Trial Outcomes & Findings for Precision Assessment of Platelet Rich Plasma for Joint Preservation (NCT NCT03460236)

NCT ID: NCT03460236

Last Updated: 2025-05-23

Results Overview

Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain scores were determined through standardized questionnaires to evaluate osteoarthritis of the knee. The KOOS Pain scale consists of 9 questions with each response valued on an ordinal scale 0-4. KOOS Pain scores are transformed so that higher scores indicate less pain. Successful pain improvement is determined from the number of participants with changes in KOOS Pain in excess of the previously determined threshold of 12.4pts for minimal important change after non-surgical intervention for knee pain.

• Recruitment status: COMPLETED
• Target enrollment: 90 participants
• Primary outcome timeframe: Baseline to 6 months
• Results posted on: 2025-05-23

Participant Flow

After enrollment, 16 failed radiographic screening before assignment to the study.

Participant milestones

Measure	Platelet Rich Plasma Symptomatic early knee osteoarthritis subjects who have elected to receive PRP treatment.
Overall Study STARTED	90
Overall Study COMPLETED	63
Overall Study NOT COMPLETED	27

Reasons for withdrawal

Measure	Platelet Rich Plasma Symptomatic early knee osteoarthritis subjects who have elected to receive PRP treatment.
Overall Study failed radiographic screening	16
Overall Study Withdrawal by Subject	11

Baseline Characteristics

Precision Assessment of Platelet Rich Plasma for Joint Preservation

Baseline characteristics by cohort

Measure	Platelet Rich Plasma Injection Group n=90 Participants Symptomatic early knee osteoarthritis subjects who have elected to receive PRP treatment.
Age, Continuous	55 years n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants
Sex: Female, Male Male	48 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	74 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	68 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Body Mass Index	27.78499 kg/m² n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: The 63 participants who completed both baseline and 6-month follow-up patient reported outcome surveys.

Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain scores were determined through standardized questionnaires to evaluate osteoarthritis of the knee. The KOOS Pain scale consists of 9 questions with each response valued on an ordinal scale 0-4. KOOS Pain scores are transformed so that higher scores indicate less pain. Successful pain improvement is determined from the number of participants with changes in KOOS Pain in excess of the previously determined threshold of 12.4pts for minimal important change after non-surgical intervention for knee pain.

Outcome measures

Measure	Platelet Rich Plasma (PRP) Recipients n=63 Participants Symptomatic early knee osteoarthritis subjects who have elected to receive PRP treatment.
Number of Participants With Successful Knee Pain Improvement Over 6 Months Following PRP Injections	25 Participants

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: The 63 participants who completed both baseline and 6-month follow-up patient reported outcome surveys.

Knee Function was determined from Western Ontario and McMaster University Osteoarthritis Index (WOMAC) scores, standardized questionnaires to evaluate osteoarthritis of the knee. The WOMAC Function scale consists of 17 questions, with each response valued on an ordinal scale of 0-4. Higher numbers indicate more physical disability. Successful functional improvement is determined from the number of participants with changes in the WOMAC Function score in excess of the previously determined threshold of -17pts for minimal important functional change after non-surgical intervention.

Outcome measures

Measure	Platelet Rich Plasma (PRP) Recipients n=63 Participants Symptomatic early knee osteoarthritis subjects who have elected to receive PRP treatment.
Number of Participants With Successful Knee Function Improvement Over 6 Months Following PRP Injections	12 Participants

Adverse Events

Platelet Rich Plasma (PRP) Recipients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christine Hoang, Clinical Research Coordinator

Stanford University

Phone: 650-721-7630

Email: c1hoang@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place