Platelet-rich Plasma for Menical Tear

Meniscus Lesion Clinical Trial

Official title:

Platelet-rich Plasma for Menical Tear

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04040283
• Other study ID #: UMalaga21
• Status: Recruiting
• Start date: January 2014
• Est. completion date: November 2019

Study information

• Verified date: July 2019
• Source: University of Malaga
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: November 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Meniscus Lesion
• Platelet-Rich Plasma

Intervention

Procedure:
• Platelet-rich plasma (PRP) therapy
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.

Locations

Country	Name	City	State
Spain	Ivan Medina-Porqueres	Malaga

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaga

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee injury and Osteoarthritis Outcome Score scale		6months post procedure
Primary	Visual Analog Scale		6months post procedure
Secondary	International Knee Documentation Committee - Subjective Knee Evaluation Form		6months post procedure
Secondary	Satisfaction Level		6months post procedure