NCT03066583

Effectiveness of Trephination With Platelet Rich Plasma or Placebo in a Primary Meniscal Tear Treatment

Prospective, Randomised, Double Blinded Trial Comparing Effectiveness of Platelet Rich Plasma or Placebo in a Primary Meniscal Tear Treatment

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Centre of Postgraduate Medical Education · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study will compare meniscal healing augmented or without augmentation with platelet rich plasma in primary meniscal tear treatment (prolotherapy). The assessments will include validated, disease specific, patient oriented outcome measures. Results of this study will help ascertain whether platelet rich plasma may improve meniscal healing rates.

Detailed description

The role of meniscal in the knee integrity is pivotal and lack or partial role of the meniscus increases rate of joint degeneration. Partial meniscal removal is the most popular procedure and meniscal repair remain in minority of arthroscopic surgeries. As criteria of inclusion to meniscal repair are very rough, still success rates of meniscal repair remain in the 60-80% range for isolated repairs. This rate is greater when performed with ACL reconstruction. The investigators believe that augmentation with platelet rich plasma as prolotherapy ill induce healing without the need for arthroscopy.

Conditions

• Meniscus Lesion

Interventions

Type	Name	Description
BIOLOGICAL	trephination with placebo	trephination under US guidance and placebo injection
BIOLOGICAL	trephination with platelet rich plasma	trephination under US guidance and platelet rich plasma injection

Timeline

• Start date: 2016-01-01
• Primary completion: 2019-01-01
• Completion: 2020-06-01
• First posted: 2017-02-28
• Last updated: 2020-06-02

Locations

1 site across 1 country: Poland