Platelet-rich Plasma for Menical Tear
1 other identifier
observational
15
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
July 29, 2019
CompletedFirst Posted
Study publicly available on registry
July 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedJuly 31, 2019
July 1, 2019
5 years
July 29, 2019
July 29, 2019
Conditions
Keywords
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
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
MeSH Terms
Interventions
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