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Completed

NCT Number: NCT02323490

Augmentation of Meniscal Repair With Marrow Stimulation Techniques (Microfractures)

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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Key information

Conditions

Meniscus Lesion

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prof. A. Gruca Teaching Hospital, The Medical Centre of Postgraduate Education

Otwock, Woj. Mazowieckie, 05-400, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

with microfractures

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

Procedure

standard procedure meniscal repair without augmentation.

Primary outcomes

  1. Second look arthroscopy (assessment of meniscal healing integrity during second look)

    Time frame: 8-18 weeks

    The primary outcome measures will be assessment of meniscal healing integrity during second look arthroscopy 3-5 months post repair.

Secondary outcomes

  1. Visual Analog Scale

    Time frame: 6 weeks, 12 weeks, 6mts, 1yr post op, 2yrs post op, 3 yrs post op

    Pain Visual Analog Scale.

  2. Knee injury and Osteoarthritis Outcome Score scale

    Time frame: 6 weeks, 12 weeks, 6mts, 1yr post op, 2yrs post op, 3 yrs post op

    Knee injury and Osteoarthritis Outcome Score

  3. International Knee Documentation Committee - Subjective Knee Evaluation Form

    Time frame: 6 weeks, 12 weeks, 6mts, 1yr post op, 2yrs post op, 3 yrs post op

    International Knee Documentation Committee - Subjective Knee Evaluation Form

  4. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: 6 weeks, 12 weeks, 6mts, 1yr post op, 2yrs post op, 3 yrs post op

    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Sponsors and collaborators

Lead sponsor

Centre of Postgraduate Medical Education

Other

Registry information

Official study title

Augmentation of Meniscal Repair With Bone Marrow Stimulation Techniques (Microfractures): a Double Blind, Prospective, Randomized Clinical Trial of Efficacy and Safety.

Acronym: men_micro

Important dates

Study start
2013
Primary completion
2016
Study completion
2018
First posted
Dec 23, 2014
Registry last updated
Jun 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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