NCT03734900

Brief Summary

This study will focus on grade I to III knee osteoarthritis by randomized controlled trials which comparing the effectiveness between placebo, autologous platelet rich plasma and autologous platelet lysate injections.

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
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2018

Longer than P75 for phase_4

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

Study Start

First participant enrolled

May 15, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 8, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2022

Completed
Last Updated

September 20, 2021

Status Verified

July 1, 2021

Enrollment Period

4 years

First QC Date

October 25, 2018

Last Update Submit

September 16, 2021

Conditions

Osteoarthritis (OA) of the Knee

Outcome Measures

Primary Outcomes (1)

  • Pain score of the patient

    Using Visual Analog Score (from 0 to 10, 0 indicate no pain and 10 indicate maximal pain) to evaluate pain of surgical wound of the patient

    up to 24 weeks after surgery

Secondary Outcomes (4)

  • Knee functional score

    up to 24 weeks after surgery

  • X-ray

    up to 24 weeks after surgery

  • Ultrasonic image

    up to 24 weeks after surgery

  • adverse events

    up to 24 weeks after surgery

Study Arms (3)

Saline injection

PLACEBO COMPARATOR

Sodium Chloride injection into the study knee joint every 4 weeks for a total of 3 injections

Other: Saline injection

PRP injection

EXPERIMENTAL

PRP injection into the study knee joint every 4 weeks for a total of 3 injections

Biological: PRP injection

PL injection

EXPERIMENTAL

PL injection into the study knee joint every 4 weeks for a total of 3 injections Platelet lysate is the product of nature activation from autologous platelet.

Biological: PL injection

Interventions

Saline injectionOTHER

5ml Placebo infusion of 0.9% Sodium Chloride

Saline injection
PRP injectionBIOLOGICAL

Device: "Aeon" Acti-PRP 5ml autologous platelet rich plasma injection

PRP injection
PL injectionBIOLOGICAL

Device: "Aeon" Acti-PRP 5ml autologous platelet lysate injection

PL injection

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 80 years old
  • Study Subjects must be willing to sign Informed Consent to participate in the study
  • In the past month, at least seven consecutive days in the squat, standing, walking or going up and down the stairs, the most serious degree of visual analogy of the knee pain (Visual Analogue Scale) is greater than or equal to 40 (the most pain is 100, not painful is 0)
  • Morning joint stiffness is less than 30 minutes
  • X-ray：Grade 1-3 radiographic OA as defined by the K-L classification

You may not qualify if:

  • Knee instability
  • The knee joint is obviously deformed (\> 5 degree valgus or varus deviation on X-ray)
  • Clinical diagnosed as Pes tendinitis, Chondromalacia
  • Taking NSAIDs or steroids (including oral and injection) within one week
  • Using anticoagulant drugs for a long time
  • Platelet count is less than 150,000 / UL, or coagulation disorders, prothrombin time (PT value) is less than 11 seconds or greater than 16 seconds
  • Leukemia, sepsis, platelet dysfunction or other blood related diseases
  • tumors, infections or the trauma before the same site
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Wu Chueh-Hung, MD, CIPS

    National Taiwan University Hospital

    STUDY DIRECTOR

Central Study Contacts

WU Chueh-Hung, MD, CIPS

CONTACT

0223123456nojred@gmail.com

Wang Tyng-Guey, MD

CONTACT

0223123456tgw@ntu.edu.tw

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2018

First Posted

November 8, 2018

Study Start

May 15, 2018

Primary Completion

May 14, 2022

Study Completion

May 14, 2022

Last Updated

September 20, 2021

Record last verified: 2021-07

Locations

TW(1)