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

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
platelet rich plasma + Hyaluronic acid
platelet rich plasma + normal saline
Sponsored by
Tri-Service General Hospital
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, Hyaluronic acid

Eligibility Criteria

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

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:

  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

Sites / Locations

  • Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Platelet rich plasma + Hyaluronic acid

Platelet rich plasma + normal saline

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
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.
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.

Full Information

First Posted
September 19, 2017
Last Updated
July 10, 2021
Sponsor
Tri-Service General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03290365
Brief Title
The Combination Effect of Platelet-rich Plasma and Hyaluronic Acid for Knee Osteoarthritis
Official Title
The Combination Long-term Effect of Platelet-rich Plasma and Hyaluronic Acid in Patients With Knee Osteoarthritis: a Prospective Randomized Double-blind Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tri-Service General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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).

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, Hyaluronic acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Platelet rich plasma + Hyaluronic acid
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Platelet rich plasma + normal saline
Arm Type
Placebo Comparator
Arm Description
Patients received one dose of PRP injection. One week later, the one dose of normal saline is injected for control group.
Intervention Type
Drug
Intervention Name(s)
platelet rich plasma + Hyaluronic acid
Intervention Description
Platelet rich plasma (PRP) and Hyaluronic acid (HA) are beneficial for patients with osteoarthritis of knee.
Intervention Type
Drug
Intervention Name(s)
platelet rich plasma + normal saline
Intervention Description
The normal salin as the placebo intervention was injection control group.
Primary Outcome Measure Information:
Title
Change from baseline in severity of symptoms and functional status on 1st month, 3rd month, 6th month and one year after injection.
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. 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 Outcome Measure Information:
Title
Change from baseline in severity of symptoms and functional status on 1st month, 3rd month, 6th month and one year after injection.
Description
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.
Title
Change from baseline of pain on 1st month, 3rd month, 6th month and one year after injection.
Description
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.
Title
Change from baseline in balance function on 1st month, 3rd month, 6th month and one year after injection.
Description
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.
Title
Change from baseline in analysis of synovial fluid on 6th month and one year after injection.
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 50 to 75 y/o. Alert consciousness Symptom of knee osteoarthritis persist at least 6 months and stage I to III scored by Ahlbäck grading system The pain score measured by VAS at least 4 points Exclusion Criteria: Has received hyaluronic acid, PRP or steroid injection within 6 months 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 test. Thrombocytopenia or coagulopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yung-Tsan Wu, MD
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
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
City
Taipei
State/Province
Neihu District
ZIP/Postal Code
886
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
26403468
Citation
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.
Results Reference
result
PubMed Identifier
28096631
Citation
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.
Results Reference
result
PubMed Identifier
27660427
Citation
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.
Results Reference
result
PubMed Identifier
26797697
Citation
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.
Results Reference
result

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

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