NCT03167333

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 25, 2017

Completed
2.8 years until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

Same day

First QC Date

May 18, 2017

Last Update Submit

February 9, 2020

Conditions

Synovitis of KneeOsteoarthritis, Knee

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (3)

  • 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)

Study Arms (2)

PRP group

EXPERIMENTAL

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

Drug: platelet rich plasma

HA group

ACTIVE COMPARATOR

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

Drug: Hyaluronic acid

Interventions

platelet rich plasmaDRUG

The amount of PPR was about 4-5 cc

PRP group
Hyaluronic acidDRUG

HA was 2.5cc

HA group

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed with OA knee according to ACR guideline
  • stiffness less than 30min
  • cracking sound during activity
  • more than 30min pain for last 2 months
  • non-bed ridden patients
  • no structure abnormality
  • synovitis was proved by US

You may not qualify if:

  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei veteran general hospital yuli branch

Hualien City, 886, Taiwan

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Central Study Contacts

Chien-CHIh Wang, MD

CONTACT

886-958738258candycandywang@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2017

First Posted

May 25, 2017

Study Start

March 1, 2020

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

February 11, 2020

Record last verified: 2020-02

Locations

TW(1)