Hyaluronic Acid vs Platelet Rich Plasma: Effects on Clinical Outcomes and Intra-articular Biology for the Treatment of Knee Osteoarthritis
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/21/2016 |
| Start Date: | August 2011 |
| End Date: | April 2015 |
Hyaluronic Acid vs Platelet Rich Plasma: Prospective Double-blind Randomized Controlled Trial Comparing Clinical Outcomes and the Effects on Intra-articular Biology for the Treatment of Knee Osteoarthritis
In this, prospective, double-blind study, patients with mild to moderate symptomatic knee
osteoarthritis will be randomized to receive either a series of leukocyte poor,
platelet-rich plasma or hyaluronic acid injections under ultrasound guidance. Clinical data
in the form of subjective outcome measures will be collected pre-treatment and at four time
intervals across a 1-year period. Synovial fluid will also collected for analysis of pro-
and anti-inflammatory markers pre-treatment, and at 12 and 24 weeks.
osteoarthritis will be randomized to receive either a series of leukocyte poor,
platelet-rich plasma or hyaluronic acid injections under ultrasound guidance. Clinical data
in the form of subjective outcome measures will be collected pre-treatment and at four time
intervals across a 1-year period. Synovial fluid will also collected for analysis of pro-
and anti-inflammatory markers pre-treatment, and at 12 and 24 weeks.
The objective of this double-blind prospective randomized clinical trial is to compare the
effects of PRP to HA in patients with mild to moderate OA using biologic and clinical
correlates of outcomes associated with the treatment of OA. The investigators will test the
null hypothesis that there are no differences in clinical outcomes as measured by validated
clinical scoring systems for OA, nor is there any difference in intra-articular biology
between groups of patients treated with HA and those treated with PRP over time.
This study was a prospective, randomized, double blind, comparative clinical trial with an
allocation ratio of 1:1 that underwent IRB approval at the principal institution. Between
2011 and 2014 patients will be screened for participation. All comers with a diagnosis of
osteoarthritis of the knee between 18 and 80 years of age will be screened.
Treatment and Evaluation Patients who meet inclusion criteria will be randomized via an
electronic randomization process into two groups: one receiving intra-articular PRP and the
other, intra-articular HA. Non-clinical staff will perform randomization, clinical staff
performed the injections, and results and analyses will be performed by the primary research
team. Patients and the primary research team performing analysis will be blinded to
assignments. All patients will undergo a 10 ml blood draw for PRP preparation and a 3 ml
peripheral blood draw for a complete blood count with leukocyte differential. This will be
performed on patients who received HA to maintain patient blinding and to characterize the
peripheral white blood cells (WBC) and platelet counts. A complete blood count (CBC) will be
completed on PRP prior to injection to evaluate the fold increase in platelet concentration
and to confirm rarity of red white blood cells. A synovial fluid aspirate of approximately
2cc will be performed under ultrasound guidance just prior to each PRP or HA injection for
ELISA analysis of basal and post-treatment intra-articular environment. After treatment,
patients will be instructed to limit the use of the leg for at least 24 hours and use cold
therapy/icing for discomfort. During this treatment period rest or mild exertion activities
(such as exercise bike, aquatic therapy) are recommended, followed by gradual return to
sports or recreational activities as tolerated.
effects of PRP to HA in patients with mild to moderate OA using biologic and clinical
correlates of outcomes associated with the treatment of OA. The investigators will test the
null hypothesis that there are no differences in clinical outcomes as measured by validated
clinical scoring systems for OA, nor is there any difference in intra-articular biology
between groups of patients treated with HA and those treated with PRP over time.
This study was a prospective, randomized, double blind, comparative clinical trial with an
allocation ratio of 1:1 that underwent IRB approval at the principal institution. Between
2011 and 2014 patients will be screened for participation. All comers with a diagnosis of
osteoarthritis of the knee between 18 and 80 years of age will be screened.
Treatment and Evaluation Patients who meet inclusion criteria will be randomized via an
electronic randomization process into two groups: one receiving intra-articular PRP and the
other, intra-articular HA. Non-clinical staff will perform randomization, clinical staff
performed the injections, and results and analyses will be performed by the primary research
team. Patients and the primary research team performing analysis will be blinded to
assignments. All patients will undergo a 10 ml blood draw for PRP preparation and a 3 ml
peripheral blood draw for a complete blood count with leukocyte differential. This will be
performed on patients who received HA to maintain patient blinding and to characterize the
peripheral white blood cells (WBC) and platelet counts. A complete blood count (CBC) will be
completed on PRP prior to injection to evaluate the fold increase in platelet concentration
and to confirm rarity of red white blood cells. A synovial fluid aspirate of approximately
2cc will be performed under ultrasound guidance just prior to each PRP or HA injection for
ELISA analysis of basal and post-treatment intra-articular environment. After treatment,
patients will be instructed to limit the use of the leg for at least 24 hours and use cold
therapy/icing for discomfort. During this treatment period rest or mild exertion activities
(such as exercise bike, aquatic therapy) are recommended, followed by gradual return to
sports or recreational activities as tolerated.
Inclusion Criteria:
- 18-80 years old
- Mild to moderate unilateral, symptomatic osteoarthritis of the knee
- No recent (within 3 months) intra-articular intervention to the affected knee
Exclusion Criteria:
- Knee instability
- Varus/Valgus alignment >5 degrees
- Bilateral knee osteoarthritis
- Systemic inflammatory arthropathy
- Known history of anemia, coagulopathy, or present use of blood thinners
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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