Platelet Rich Plasma on Osteoarthritis of Knee

NCT02239029 | Completed DMC

• 2 other identifiers: TSGHIRB-2-103-05-075TSGHIRB-2-103-05-075, Taiwan
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Platelet rich plasma; Osteoarthritis of knee; Balance; Strength

Outcome Measures

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.

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

Secondary Outcomes (4)

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

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

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

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

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

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

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

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

Study Arms (2)

Platelet rich plasma

ACTIVE COMPARATOR

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

normal saline

PLACEBO COMPARATOR

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

Drug: Normal saline

Interventions

platelet rich plasma DRUG

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

Platelet rich plasma

Normal saline DRUG

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

normal saline

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yung-Tsan Wu: lead

Study Sites (1)

Tri-Service General Hospital, National Defense Medical Center,

Taipei, Neihu District, 886, Taiwan

Location

Related Publications (4)

• 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.

  PMID: 22241605 RESULT

• 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.

  PMID: 23299850 RESULT

• 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.

  PMID: 22513879 RESULT

• 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.

  PMID: 24642715 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Liang-Cheng Chen, MD, MS

  Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, National Defense Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: September 10, 2014
• First Posted: September 12, 2014
• Study Start: August 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: December 6, 2016

Record last verified: 2016-12

Locations

TW (1)