Augmentation of Meniscal Repair With Marrow Stimulation Techniques (Microfractures) (men_micro)

Centre of Postgraduate Medical Education

Status: Completed

Conditions: Meniscus Lesion

Treatments: Procedure: with microfractures; Procedure: without microfractures

Study type: Interventional

Funder types: Other

Identifiers

NCT02323490

men_micro

Details and patient eligibility

About

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.

Full 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. We believe that augmentation with bone marrow stimulation techniques will induce more complete and possibly faster healing.

Enrollment: 40 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

with microfractures

Experimental group

Description:

Standardized meniscal repair with bone marrow stimulation techniques (microfractures)

Treatment:

Procedure: with microfractures

without microfractures

Placebo Comparator group

Description:

Standardized meniscal repair without augmentation

Treatment:

Procedure: without microfractures