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Platelet Rich Plasma on Osteoarthritis of Knee

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
platelet rich plasma
Normal saline
Sponsored by
Yung-Tsan Wu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Platelet rich plasma, Osteoarthritis of knee, Balance, Strength

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tri-Service General Hospital, National Defense Medical Center,

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Platelet rich plasma

normal saline

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
September 10, 2014
Last Updated
December 4, 2016
Sponsor
Yung-Tsan Wu
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1. Study Identification

Unique Protocol Identification Number
NCT02239029
Brief Title
Platelet Rich Plasma on Osteoarthritis of Knee
Official Title
The Effect of Platelet Rich Plasma on Osteoarthritis of Knee
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yung-Tsan Wu

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Platelet rich plasma, Osteoarthritis of knee, Balance, Strength

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Platelet rich plasma
Arm Type
Active Comparator
Arm Description
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.
Arm Title
normal saline
Arm Type
Placebo Comparator
Arm Description
Normal saline was injected into the other side of knee as the control group.
Intervention Type
Drug
Intervention Name(s)
platelet rich plasma
Intervention Description
Platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
The normal salin as the placebo intervention was injection in the other side of knee.
Primary Outcome Measure Information:
Title
Change from baseline of pain on 2nd week, 1st month, 3rd month and 6th month after PRP.
Description
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 Outcome Measure Information:
Title
Change from baseline in severity of symptoms and functional status on 2nd week, 1st month, 3rd month and 6th month after treatment.
Description
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..
Title
Change from baseline in severity of symptoms and functional status on 2nd week, 1st month, 3rd month and 6th month after treatment.
Description
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.
Title
Change from baseline in balance function on 2nd week, 1st month, 3rd month and 6th month after treatment.
Description
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.
Title
Change from baseline in muscle strength of lower extremities on 2nd week, 1st month, 3rd month and 6th month after treatment.
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liang-Cheng Chen, MD, MS
Organizational Affiliation
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, National Defense Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tri-Service General Hospital, National Defense Medical Center,
City
Taipei
State/Province
Neihu District
ZIP/Postal Code
886
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
22241605
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.
Results Reference
result
PubMed Identifier
23299850
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.
Results Reference
result
PubMed Identifier
22513879
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.
Results Reference
result
PubMed Identifier
24642715
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.
Results Reference
result

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Platelet Rich Plasma on Osteoarthritis of Knee

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