The Role of Synovitis in Osteoarthritis

Not Applicable

• Conditions: Synovitis of Knee; Osteoarthritis, Knee
• Interventions: Drug: Hyaluronic acid; Drug: platelet rich plasma

• Registration Number: NCT03167333
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

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.

Study Timeline

• Study First Submitted: 2017-05-18
• Study First Submitted QC: 2017-05-24
• Study First Posted: 2017-05-25
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-09
• Last Update Posted: 2020-02-11
• Study Start: 2020-03-01
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HA group	Hyaluronic acid	the patients received HA(hyaluronic acid) injection twice at 2-week intervals
PRP group	platelet rich plasma	the patients received PRP(platelet-rich-plasma) injection twice at 2-week intervals

Primary Outcome Measures

Name	Time	Method
visual analog scale(VAS)	12 weeks(secondary evaluation)
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index)	12 weeks(secondary evaluation)

Secondary Outcome Measures

Name	Time	Method
Imaging evaluation based on color Doppler ultrasound(CDUS) and the depth of synovial fluid accumulation ,and the width of synovial hypertrophy was performed simultaneously.	before injection at baseline
Imaging evaluation based on color Doppler ultrasound(CDUS) and the depth of synovial fluid accumulation ,and the width of synovial hypertrophy was performed	12 weeks(secondary evaluation)

Trial Locations

Locations (1)

Taipei veteran general hospital yuli branch; 🇨🇳 Hualien City, Taiwan