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The Role of Synovitis in Osteoarthritis

Primary Purpose

Synovitis of Knee, Osteoarthritis, Knee

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
platelet rich plasma
Hyaluronic acid
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Synovitis of Knee

Eligibility Criteria

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

Inclusion Criteria:

  • diagnosed with OA knee according to ACR guideline

    1. stiffness less than 30min
    2. cracking sound during activity
    3. more than 30min pain for last 2 months
    4. non-bed ridden patients
    5. no structure abnormality
    6. synovitis was proved by US

Exclusion Criteria:

1. OA knee secondary to other disease 2 . more than 10 years after diagnosing OA 3. under knee surgery within 3 months 4. autoimmune disease 5. refuses inform/consent process

Sites / Locations

  • Taipei veteran general hospital yuli branchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PRP group

HA group

Arm Description

the patients received PRP(platelet-rich-plasma) injection twice at 2-week intervals

the patients received HA(hyaluronic acid) injection twice at 2-week intervals

Outcomes

Primary Outcome Measures

visual analog scale(VAS)
visual analog scale(VAS)
visual analog scale(VAS)
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index)
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index)
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index)

Secondary Outcome Measures

Imaging evaluation based on color Doppler ultrasound(CDUS) and the depth of synovial fluid accumulation ,and the width of synovial hypertrophy was performed simultaneously.
Imaging evaluation based on color Doppler ultrasound(CDUS) and the depth of synovial fluid accumulation ,and the width of synovial hypertrophy was performed
Imaging evaluation based on color Doppler ultrasound(CDUS) and the depth of synovial fluid accumulation ,and the width of synovial hypertrophy was performed

Full Information

First Posted
May 18, 2017
Last Updated
February 9, 2020
Sponsor
Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT03167333
Brief Title
The Role of Synovitis in Osteoarthritis
Official Title
Does Synovitis Affect Treatment Efficacy in Intra-articular Injection Therapy to Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Anticipated)
Primary Completion Date
March 1, 2020 (Anticipated)
Study Completion Date
March 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To determine whether platelet-rich-plasma (PRP) or HA (hyaluronic acid)injection into synovitis in osteoarthritis(OA) knee can achieve improvement in knee function and reduce synovitis.
Detailed Description
Methods: sixty patients with OA knee having unilateral or bilateral synovitis validated by ultrasound (N=40) were studied. All the patients were randomized to receive PRP (N=40) or Hyaluronic acid(HA)(N=40) injection twice at 2-week intervals; Clinical assessments were performed using a visual analog scale(VAS) and The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index) before injection at baseline, 4 weeks(first evaluation) and 12 weeks(secondary evaluation). Imaging evaluation based on color Doppler ultrasound(CDUS) and the depth of synovial fluid accumulation ,and the width of synovial hypertrophy was performed simultaneously.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Synovitis of Knee, Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PRP group
Arm Type
Experimental
Arm Description
the patients received PRP(platelet-rich-plasma) injection twice at 2-week intervals
Arm Title
HA group
Arm Type
Active Comparator
Arm Description
the patients received HA(hyaluronic acid) injection twice at 2-week intervals
Intervention Type
Drug
Intervention Name(s)
platelet rich plasma
Intervention Description
The amount of PPR was about 4-5 cc
Intervention Type
Drug
Intervention Name(s)
Hyaluronic acid
Intervention Description
HA was 2.5cc
Primary Outcome Measure Information:
Title
visual analog scale(VAS)
Time Frame
before injection at baseline
Title
visual analog scale(VAS)
Time Frame
4 weeks(first evaluation)
Title
visual analog scale(VAS)
Time Frame
12 weeks(secondary evaluation)
Title
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index)
Time Frame
before injection at baseline
Title
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index)
Time Frame
4 weeks(first evaluation)
Title
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index)
Time Frame
12 weeks(secondary evaluation)
Secondary Outcome Measure Information:
Title
Imaging evaluation based on color Doppler ultrasound(CDUS) and the depth of synovial fluid accumulation ,and the width of synovial hypertrophy was performed simultaneously.
Time Frame
before injection at baseline
Title
Imaging evaluation based on color Doppler ultrasound(CDUS) and the depth of synovial fluid accumulation ,and the width of synovial hypertrophy was performed
Time Frame
4 weeks(first evaluation)
Title
Imaging evaluation based on color Doppler ultrasound(CDUS) and the depth of synovial fluid accumulation ,and the width of synovial hypertrophy was performed
Time Frame
12 weeks(secondary evaluation)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosed with OA knee according to ACR guideline stiffness less than 30min cracking sound during activity more than 30min pain for last 2 months non-bed ridden patients no structure abnormality synovitis was proved by US Exclusion Criteria: 1. OA knee secondary to other disease 2 . more than 10 years after diagnosing OA 3. under knee surgery within 3 months 4. autoimmune disease 5. refuses inform/consent process
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chien-CHIh Wang, MD
Phone
886-958738258
Email
candycandywang@gmail.com
Facility Information:
Facility Name
Taipei veteran general hospital yuli branch
City
Hualien City
ZIP/Postal Code
886
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chien-Chih Wang
Phone
886 958738258
Email
candycandywang@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Role of Synovitis in Osteoarthritis

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