The Role of Synovitis in Osteoarthritis

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

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.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis, Knee; Synovitis of Knee
• Intervention / Treatment: Drug: platelet rich plasma; Drug: Hyaluronic acid

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chien-CHIh Wang, MD; Phone Number: 886-958738258; Email: candycandywang@gmail.com

Study Locations

• Taiwan
  • Hualien City, Taiwan, 886
    • Recruiting
    • Taipei veteran general hospital yuli branch
    • Contact: Chien-Chih Wang; Phone Number: 886 958738258; Email: candycandywang@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 43 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRP group; the patients received PRP(platelet-rich-plasma) injection twice at 2-week intervals	Drug: platelet rich plasma; The amount of PPR was about 4-5 cc
Active Comparator: HA group; the patients received HA(hyaluronic acid) injection twice at 2-week intervals	Drug: Hyaluronic acid; HA was 2.5cc

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
visual analog scale(VAS)	before injection at baseline
visual analog scale(VAS)	4 weeks(first evaluation)
visual analog scale(VAS)	12 weeks(secondary evaluation)
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index)	before injection at baseline
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index)	4 weeks(first evaluation)
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index)	12 weeks(secondary evaluation)

Secondary Outcome Measures

Outcome Measure	Time Frame
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	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	12 weeks(secondary evaluation)

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: May 18, 2017
• First Submitted That Met QC Criteria: May 24, 2017
• First Posted (Actual): May 25, 2017

Study Record Updates

• Last Update Posted (Actual): February 11, 2020
• Last Update Submitted That Met QC Criteria: February 9, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Synovitis; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: 2017-03-009B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No