Clinical trial NCT02239029: Platelet Rich Plasma on Osteoarthritis of Knee
Official title: The Effect of Platelet Rich Plasma on Osteoarthritis of Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Platelet rich plasma
Osteoarthritis of knee
Balance
Strength
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2014-09-12
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although few studies have showed beneficial effect of platelet rich plasma (PRP) for osteoarthritis of knee (OA knee), only one study applied randomized, control method and none of them has the objective measurements such as balance test or muscle strength which were reported as decrease in patients with OA knees. We assess the analgesic effect and the extent of improved muscle strength and balance after PRP in patients with OA knee.

Detailed description: Patients with bilateral OA knee will be enrolled and randomized into intervention and control knee. One dose of PRP is applied in the intervention knee and normal saline in control side. Outcome measurements included visual analog scale (VAS)、Lequesne's severity index、Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)、balance test (Biodex) and isokinetic strengthening test at different follow-up frame (2nd week, 1st month, 3rd month and 6th month after treatment).

Eligibility criteria: Inclusion Criteria:

1. Age between 35 to 75 y/o.
2. Alert consciousness
3. Symptom of knee osteoarthritis persist at least 6 months and stage I or II scored by Ahlbäck grading system
4. The pain score measured by VAS at least 4 points

Exclusion Criteria:

1. Has received hyaluronic acid or steroid injection within 6 monts
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 or muscle strength test.

Primary outcomes:
measure: Change from baseline of pain on 2nd week, 1st month, 3rd month and 6th month after PRP.
timeFrame: Pre-treatment, 2nd week, 1st month, 3rd month and 6th month after PRP.
Secondary outcomes:
measure: Change from baseline in severity of symptoms and functional status on 2nd week, 1st month, 3rd month and 6th month after treatment.
timeFrame: Pre-treatment, on 2nd week, 1st month, 3rd month and 6th month after treatment..
measure: Change from baseline in severity of symptoms and functional status on 2nd week, 1st month, 3rd month and 6th month after treatment.
timeFrame: Pre-treatment and 2nd week, 1st month, 3rd month and 6th month after treatment.
measure: Change from baseline in balance function on 2nd week, 1st month, 3rd month and 6th month after treatment.
timeFrame: Pre-treatment, 2nd week, 1st month, 3rd month and 6th month after treatment.
measure: Change from baseline in muscle strength of lower extremities on 2nd week, 1st month, 3rd month and 6th month after treatment.
timeFrame: Pre-treatment, 2nd week, 1st month, 3rd month and 6th month after treatment.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital, National Defense Medical Center,
state: Neihu District
Study officials:
affiliation: Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, National Defense Medical Center
name: Liang-Cheng Chen, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Matava MJ. Platelet-rich plasma: the next big thing?: commentary on an article by Ujash Sheth, BHSc, et al.: "Efficacy of autologous platelet-rich plasma use for orthopaedic indications: a meta-analysis". J Bone Joint Surg Am. 2012 Feb 15;94(4):e25. doi: 10.2106/JBJS.K.01423. No abstract available.
citation: Patel S, Dhillon MS, Aggarwal S, Marwaha N, Jain A. Treatment with platelet-rich plasma is more effective than placebo for knee osteoarthritis: a prospective, double-blind, randomized trial. Am J Sports Med. 2013 Feb;41(2):356-64. doi: 10.1177/0363546512471299. Epub 2013 Jan 8.
citation: Spakova T, Rosocha J, Lacko M, Harvanova D, Gharaibeh A. Treatment of knee joint osteoarthritis with autologous platelet-rich plasma in comparison with hyaluronic acid. Am J Phys Med Rehabil. 2012 May;91(5):411-7. doi: 10.1097/PHM.0b013e3182aab72.
citation: Khalaj N, Abu Osman NA, Mokhtar AH, Mehdikhani M, Wan Abas WA. Balance and risk of fall in individuals with bilateral mild and moderate knee osteoarthritis. PLoS One. 2014 Mar 18;9(3):e92270. doi: 10.1371/journal.pone.0092270. eCollection 2014.