Platelet-rich Plasma for Menical Tear

July 29, 2019 updated by: Ivan Medina-Porqueres, University of Malaga
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Malaga, Spain
        • Recruiting
        • Ivan Medina-Porqueres
        • Contact:
          • Ivan Medina-Porqueres, Professor
          • Phone Number: 0034951952858
          • Email: imp@uma.es

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaga

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

January 1, 2019

Study Completion (Anticipated)

November 1, 2019

Study Registration Dates

First Submitted

July 29, 2019

First Submitted That Met QC Criteria

July 29, 2019

First Posted (Actual)

July 31, 2019

Study Record Updates

Last Update Posted (Actual)

July 31, 2019

Last Update Submitted That Met QC Criteria

July 29, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UMalaga21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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