Augmentation of Meniscal Repair With Marrow Stimulation Techniques (Microfractures)

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

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-19

Study Completion Date

2018-04-30

Brief Summary

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This study will compare meniscal healing augmented or without augmentation with bone marrow stimulation techniques The assessments will include validated, disease specific, patient oriented outcome measures, second look arthroscopy during second step ACL reconstruction. Results of this study will help ascertain whether microfractures 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. We believe that augmentation with bone marrow stimulation techniques will induce more complete and possibly faster healing.

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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with microfractures

Standardized meniscal repair with bone marrow stimulation techniques (microfractures)

Group Type EXPERIMENTAL

with microfractures

Intervention Type PROCEDURE

following meniscal repair, microfractures will be created on the intercondylar and outer part of femoral condyle (outside of joint surface), lateral or medial, respectively

without microfractures

Standardized meniscal repair without augmentation

Group Type PLACEBO_COMPARATOR

without microfractures

Intervention Type PROCEDURE

standard procedure meniscal repair without augmentation.

Interventions

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with microfractures

following meniscal repair, microfractures will be created on the intercondylar and outer part of femoral condyle (outside of joint surface), lateral or medial, respectively

Intervention Type PROCEDURE

without microfractures

standard procedure meniscal repair without augmentation.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Complete vertical longitudinal tear \> 10 mm in length
* Tear located in the vascular portion of the meniscus, only in red-white zone
* Unstable peripheral tear
* Single tear of the medial and/or lateral meniscus
* Meniscal injury 1 -18 month prior surgery
* Planned second step arthroscopy (ACL reconstruction)
* Skeletally mature patients 18-55 years of age

Exclusion Criteria

* discoid meniscus
* arthritic changes (Kellgren Lawrence scale \>2)
* non repairable meniscus
* degenerative or presence of crystals in meniscus
* concomitant procedure (acl reconstruction, microfracturing, trephination)
* inflammatory diseases (i.e. rheumatoid arthritis)

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No