The Role of Synovitis in Osteoarthritis

Osteoarthritis, Knee Clinical Trial

Official title:

Does Synovitis Affect Treatment Efficacy in Intra-articular Injection Therapy to Osteoarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03167333
• Other study ID #: 2017-03-009B
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: March 1, 2020

Study information

• Verified date: February 2020
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Chien-CHIh Wang, MD
• Phone: 886-958738258
• Email: candycandywang[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Synovitis
• Synovitis of Knee

Intervention

Drug:
• platelet rich plasma
The amount of PPR was about 4-5 cc
• Hyaluronic acid
HA was 2.5cc

Locations

Country	Name	City	State
Taiwan	Taipei veteran general hospital yuli branch	Hualien City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analog scale(VAS)		before injection at baseline
Primary	visual analog scale(VAS)		4 weeks(first evaluation)
Primary	visual analog scale(VAS)		12 weeks(secondary evaluation)
Primary	The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index)		before injection at baseline
Primary	The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index)		4 weeks(first evaluation)
Primary	The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index)		12 weeks(secondary evaluation)
Secondary	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
Secondary	Imaging evaluation based on color Doppler ultrasound(CDUS) and the depth of synovial fluid accumulation ,and the width of synovial hypertrophy was performed		4 weeks(first evaluation)
Secondary	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)