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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2020-06-30

Brief Summary

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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.

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Detailed Description

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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

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Meniscus Lesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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trephination with placebo

meniscal repair with trephination and placebo

Group Type PLACEBO_COMPARATOR

trephination with placebo

Intervention Type BIOLOGICAL

trephination under US guidance and placebo injection

trephination with platelet rich plasma

meniscal repair with trephination and platelet rich plasma

Group Type EXPERIMENTAL

trephination with platelet rich plasma

Intervention Type BIOLOGICAL

trephination under US guidance and platelet rich plasma injection

Interventions

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trephination with placebo

trephination under US guidance and placebo injection

Intervention Type BIOLOGICAL

trephination with platelet rich plasma

trephination under US guidance and platelet rich plasma injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes