Platelet Rich Plasma vs Hyaluronic-Acid in Hip OA (Osteoarthritis)
NCT01920152 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38
Last updated 2021-03-03
Summary
The objective of this study is to compare the clinical efficacy of intra-articular injections of autologous platelet rich plasma (PRP) vs hyaluronic acid (HA) for symptomatic early osteoarthritis (OA) of the hip. Secondarily, this study aims to determine the feasibility and safety of treating early OA of the hip with HA and PRP.
Conditions
- Hip Osteoarthritis
Interventions
- BIOLOGICAL
-
PRP
Each PRP preparation requires a total of 36 ml of peripheral blood. This will be obtained via venapuncture and collected in four 9 ml extraction tubes containing 3.8% sodium citrate. The tubes are then centrifuged at 640 rpm for 8 minutes at room temperature. The 1ml plasma fraction located above the buffy coat is aspirated from each tube and dispensed into the fractioning tube. The entire PRP process takes place under laminar airflow. Immediately prior to injection, calcium chloride is is drawn up from the activator ampoule with the activation syringe and is added to the PRP fractioning tube. The activated PRP is then injected in its entirety into the hip joint under strict aseptic technique.
- DEVICE
-
Hyaluronic Acid
Hyaluronic acid is supplied as a non-pyrogenic solution in 2.5 ml pre-filled syringes and is administered by intra-articular injection using a 22-23 gauge needle. The full 2.5 ml is injected in one joint under strict aseptic administration.
Sponsors & Collaborators
-
University of Colorado, Denver
lead OTHER
Principal Investigators
-
Omer Mei-Dan, MD · University of Colorado, Denver
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 30 Years
- Max Age
- 72 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-08-31
- Primary Completion
- 2019-12-05
- Completion
- 2019-12-05
Countries
- United States
Study Locations
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