The Role of Synovitis in Osteoarthritis

Taipei Veterans General Hospital

Status: Unknown

Conditions: Synovitis of Knee; Osteoarthritis, Knee

Treatments: Drug: Hyaluronic acid; Drug: platelet rich plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT03167333

2017-03-009B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

PRP group

Experimental group

Description:

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

Treatment:

Drug: platelet rich plasma

HA group

Active Comparator group

Description:

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

Treatment:

Drug: Hyaluronic acid