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NCT Number: NCT02239029

Platelet Rich Plasma on Osteoarthritis of Knee

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tri-Service General Hospital, National Defense Medical Center,

Taipei, Neihu District, 886, Taiwan

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Has received hyaluronic acid or steroid injection within 6 monts
  • Has received NSAIDs or steroid within one week
  • Tumor or metastasis surrounding the knee joint
  • Has received total knee replacement, major surgery in knee, rheumatoid arthritis
  • Patient who cant tolerance the balance or muscle strength test.

Treatment and study plan

Platelet rich plasma

Drug

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

normal saline

Drug

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

Primary outcomes

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

    Time frame: Pre-treatment, 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.

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.

    Time frame: Pre-treatment, 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.

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

    Time frame: Pre-treatment and 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.

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

    Time frame: Pre-treatment, 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.

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

    Time frame: Pre-treatment, 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.

Sponsors and collaborators

Lead sponsor

Yung-Tsan Wu

Other

Registry information

Official study title

The Effect of Platelet Rich Plasma on Osteoarthritis of Knee

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 12, 2014
Registry last updated
Dec 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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