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

Phase 2

Completed

• Conditions: Meniscus Lesion
• Interventions: Biological: trephination with placebo; Biological: trephination with platelet rich plasma

• Registration Number: NCT03066583
• Lead Sponsor: Centre of Postgraduate Medical Education

Brief 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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-10-21
• Study First Submitted QC: 2017-02-27
• Study First Posted: 2017-02-28
• Primary Completion: 2019-01
• Status Verified: 2020-06
• Study Completion: 2020-06
• Last Update Submitted: 2020-06-01
• Last Update Posted: 2020-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Complete horizontal 10 mm in length
• Tear located in the vascular/avascular portion of the meniscus (chronic horizontal tear on MR)
• Single tear of the medial and/or lateral meniscus
• Skeletally mature patients 18-70 years of age

Exclusion Criteria

• discoid meniscus
• arthritic changes (Kellgren Lawrence scale >2) or axial leg deformity (valgus > 6 deg)
• inflammatory diseases (i.e. rheumatoid arthritis)
• concominant chondral defects (> 2 ICRS)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
trephination with placebo	trephination with placebo	meniscal repair with trephination and placebo
trephination with platelet rich plasma	trephination with platelet rich plasma	meniscal repair with trephination and platelet rich plasma

Primary Outcome Measures

Name	Time	Method
Assessment of meniscal healing by MR scanning	by 1 year	The primary outcome measures will be assessment of meniscal healing integrity by MR scanning

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale	12 weeks, 6months, 1year post procedure	Pain Visual Analog Scale.
Knee injury and Osteoarthritis Outcome Score scale	12 weeks, 6months, 1year post procedure	Knee injury and Osteoarthritis Outcome Score
International Knee Documentation Committee - Subjective Knee Evaluation Form	12 weeks, 6months, 1year post procedure	International Knee Documentation Committee - Subjective Knee Evaluation Form

Trial Locations

Locations (1)

Department of Orthopaedics and Traumatology, Postgraduate Center for Medical Education, Professor A. Gruca Teaching Hospital; 🇵🇱 Otwock, Mazowieckie, Poland