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CompletedNCT03290365Updated Jul 13, 2021

The Combination Effect of Platelet-rich Plasma and Hyaluronic Acid for Knee Osteoarthritis

An interventional study of platelet rich plasma + Hyaluronic acid and platelet rich plasma + normal saline in Knee Osteoarthritis, sponsored by Tri-Service General Hospital. Completed at 1 site in Taiwan. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-07-13.

Sponsored by Tri-Service General Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
50 Years to 75 Years
Sex
All
01

Study summary

Although platelet rich plasma (PRP) and Hyaluronic acid (HA) are beneficial for osteoarthritis of knee (OA knee), the combined effect of PRP with HA was not clear so far. Hence, investigator assess a prospective randomized double-blind controlled trial.

Read the detailed description

Patients with single or bilateral OA knee will be enrolled and randomized into intervention and control group. One dose of PRP is applied into both groups. One week later, one dose of HA is injected in intervention group and one dose of normal saline is injected in control group. Outcome measurements included visual analog scale (VAS)、Lequesne's severity index、Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)、balance test (Biodex) and analysis of synovial fluid at different follow-up frame (1st month, 3rd month, 6th month and 1 year after treatment).

02

Conditions studied

  • Knee Osteoarthritis

Keywords

  • Platelet rich plasma
  • Osteoarthritis of knee
  • Hyaluronic acid
03

Who can participate

Ages eligible
50 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age between 50 to 75 y/o.
  2. Alert consciousness
  3. Symptom of knee osteoarthritis persist at least 6 months and stage I to III scored by Ahlbäck grading system
  4. The pain score measured by VAS at least 4 points

Exclusion criteria

Exclusion Criteria:

  1. Has received hyaluronic acid, PRP or steroid injection within 6 months
  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 test.
  6. Thrombocytopenia or coagulopathy
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
46 participants (actual)

Study arms

  • Active comparator
    Platelet rich plasma + Hyaluronic acid

    Platelet rich plasma (PRP) and Hyaluronic acid (HA) are beneficial for patients with osteoarthritis of knee. Patients received one dose of PRP injection. One week later, the one dose of HA is injected for intervention group.

    Drug: platelet rich plasma + Hyaluronic acid

  • Placebo comparator
    Platelet rich plasma + normal saline

    Patients received one dose of PRP injection. One week later, the one dose of normal saline is injected for control group.

    Drug: platelet rich plasma + normal saline

Interventions

  • Drugplatelet rich plasma + Hyaluronic acid

    Platelet rich plasma (PRP) and Hyaluronic acid (HA) are beneficial for patients with osteoarthritis of knee.

  • Drugplatelet rich plasma + normal saline

    The normal salin as the placebo intervention was injection control group.

05

What researchers measure

Primary outcomes

  1. Change from baseline in severity of symptoms and functional status on 1st month, 3rd month, 6th month and one year after injection.

    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. Both subscales has the scores ranged from 1 to 5 for each item and a higher score indicating more severe of symptom or impaired functional status.

    Time frame: Pre-treatment, 1st month, 3rd month, 6th month and one year after injection.

Secondary outcomes

  1. Change from baseline in severity of symptoms and functional status on 1st month, 3rd month, 6th month and one year after injection.

    Using the Lequesne's severity index to measure the symptoms and functional status before treatment and multiple time frame after treatment. A higher score indicate more severe.

    Time frame: Pre-treatment, 1st month, 3rd month, 6th month and one year after injection.

  2. Change from baseline of pain on 1st month, 3rd month, 6th month and one year after injection.

    Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment. The score ranging from 10 (remarkable pain) to 0 (no pain).

    Time frame: Pre-treatment, 1st month, 3rd month, 6th month and one year after injection.

  3. Change from baseline in balance function on 1st month, 3rd month, 6th month and one year after injection.

    Using the balance test (Biodex) to measure the balance function before treatment and multiple time frame after treatment.

    Time frame: Pre-treatment, 1st month, 3rd month, 6th month and one year after injection.

  4. Change from baseline in analysis of synovial fluid on 6th month and one year after injection.

    The synovial fluid is aspirated to measure the parameters before treatment and multiple time frame after treatment.

    Time frame: Pre-treatment, 6th month and one year after injection.

06

Study locations

1 site
  • Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
    Taipei, Neihu District 886, Taiwan
07

References and documents

Publications

  • Abate M, Verna S, Schiavone C, Di Gregorio P, Salini V. Efficacy and safety profile of a compound composed of platelet-rich plasma and hyaluronic acid in the treatment for knee osteoarthritis (preliminary results). Eur J Orthop Surg Traumatol. 2015 Dec;25(8):1321-6. doi: 10.1007/s00590-015-1693-3. Epub 2015 Sep 24. PubMed 26403468 ↗
  • Lana JF, Weglein A, Sampson SE, Vicente EF, Huber SC, Souza CV, Ambach MA, Vincent H, Urban-Paffaro A, Onodera CM, Annichino-Bizzacchi JM, Santana MH, Belangero WD. Randomized controlled trial comparing hyaluronic acid, platelet-rich plasma and the combination of both in the treatment of mild and moderate osteoarthritis of the knee. J Stem Cells Regen Med. 2016 Nov 29;12(2):69-78. doi: 10.46582/jsrm.1202011. eCollection 2016. PubMed 28096631 ↗
  • Chen SH, Kuan TS, Kao MJ, Wu WT, Chou LW. Clinical effectiveness in severe knee osteoarthritis after intra-articular platelet-rich plasma therapy in association with hyaluronic acid injection: three case reports. Clin Interv Aging. 2016 Sep 8;11:1213-1219. doi: 10.2147/CIA.S114795. eCollection 2016. PubMed 27660427 ↗
  • Dallari D, Stagni C, Rani N, Sabbioni G, Pelotti P, Torricelli P, Tschon M, Giavaresi G. Ultrasound-Guided Injection of Platelet-Rich Plasma and Hyaluronic Acid, Separately and in Combination, for Hip Osteoarthritis: A Randomized Controlled Study. Am J Sports Med. 2016 Mar;44(3):664-71. doi: 10.1177/0363546515620383. Epub 2016 Jan 21. PubMed 26797697 ↗
08

Registry details

Key details

Study ID
NCT03290365
Lead sponsor
Tri-Service General Hospital
Responsible party
Yung-Tsan Wu (Attending Physician, Tri-Service General Hospital) — Principal investigator
First posted
Sep 21, 2017
Start date
Jan 10, 2018
Primary completion
Jul 1, 2021
Completion
Jul 1, 2021
Last update
Jul 13, 2021

Study contacts

Yung-Tsan Wu, MD
principal investigator · Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, National Defense Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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