Platelet Rich Plasma on Osteoarthritis of Knee

Knee Osteoarthritis Clinical Trial

Official title:

The Effect of Platelet Rich Plasma on Osteoarthritis of Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02239029
• Other study ID #: TSGHIRB-2-103-05-075
• Secondary ID: TSGHIRB-2-103-05
• Status: Completed
• Phase: N/A
• First received: September 10, 2014
• Last updated: December 4, 2016
• Start date: August 2014
• Est. completion date: October 2016

Study information

• Verified date: December 2016
• Source: Tri-Service General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• platelet rich plasma
Platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders.
• Normal saline
The normal salin as the placebo intervention was injection in the other side of knee.

Locations

Country	Name	City	State
Taiwan	Tri-Service General Hospital, National Defense Medical Center,	Taipei	Neihu District

Sponsors (1)

Lead Sponsor	Collaborator
Yung-Tsan Wu

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

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. — View 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: — View 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: 10.1177/03635465124 — View Citation

Spaková T, Rosocha J, Lacko M, Harvanová 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Pre-treatment, 2nd week, 1st month, 3rd month and 6th month after PRP.	Yes
Secondary	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.	Pre-treatment, on 2nd week, 1st month, 3rd month and 6th month after treatment..	Yes
Secondary	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.	Pre-treatment and 2nd week, 1st month, 3rd month and 6th month after treatment.	Yes
Secondary	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.	Pre-treatment, 2nd week, 1st month, 3rd month and 6th month after treatment.	Yes
Secondary	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.	Pre-treatment, 2nd week, 1st month, 3rd month and 6th month after treatment.	Yes