NCT04040283

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.

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
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

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

January 1, 2014

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

July 31, 2019

Status Verified

July 1, 2019

Enrollment Period

5 years

First QC Date

July 29, 2019

Last Update Submit

July 29, 2019

Conditions

Keywords

Growth factorsMeniscal injury

Outcome Measures

Primary Outcomes (2)

  • Knee injury and Osteoarthritis Outcome Score scale

    6months post procedure

  • Visual Analog Scale

    6months post procedure

Secondary Outcomes (2)

  • International Knee Documentation Committee - Subjective Knee Evaluation Form

    6months post procedure

  • Satisfaction Level

    6months post procedure

Interventions

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.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ivan Medina-Porqueres

Málaga, Spain

RECRUITING

MeSH Terms

Interventions

Therapeutics

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 29, 2019

First Posted

July 31, 2019

Study Start

January 1, 2014

Primary Completion

January 1, 2019

Study Completion

November 1, 2019

Last Updated

July 31, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations