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Platelet Rich Plasma on Osteoarthritis of Knee

NCT ID: NCT02239029

Last Updated: 2016-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-10-31

Brief Summary

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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

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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).

Conditions

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Knee Osteoarthritis

Keywords

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Platelet rich plasma Osteoarthritis of knee Balance Strength

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

platelet rich plasma

Intervention Type DRUG

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

normal saline

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

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

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

Interventions

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platelet rich plasma

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

Intervention Type DRUG

Normal saline

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yung-Tsan Wu

OTHER

Sponsor Role lead

Responsible Party

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Yung-Tsan Wu

Attending Physician

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Liang-Cheng Chen, MD, MS

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Tri-Service General Hospital, National Defense Medical Center,

Taipei, Neihu District, Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type RESULT
PMID: 22241605 (View on PubMed)

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.

Reference Type RESULT
PMID: 23299850 (View on PubMed)

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.

Reference Type RESULT
PMID: 22513879 (View on PubMed)

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.

Reference Type RESULT
PMID: 24642715 (View on PubMed)

Other Identifiers

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TSGHIRB-2-103-05-075, Taiwan

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

TSGHIRB-2-103-05-075

Identifier Type: -

Identifier Source: org_study_id