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Status unknownNCT03167333Updated Feb 11, 2020

The Role of Synovitis in Osteoarthritis

An interventional study of platelet rich plasma and Hyaluronic acid in Synovitis of Knee and Osteoarthritis, Knee, sponsored by Taipei Veterans General Hospital, Taiwan. Status unknown at 1 site in Taiwan. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-02-11.

Sponsored by Taipei Veterans General Hospital, Taiwan · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
45 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Synovitis of Knee
  • Osteoarthritis, Knee
03

Who can participate

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

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    PRP group

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

    Drug: platelet rich plasma

  • Active comparator
    HA group

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

    Drug: Hyaluronic acid

Interventions

  • Drugplatelet rich plasma

    The amount of PPR was about 4-5 cc

  • DrugHyaluronic acid

    HA was 2.5cc

05

What researchers measure

Primary outcomes

  1. visual analog scale(VAS)

    Time frame: before injection at baseline

  2. visual analog scale(VAS)

    Time frame: 4 weeks(first evaluation)

  3. visual analog scale(VAS)

    Time frame: 12 weeks(secondary evaluation)

  4. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index)

    Time frame: before injection at baseline

  5. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index)

    Time frame: 4 weeks(first evaluation)

  6. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index)

    Time frame: 12 weeks(secondary evaluation)

Secondary outcomes

  1. 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

  2. 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)

  3. 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)

06

Study locations

1 of 1 sites recruiting
  • Taipei veteran general hospital yuli branch
    Hualien City, 886, Taiwan
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03167333
Lead sponsor
Taipei Veterans General Hospital, Taiwan
Responsible party
Sponsor
First posted
May 25, 2017
Start date
Mar 1, 2020 (estimated)
Primary completion
Mar 1, 2020 (estimated)
Completion
Mar 1, 2020 (estimated)
Last update
Feb 11, 2020

Study contacts

Chien-CHIh Wang, MD
Contact
candycandywang@gmail.com
886-958738258

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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