Trial Outcomes & Findings for Hyaluronic Acid vs Platelet Rich Plasma: Effects on Clinical Outcomes and Intra-articular Biology for the Treatment of Knee Osteoarthritis (NCT NCT02588872)

Results Overview

This is a scale from 1-100, 100 being high function and 1 being very poor function that will be assessed via paper questionnaire at the delineated time intervals. The Primary outcome assessed will be at an average of 1-year post treatment.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

111 participants

Primary outcome timeframe

This will be assessed as a change from pre-treatment visit to 1 year post treatment.

Results posted on

2023-03-14

Participant Flow

Participant milestones

Participant milestones
Measure	Hyaluronic Acid (HA) Hyaluronic acid administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of ultra high molecular weight hyaluronan (16mg) in a 2mL injection. Hyaluronic Acid	Platelet-rich Plasma (PRP) Platelet-rich plasma administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 4mL in volume. Platelet-rich Plasma (PRP)
Overall Study STARTED	59	52
Overall Study COMPLETED	59	52
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

There were a total of 12 patients that were lost to follow-up, 3 in the PRP group and 9 in the HA group thus the final numbers included in analysis was 99 total patients instead of 111.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hyaluronic Acid (HA) n=59 Participants Hyaluronic acid administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of ultra high molecular weight hyaluronan (16mg) in a 2mL injection. Hyaluronic Acid	Platelet-rich Plasma (PRP) n=52 Participants Platelet-rich plasma administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 4mL in volume. Platelet-rich Plasma (PRP)	Total n=111 Participants Total of all reporting groups
Age, Continuous	56.8 years STANDARD_DEVIATION 10.5 • n=59 Participants	55.9 years STANDARD_DEVIATION 10.4 • n=52 Participants	56.3 years STANDARD_DEVIATION 10.4 • n=111 Participants
Sex: Female, Male Female	30 Participants n=50 Participants • There were a total of 12 patients that were lost to follow-up, 3 in the PRP group and 9 in the HA group thus the final numbers included in analysis was 99 total patients instead of 111.	21 Participants n=49 Participants • There were a total of 12 patients that were lost to follow-up, 3 in the PRP group and 9 in the HA group thus the final numbers included in analysis was 99 total patients instead of 111.	51 Participants n=99 Participants • There were a total of 12 patients that were lost to follow-up, 3 in the PRP group and 9 in the HA group thus the final numbers included in analysis was 99 total patients instead of 111.
Sex: Female, Male Male	20 Participants n=50 Participants • There were a total of 12 patients that were lost to follow-up, 3 in the PRP group and 9 in the HA group thus the final numbers included in analysis was 99 total patients instead of 111.	28 Participants n=49 Participants • There were a total of 12 patients that were lost to follow-up, 3 in the PRP group and 9 in the HA group thus the final numbers included in analysis was 99 total patients instead of 111.	48 Participants n=99 Participants • There were a total of 12 patients that were lost to follow-up, 3 in the PRP group and 9 in the HA group thus the final numbers included in analysis was 99 total patients instead of 111.
BMI	29 kg/m^2 STANDARD_DEVIATION 6.4 • n=59 Participants	27.4 kg/m^2 STANDARD_DEVIATION 3.9 • n=52 Participants	28.2 kg/m^2 STANDARD_DEVIATION 5.1 • n=111 Participants

PRIMARY outcome

Timeframe: This will be assessed as a change from pre-treatment visit to 1 year post treatment.

Population: 9 HA patients and 3 PRP from the original cohort were lost to follow up which is why 50 HA and 49 PRP patients were included in final analysis.

This is a scale from 1-100, 100 being high function and 1 being very poor function that will be assessed via paper questionnaire at the delineated time intervals. The Primary outcome assessed will be at an average of 1-year post treatment.

Outcome measures

Outcome measures
Measure	Hyaluronic Acid (HA) n=50 Participants Hyaluronic acid administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of ultra high molecular weight hyaluronan (16mg) in a 2mL injection. Hyaluronic Acid	Platelet-rich Plasma (PRP) n=49 Participants Platelet-rich plasma administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 4mL in volume. Platelet-rich Plasma (PRP)
International Knee Documentation Committee Score (IKDC	65.5 units on a scale Standard Error 3.6	55.8 units on a scale Standard Error 3.8

SECONDARY outcome

Timeframe: This will be assessed as a change from pre-treatment visit to 1 year post treatment.

This is a scale from 1-100, 100 being the worst pain imaginable and 1 being no pain at all that will be assessed via paper questionnaire at the delineated time intervals. The Primary outcome assessed will be at an average of 1-year post treatment.

Outcome measures

Outcome measures
Measure	Hyaluronic Acid (HA) n=50 Participants Hyaluronic acid administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of ultra high molecular weight hyaluronan (16mg) in a 2mL injection. Hyaluronic Acid	Platelet-rich Plasma (PRP) n=49 Participants Platelet-rich plasma administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 4mL in volume. Platelet-rich Plasma (PRP)
Visual Analogue Scale (VAS)	57.3 units on a scale Standard Error 3.8	44 units on a scale Standard Error 4.6

SECONDARY outcome

Timeframe: This will be assessed as a change from pre-treatment visit to 1 year post treatment. 6-weeks post-treatment, 6-months post treatment, and finally at 1-year post treatment will be documented for the purpose of trending data.

This is a scale from 1-100, 100 being high function and 1 being very poor function that will be assessed via paper questionnaire at the delineated time intervals. The Primary outcome assessed will be at an average of 1-year post treatment.

Outcome measures

Outcome measures
Measure	Hyaluronic Acid (HA) n=50 Participants Hyaluronic acid administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of ultra high molecular weight hyaluronan (16mg) in a 2mL injection. Hyaluronic Acid	Platelet-rich Plasma (PRP) n=49 Participants Platelet-rich plasma administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 4mL in volume. Platelet-rich Plasma (PRP)
Western Ontario and McMaster Universities Arthritis Index	4 units on a scale Standard Error 0.6	3.02 units on a scale Standard Error 0.48

SECONDARY outcome

Timeframe: This will be assessed as a change from pre-treatment visit to 1 year post treatment.

This is a scale from 1-100, 100 being high function and 1 being very poor function that will be assessed via paper questionnaire at the delineated time intervals. The Primary outcome assessed will be at an average of 1-year post treatment.

Outcome measures

Outcome measures
Measure	Hyaluronic Acid (HA) n=50 Participants Hyaluronic acid administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of ultra high molecular weight hyaluronan (16mg) in a 2mL injection. Hyaluronic Acid	Platelet-rich Plasma (PRP) n=49 Participants Platelet-rich plasma administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 4mL in volume. Platelet-rich Plasma (PRP)
Lysholm Knee Score	55.8 units on a scale Standard Error 3.8	65.5 units on a scale Standard Error 3.6

SECONDARY outcome

Timeframe: Primary outcome will be change from pre-treatment to 6-month post treatment.

Population: IL-1B

ELISA analysis will be performed for the following biological markers: IL-1β, IL-1ra, IL-6, IL-8, TNFα

Outcome measures

Outcome measures
Measure	Hyaluronic Acid (HA) n=50 Participants Hyaluronic acid administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of ultra high molecular weight hyaluronan (16mg) in a 2mL injection. Hyaluronic Acid	Platelet-rich Plasma (PRP) n=49 Participants Platelet-rich plasma administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 4mL in volume. Platelet-rich Plasma (PRP)
Biologic Testing of Synovial Fluid Via ELISA Assays	0.14 units on a scale Standard Error 0.005	0.34 units on a scale Standard Error 0.16

Adverse Events

Hyaluronic Acid (HA)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Platelet-rich Plasma (PRP)

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

Mukesh Ahuja

Rush University Medical Center

Phone: 312-432-2380

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place