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CompletedNCT02239029Updated Dec 6, 2016

Platelet Rich Plasma on Osteoarthritis of Knee

An interventional study of platelet rich plasma and Normal saline in Knee Osteoarthritis, sponsored by Yung-Tsan Wu. Completed at 1 site in Taiwan. Open to participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-12-06.

Sponsored by Yung-Tsan Wu · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
35 Years to 75 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Knee Osteoarthritis

Keywords

  • Platelet rich plasma
  • Osteoarthritis of knee
  • Balance
  • Strength
03

In context

Osteoarthritis

4,397 studies on the registry are indexed under Osteoarthritis; 581 are open to participants now.

This study's enrollment of 20 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Yung-Tsan Wu is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
35 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    Platelet rich plasma

    Platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders. Patients with bilaetral knee osteoarthritis randomized receive on dose of PRP in one knee and placebo with normal saline in the other side.

    Drug: platelet rich plasma

  • Placebo comparator
    normal saline

    Normal saline was injected into the other side of knee as the control group.

    Drug: Normal saline

Interventions

  • Drugplatelet rich plasma

    Platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders.

  • DrugNormal saline

    The normal salin as the placebo intervention was injection in the other side of knee.

06

What researchers measure

Primary outcomes

  1. Change from baseline of pain on 2nd week, 1st month, 3rd month and 6th month after PRP.

    Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.

    Time frame: Pre-treatment, 2nd week, 1st month, 3rd month and 6th month after PRP.

Secondary outcomes

  1. Change from baseline in severity of symptoms and functional status on 2nd week, 1st month, 3rd month and 6th month after treatment.

    Using the Lequesne's severity index to measure the symptoms and functional status before treatment and multiple time frame after treatment.

    Time frame: Pre-treatment, on 2nd week, 1st month, 3rd month and 6th month after treatment..

  2. Change from baseline in severity of symptoms and functional status on 2nd week, 1st month, 3rd month and 6th month after treatment.

    Using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) to measure the symptoms and functional status before treatment and multiple time frame after treatment.

    Time frame: Pre-treatment and 2nd week, 1st month, 3rd month and 6th month after treatment.

  3. Change from baseline in balance function on 2nd week, 1st month, 3rd month and 6th month after treatment.

    Using the balance test (Biodex) to measure the balance function before treatment and multiple time frame after treatment.

    Time frame: Pre-treatment, 2nd week, 1st month, 3rd month and 6th month after treatment.

  4. Change from baseline in muscle strength of lower extremities on 2nd week, 1st month, 3rd month and 6th month after treatment.

    Using the isokinetic strengthening test to measure the muscle strength of lower extremities before treatment and multiple time frame after treatment.

    Time frame: Pre-treatment, 2nd week, 1st month, 3rd month and 6th month after treatment.

07

Study locations

1 site
  • Tri-Service General Hospital, National Defense Medical Center,
    Taipei, Neihu District 886, Taiwan
08

References and documents

Publications

  • 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. PubMed 22241605 ↗
  • 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. PubMed 23299850 ↗
  • 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. PubMed 22513879 ↗
  • 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. PubMed 24642715 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02239029
Lead sponsor
Yung-Tsan Wu
Responsible party
Yung-Tsan Wu (Attending Physician, Tri-Service General Hospital) — Sponsor-investigator
First posted
Sep 12, 2014
Start date
Aug 2014
Primary completion
Oct 2016
Completion
Oct 2016
Last update
Dec 6, 2016

Study contacts

Liang-Cheng Chen, MD, MS
principal investigator · Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, National Defense Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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