Comparison of Effectiveness Between PL and PRP on Knee Os... | NCT03734900

Studies
Comparison of Effectiveness Between PL and PRP on Knee Osteoarthritis: a Prospective,Randomized,Placebo-controlled Trial

NCT03734900

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Sep 20, 2021Actual

Enrollment

150Estimated

Phase

Phase 4

Conditions

Osteoarthritis (OA) of the Knee

Interventions

Saline injection
PRP injection
PL injection

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2018Actual

Primary Completion Date

May 14, 2022Estimated

Completion Date

May 14, 2022Estimated

First Submitted Date

Oct 25, 2018

First Submission Date that Met QC Criteria

Nov 6, 2018

First Posted Date

Nov 8, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2021

Last Update Posted Date

Sep 20, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The current methods for treating knee osteoarthritis include delaying the disease progression and joint replacement surgery. The usual treatment methods are mostly temporary, such as taking drug and hyaluronic acid injection. Therefore, finding the safe and effective methods will greatly reduce medical resource, medical expenses and surgery cost, etc., and restore the patient's quality of life. Platelet lysate is the product of complete activation from autologous platelet. It contains rich growth factors and cytokines such as PDGF, TGF-β, VEGF, EGF and IGF, etc. It can support cell growth and doesn't have any white blood cells in it. It is superior to the platelet rich plasma because of reducing the overall inflammatory response and pain of the patient during treatment.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Saline injection	Other	5ml Placebo infusion of 0.9% Sodium Chloride	Saline injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Knee functional score	Using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	up to 24 weeks after surgery
X-ray	Knee X-ray image

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

50 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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
WU Chueh-Hung, MD, CIPS	Contact	0223123456	66473	nojred@gmail.com
Wang Tyng-Guey, MD	Contact	0223123456	67588	tgw@ntu.edu.tw

Overall Officials

Name	Affiliation	Role
Wu Chueh-Hung, MD, CIPS	National Taiwan University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei		100	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided