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

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

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.

Study Overview

• Status: Completed
• Conditions: Meniscus Lesion
• Intervention / Treatment: Procedure: with microfractures; Procedure: without microfractures

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Woj. Mazowieckie
    • Otwock, Woj. Mazowieckie, Poland, 05-400
      • Prof. A. Gruca Teaching Hospital, The Medical Centre of Postgraduate Education

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: with microfractures; Standardized meniscal repair with bone marrow stimulation techniques (microfractures)	Procedure: 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
Placebo Comparator: without microfractures; Standardized meniscal repair without augmentation	Procedure: without microfractures; standard procedure meniscal repair without augmentation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Second look arthroscopy (assessment of meniscal healing integrity during second look)	The primary outcome measures will be assessment of meniscal healing integrity during second look arthroscopy 3-5 months post repair.	8-18 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale	Pain Visual Analog Scale.	6 weeks, 12 weeks, 6mts, 1yr post op, 2yrs post op, 3 yrs post op
Knee injury and Osteoarthritis Outcome Score scale	Knee injury and Osteoarthritis Outcome Score	6 weeks, 12 weeks, 6mts, 1yr post op, 2yrs post op, 3 yrs post op
International Knee Documentation Committee - Subjective Knee Evaluation Form	International Knee Documentation Committee - Subjective Knee Evaluation Form	6 weeks, 12 weeks, 6mts, 1yr post op, 2yrs post op, 3 yrs post op
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	6 weeks, 12 weeks, 6mts, 1yr post op, 2yrs post op, 3 yrs post op

Collaborators and Investigators

• Sponsor: Centre of Postgraduate Medical Education
• Investigators: Principal Investigator: Rafał Kamiński, M.D. Ph.D., SPSK Prof A. Gruca Hospital

Publications and helpful links

General Publications

• Kaminski R, Kulinski K, Kozar-Kaminska K, Wasko MK, Langner M, Pomianowski S. Repair Augmentation of Unstable, Complete Vertical Meniscal Tears With Bone Marrow Venting Procedure: A Prospective, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study. Arthroscopy. 2019 May;35(5):1500-1508.e1. doi: 10.1016/j.arthro.2018.11.056. Epub 2019 Mar 20.

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2013
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: December 17, 2014
• First Submitted That Met QC Criteria: December 22, 2014
• First Posted (Estimate): December 23, 2014

Study Record Updates

• Last Update Posted (Actual): June 12, 2018
• Last Update Submitted That Met QC Criteria: June 10, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: bone marrow stimulation; meniscus repair
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Fractures, Stress
• Other Study ID Numbers: men_micro

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED