Platelet-rich Plasma for Menical Tear | NCT04040283

Studies
Platelet-rich Plasma for Menical Tear

NCT04040283

Sponsor

University of Malaga

Status

Unknown status

Last Update Posted

Jul 31, 2019Actual

Enrollment

15Estimated

Phase

Not provided

Conditions

Platelet-Rich Plasma
Meniscus Lesion

Interventions

Platelet-rich plasma (PRP) therapy

Countries

Spain

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 2019

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

Jan 2014Actual

Primary Completion Date

Jan 2019Actual

Completion Date

Nov 2019Estimated

First Submitted Date

Jul 29, 2019

First Submission Date that Met QC Criteria

Jul 29, 2019

First Posted Date

Jul 31, 2019Actual

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

Jul 29, 2019

Last Update Posted Date

Jul 31, 2019Actual

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

Meniscal injuries are a common pathology among athletes, and have an impact on the daily or sporting practice of patients. Surgical approach implies sometimes heavy consequences. Platelet-rich-plasma (PRP) has been shown to be effective in accelerating wound healing and tissue regeneration in orthopedic and oral surgery. This clinical trial aims to investigate the safety and efficacy of intraarticular and periferal PRP injection in patients with stable meniscal injury. The pre- and post-interventional clinical outcomes will be compared.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Platelet-rich plasma (PRP) therapy	Procedure	Platelet rich plasma (PRP) describes a technique in which platelets are isolated from a sample of a person's own blood using simple cell-separating systems such as centrifugation in order to obtain highly concentrated samples of platelets that can be re-injected into an injury site to promote healing.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Knee injury and Osteoarthritis Outcome Score scale		6months post procedure
Visual Analog Scale		6months post procedure

Secondary Outcomes

Measure	Description	Time Frame
International Knee Documentation Committee - Subjective Knee Evaluation Form		6months post procedure
Satisfaction Level		6months post procedure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Skeletally mature patients 18-70 years of age
With diagnosis of meniscus injury
Single tear of the medial and/or lateral meniscus
With no indication of meniscus repair surgery

Exclusion Criteria:

Prior history of multiple ligaments injury, associated significant ligament instability: Grade III MCL, Grade III PCL, or ACL deficient knee
Prior history of knee surgery
Discoid meniscus
Osteoarthritic changes (Kellgren Lawrence scale >2)
Inflammatory diseases (i.e. rheumatoid arthritis)
Underlying bleeding disorder or coagulopathy
Concominant chondral defects (> 2 ICRS)
Cancer patients
Pregnancy
Patients who will not cooperate with six-month followup

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Skeletally mature patients aged between 18 and 70 years with imaging and clinical diagnosis of meniscus injury and no indication of meniscus repair surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ivan Medina-Porqueres	Recruiting	Málaga			Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013812	Therapeutics

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided