The Role of Synovitis in Osteoarthritis

Taipei Veterans General Hospital, Taiwan100 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Synovitis of Knee Osteoarthritis, Knee

Interventions

platelet rich plasmaDRUG

The amount of PPR was about 4-5 cc

Hyaluronic acidDRUG

HA was 2.5cc

Eligibility

Sex: ALLMin age: 45 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Taipei veteran general hospital yuli branch

Hualien City, Taiwan

RECRUITING

Outcomes

Primary Outcomes

visual analog scale(VAS)

Time frame: before injection at baseline

visual analog scale(VAS)

Time frame: 4 weeks(first evaluation)

visual analog scale(VAS)

Time frame: 12 weeks(secondary evaluation)

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

Time frame: before injection at baseline

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

Time frame: 4 weeks(first evaluation)

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

Time frame: 12 weeks(secondary evaluation)

Secondary Outcomes

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

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)

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)

Central Contacts

Chien-CHIh Wang, MD

CONTACT

886-958738258 candycandywang@gmail.com

Data from ClinicalTrials.gov

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