How Does Platelet Dose Impact Clinical Outcomes After PRP Treatment?

NCT05330689 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: PRPTreatment
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine which platelet rich plasma (PRP) injection dosage provides the most improvement in a patient's knee pain level at 26 weeks post-injection.

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Platelet rich plasma

Outcome Measures

Primary Outcomes (2)

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Patient reported outcome measure: Consists of 5 subscales, one of which is "Pain". A normalized score (100 indicating no pain and 0 indicating extreme pain) is calculated for this subscale.

  Baseline to 26 weeks post injections

• Western Ontario and McMaster University's Osteoarthritis Index (WOMAC)

  Patient-reported outcome measure: The scores for each subscale are summed up, with a possible score range of 0-20 for Pain. Higher scores indicate worse pain.

  Baseline to 26 weeks post injections

Secondary Outcomes (1)

• Visual Analog Scale (VAS)

  Baseline, 6 weeks, 12 weeks, 26 weeks post injections

Study Arms (5)

Sample group 1

ACTIVE COMPARATOR

Sample of subjects with primary osteoarthritis of the knee

Biological: PRP injection dose (<5 billion platelets)

Sample group 2

ACTIVE COMPARATOR

Sample of subjects with primary osteoarthritis of the knee

Biological: PRP injection dose (between 5 and <10 billion platelets)

Sample group 3

ACTIVE COMPARATOR

Sample of subjects with primary osteoarthritis of the knee

Biological: PRP injection dose (between 10 and <20 billion platelets)

Sample group 4

ACTIVE COMPARATOR

Sample of subjects with primary osteoarthritis of the knee

Biological: PRP injection dose (20 billion or greater platelets)

Sample group 5

PLACEBO COMPARATOR

Sample of subjects with primary osteoarthritis of the knee

Other: Saline injection control

Interventions

PRP injection dose (<5 billion platelets) BIOLOGICAL

PRP injection with a dose of platelets that is less than 5 billion platelets

Sample group 1

PRP injection dose (between 5 and <10 billion platelets) BIOLOGICAL

PRP injection with a dose of platelets that is between 5 and \<10 billion platelets

Sample group 2

PRP injection dose (between 10 and <20 billion platelets) BIOLOGICAL

PRP injection with a dose of platelets that is between 10 and \<20 billion platelets

Sample group 3

PRP injection dose (20 billion or greater platelets) BIOLOGICAL

PRP injection with a dose of platelets that is 20 billion platelets or greater

Sample group 4

Saline injection control OTHER

Saline control

Sample group 5

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Previous diagnosis of unilateral, primary osteoarthritis of the knee
• Knee pain; duration of symptoms \> 4 weeks
• K-L grade 0-4

You may not qualify if:

• Under 40 years of age; over 80 years of age
• Bilateral knee pain
• Duration of symptoms \< 4 weeks
• NSAID or clopidogrel use in the last 7 days
• High risk of a thrombotic event if discontinuing NSAID or clopidogrel for four weeks.
• Steroid use in the last 6 weeks
• Active diagnosis of leukopenia/anemia/thrombocytopenia

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Leon Scott, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 9, 2022
• First Posted: April 15, 2022
• Study Start: March 6, 2022
• Primary Completion: September 7, 2022
• Study Completion: September 7, 2022
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)