Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Platelet Rich Plasma (PRP) Injections For Knee Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04852380
Recruitment Status : Completed
First Posted : April 21, 2021
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

It was conducted a prospective study with a series of 153 patients treated with PRP injections in patient affected by knee osteoarthritis. One independent observer performed clinical and functional evaluations at T0 (recruitment), T1 (one month after the injection), T2 (three months after the last injection) and T3 (six months after the last injection).

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Knee Score Society (KSS) score and the Visual Analogue Scale (VAS) were evaluated and recorded for each patient at each follow up.


Condition or disease Intervention/treatment
Knee Osteoarthritis Procedure: PRP injections

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 153 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Clinical Results Of Platelet Rich Plasma (PRP) Injections For Knee Osteoarthritis (KOA), Our Experience At Midterm Follow Up
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : January 1, 2020
Actual Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Patients treated by PRP injection Procedure: PRP injections
The 5 mL PRP concentrate was injected every week for three times, starting from recruitment. The patient was placed supine whit a knee flexion of 90°.All the procedures were carried out in an aseptic condition, injected in the knee soft spot through an anterior approach, using a 21-gauge needle.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in Visual Analogic Scale [ Time Frame: Day 0; Month 1; Month 3; Month 6 (after the injection) ]
    The knee pain was quantified using the Visual Analogic Scale ranging from 0 (no pain) to 10 (worst imaginable pain).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 81 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
One hundred and fiftythree patients referring to the Orthopaedic and Trauma Unit of the local University Hospital between January 2018 and January 2020 with knee osteoarthritis
Criteria

Inclusion Criteria:

  • Age between 40 and 81;
  • Body mass index (BMI) between 21.5 and 29.3;
  • Chronic history (for at least 4 months) of knee joint pain;
  • Radiographically documented knee osteoarthritis of grades 1 to 3 (Kellgren-Lawrence (K-L) radiographic classification scale)

Exclusion Criteria:

  • Radiographically severe documented knee osteoarthritis of grade 4 (K-L radiographic classification scale);
  • Previous femur and tibia fractures;
  • Knee previous surgical treatment (e.g., arthroscopy);
  • Hyaluronic acid infiltration within the previous six months;
  • Hemoglobin levels <10 g/dL;
  • History of oncohematological disease, infections, or immunodepression
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04852380


Locations
Layout table for location information
Italy
AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia
Bari, Italy, 70124
Sponsors and Collaborators
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
ClinicalTrials.gov Identifier: NCT04852380    
Other Study ID Numbers: PRP-Knee Osteoarthritis
First Posted: April 21, 2021    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari:
knee osteoarthritis (KOA); Platelet-rich plasma (PRP);
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases