Clinical trial NCT03167333: The Role of Synovitis in Osteoarthritis
Official title: Does Synovitis Affect Treatment Efficacy in Intra-articular Injection Therapy to Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Synovitis of Knee
Osteoarthritis, Knee
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2017-05-25
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: visual analog scale(VAS)
timeFrame: before injection at baseline
measure: visual analog scale(VAS)
timeFrame: 4 weeks(first evaluation)
measure: visual analog scale(VAS)
timeFrame: 12 weeks(secondary evaluation)
measure: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index)
timeFrame: before injection at baseline
measure: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index)
timeFrame: 4 weeks(first evaluation)
measure: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index)
timeFrame: 12 weeks(secondary evaluation)
Secondary outcomes:
measure: Imaging evaluation based on color Doppler ultrasound(CDUS) and the depth of synovial fluid accumulation ,and the width of synovial hypertrophy was performed simultaneously.
timeFrame: before injection at baseline
measure: Imaging evaluation based on color Doppler ultrasound(CDUS) and the depth of synovial fluid accumulation ,and the width of synovial hypertrophy was performed
timeFrame: 4 weeks(first evaluation)
measure: Imaging evaluation based on color Doppler ultrasound(CDUS) and the depth of synovial fluid accumulation ,and the width of synovial hypertrophy was performed
timeFrame: 12 weeks(secondary evaluation)
Other outcomes:
Locations:
city: Hualien City
country: Taiwan
facility: Taipei veteran general hospital yuli branch
Study officials:
References: