Can PRP Reduce Pro-Inflammatory Biomarkers Following ACL... | NCT03389685

Studies
Can PRP Reduce Pro-Inflammatory Biomarkers Following ACL Injury

NCT03389685

Sponsor

NYU Langone Health

Status

Withdrawn

Last Update Posted

Apr 15, 2024Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

ACL - Anterior Cruciate Ligament Rupture
ACL Injury

Interventions

Platelet Rich Plasma
Saline Placebo

Countries

United States

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

Apr 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

COVID-19, Lack of Funding

Expanded Access Info

Start Date

Sep 9, 2018Actual

Primary Completion Date

Feb 2024Estimated

Completion Date

Feb 2024Estimated

First Submitted Date

Dec 26, 2017

First Submission Date that Met QC Criteria

Dec 26, 2017

First Posted Date

Jan 3, 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

Apr 12, 2024

Last Update Posted Date

Apr 15, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this single-center, double-blinded randomized control trial with prospective data collection is to assess the ability of platelet rich plasma (PRP) treatment to reduce the level of pro-inflammatory synovial fluid biomarkers following an acute anterior cruciate ligament (ACL) tear. The study will collect and analyze synovial fluid of patients presenting with an acute anterior cruciate ligament (ACL) tear with a second synovial fluid sampling at the time of surgery. It will compare synovial fluid biomarker levels between those receiving an intra-articular Platelet Rich Plasma (PRP) injection versus an intra-articular saline injection serving as a control. Post-operative clinical outcomes will also be assessed, including post-operative pain levels, incidence of post-operative knee stiffness and patient reported outcome scores.

Detailed Description

Not provided

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Platelet Rich Plasma	Experimental	Platelet Rich Plasma will be prepared using Genesis CS EmCyte PurePRP II system.	Biological: Platelet Rich Plasma
Saline Placebo	Placebo Comparator	Unmarked syringe with 5 ml of saline	Other: Saline Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Platelet Rich Plasma	Biological	Pure PRPII®, leukocyte-poor, platelet rich plasma	Platelet Rich Plasma

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
synovial fluid biomarker levels	The synovial fluid samples obtained at the two time points will be analyzed for the presence of 20 biomarkers using a multiplex bead assay (Milliplex®, Millipore, Billerica MA)	2 Days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients have suffered an acute ACL tear (initial presentation within 7 days of injury) with or without an associated meniscus injury
Patient must undergo ACL reconstruction surgery

Exclusion Criteria:

Mentally impaired (e.g, Alzheimer's subjects, dementia, etc.)
Younger than 18 years of age
Patients who have a multiligamentous injury
Patients with underlying inflammatory arthropathies
Previous ACL injury and/or reconstruction

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric Strauss, MD	NYU Langone Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New York University School of Medicine		New York	New York	10016	United States

Condition Browse Module

MeSH Terms

ID	Term
D000070598	Anterior Cruciate Ligament Injuries

Ancestor Terms

ID	Term
D007718	Knee Injuries
D007869	Leg Injuries
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided