scores.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Maximum Age: 70
Healthy Volunteers: f
View:

• Signs and symptoms of hip OA (pain intensity of at least 4 points and not more than 8 of VAS pain - 0-10 scale in the previous week);

• Radiographic signs of hip OA (Grade 1-2 according to Tonnis classification) or MRI signs (chondropathy or minimal labrum degeneration without acute lesions) even if Grade 0.

• Unilateral involvement; Hemoglobin \> 11 g/dl;

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

• Negative serological tests for HBsAg, HCV Ab, HIV-1-2 Ab

• No clinically significant electrocardiographic changes (Recently performed ECG).

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

Locations
Other Locations
Italy
Istituto Ortopedico Rizzoli
RECRUITING
Bologna
Contact Information
Primary
Dante Dallari, MD
dante.dallari@ior.it
6366318
Backup
Roberta Licciardi, MSc
roberta.licciardi@ior.it
6366567
Time Frame
Start Date: 2022-10-05
Estimated Completion Date: 2026-10
Participants
Target number of participants: 230
Treatments
Experimental: Leukocyte Rich-PRP Injection
Three infiltrations of Leukocyte Rich Platelet Rich Plasma~1 infiltration weekly, for 3 weeks
Active_comparator: Leukocyte Poor- PRP Injection
Three infiltrations of Leukocyte Poor-Platelet Rich Plasma~1 infiltration weekly, for 3 weeks.
Related Therapeutic Areas
Sponsors
Leads: Istituto Ortopedico Rizzoli

This content was sourced from clinicaltrials.gov