The Role of Synovitis in Osteoarthritis

NCT ID: NCT03167333

Last Updated: 2020-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2020-03-01

Brief Summary

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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

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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.

Conditions

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Synovitis of Knee Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PRP group

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

Group Type EXPERIMENTAL

platelet rich plasma

Intervention Type DRUG

The amount of PPR was about 4-5 cc

HA group

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

Group Type ACTIVE_COMPARATOR

Hyaluronic acid

Intervention Type DRUG

HA was 2.5cc

Interventions

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platelet rich plasma

The amount of PPR was about 4-5 cc

Intervention Type DRUG

Hyaluronic acid

HA was 2.5cc

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Taipei veteran general hospital yuli branch

Hualien City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chien-CHIh Wang, MD

Role: CONTACT

886-958738258

Facility Contacts

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Chien-Chih Wang

Role: primary

886 958738258

Other Identifiers

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2017-03-009B

Identifier Type: -

Identifier Source: org_study_id

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