Clinical trial NCT03290365: The Combination Effect of Platelet-rich Plasma and Hyaluronic Acid for Knee Osteoarthritis
Official title: The Combination Long-term Effect of Platelet-rich Plasma and Hyaluronic Acid in Patients With Knee Osteoarthritis: a Prospective Randomized Double-blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Platelet rich plasma
Osteoarthritis of knee
Hyaluronic acid
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2017-09-21
Enrollment: 46
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although platelet rich plasma (PRP) and Hyaluronic acid (HA) are beneficial for osteoarthritis of knee (OA knee), the combined effect of PRP with HA was not clear so far. Hence, investigator assess a prospective randomized double-blind controlled trial.

Detailed description: Patients with single or bilateral OA knee will be enrolled and randomized into intervention and control group. One dose of PRP is applied into both groups. One week later, one dose of HA is injected in intervention group and one dose of normal saline is injected in control group. Outcome measurements included visual analog scale (VAS)、Lequesne's severity index、Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)、balance test (Biodex) and analysis of synovial fluid at different follow-up frame (1st month, 3rd month, 6th month and 1 year after treatment).

Eligibility criteria: Inclusion Criteria:

1. Age between 50 to 75 y/o.
2. Alert consciousness
3. Symptom of knee osteoarthritis persist at least 6 months and stage I to III scored by Ahlbäck grading system
4. The pain score measured by VAS at least 4 points

Exclusion Criteria:

1. Has received hyaluronic acid, PRP or steroid injection within 6 months
2. Has received NSAIDs or steroid within one week
3. Tumor or metastasis surrounding the knee joint
4. Has received total knee replacement, major surgery in knee, rheumatoid arthritis
5. Patient who cant tolerance the balance test.
6. Thrombocytopenia or coagulopathy

Primary outcomes:
measure: Change from baseline in severity of symptoms and functional status on 1st month, 3rd month, 6th month and one year after injection.
timeFrame: Pre-treatment, 1st month, 3rd month, 6th month and one year after injection.
Secondary outcomes:
measure: Change from baseline in severity of symptoms and functional status on 1st month, 3rd month, 6th month and one year after injection.
timeFrame: Pre-treatment, 1st month, 3rd month, 6th month and one year after injection.
measure: Change from baseline of pain on 1st month, 3rd month, 6th month and one year after injection.
timeFrame: Pre-treatment, 1st month, 3rd month, 6th month and one year after injection.
measure: Change from baseline in balance function on 1st month, 3rd month, 6th month and one year after injection.
timeFrame: Pre-treatment, 1st month, 3rd month, 6th month and one year after injection.
measure: Change from baseline in analysis of synovial fluid on 6th month and one year after injection.
timeFrame: Pre-treatment, 6th month and one year after injection.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
state: Neihu District
Study officials:
affiliation: Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, National Defense Medical Center
name: Yung-Tsan Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abate M, Verna S, Schiavone C, Di Gregorio P, Salini V. Efficacy and safety profile of a compound composed of platelet-rich plasma and hyaluronic acid in the treatment for knee osteoarthritis (preliminary results). Eur J Orthop Surg Traumatol. 2015 Dec;25(8):1321-6. doi: 10.1007/s00590-015-1693-3. Epub 2015 Sep 24.
citation: Lana JF, Weglein A, Sampson SE, Vicente EF, Huber SC, Souza CV, Ambach MA, Vincent H, Urban-Paffaro A, Onodera CM, Annichino-Bizzacchi JM, Santana MH, Belangero WD. Randomized controlled trial comparing hyaluronic acid, platelet-rich plasma and the combination of both in the treatment of mild and moderate osteoarthritis of the knee. J Stem Cells Regen Med. 2016 Nov 29;12(2):69-78. doi: 10.46582/jsrm.1202011. eCollection 2016.
citation: Chen SH, Kuan TS, Kao MJ, Wu WT, Chou LW. Clinical effectiveness in severe knee osteoarthritis after intra-articular platelet-rich plasma therapy in association with hyaluronic acid injection: three case reports. Clin Interv Aging. 2016 Sep 8;11:1213-1219. doi: 10.2147/CIA.S114795. eCollection 2016.
citation: Dallari D, Stagni C, Rani N, Sabbioni G, Pelotti P, Torricelli P, Tschon M, Giavaresi G. Ultrasound-Guided Injection of Platelet-Rich Plasma and Hyaluronic Acid, Separately and in Combination, for Hip Osteoarthritis: A Randomized Controlled Study. Am J Sports Med. 2016 Mar;44(3):664-71. doi: 10.1177/0363546515620383. Epub 2016 Jan 21.