Augmentation of Meniscal Repair With Marrow Stimulation Techniques (Microfractures) (men_micro)
Primary Purpose
Meniscus Lesion
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
with microfractures
without microfractures
Sponsored by
About this trial
This is an interventional treatment trial for Meniscus Lesion focused on measuring meniscus repair, bone marrow stimulation
Eligibility Criteria
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)
Sites / Locations
- Prof. A. Gruca Teaching Hospital, The Medical Centre of Postgraduate Education
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
with microfractures
without microfractures
Arm Description
Standardized meniscal repair with bone marrow stimulation techniques (microfractures)
Standardized meniscal repair without augmentation
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Visual Analog Scale
Pain Visual Analog Scale.
Knee injury and Osteoarthritis Outcome Score scale
Knee injury and Osteoarthritis Outcome Score
International Knee Documentation Committee - Subjective Knee Evaluation Form
International Knee Documentation Committee - Subjective Knee Evaluation Form
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Full Information
NCT ID
NCT02323490
First Posted
December 17, 2014
Last Updated
June 10, 2018
Sponsor
Centre of Postgraduate Medical Education
1. Study Identification
Unique Protocol Identification Number
NCT02323490
Brief Title
Augmentation of Meniscal Repair With Marrow Stimulation Techniques (Microfractures)
Acronym
men_micro
Official Title
Augmentation of Meniscal Repair With Bone Marrow Stimulation Techniques (Microfractures): a Double Blind, Prospective, Randomized Clinical Trial of Efficacy and Safety.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
August 19, 2013 (Actual)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre of Postgraduate Medical Education
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meniscus Lesion
Keywords
meniscus repair, bone marrow stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
with microfractures
Arm Type
Experimental
Arm Description
Standardized meniscal repair with bone marrow stimulation techniques (microfractures)
Arm Title
without microfractures
Arm Type
Placebo Comparator
Arm Description
Standardized meniscal repair without augmentation
Intervention Type
Procedure
Intervention Name(s)
with microfractures
Intervention Description
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
Intervention Name(s)
without microfractures
Intervention Description
standard procedure meniscal repair without augmentation.
Primary Outcome Measure Information:
Title
Second look arthroscopy (assessment of meniscal healing integrity during second look)
Description
The primary outcome measures will be assessment of meniscal healing integrity during second look arthroscopy 3-5 months post repair.
Time Frame
8-18 weeks
Secondary Outcome Measure Information:
Title
Visual Analog Scale
Description
Pain Visual Analog Scale.
Time Frame
6 weeks, 12 weeks, 6mts, 1yr post op, 2yrs post op, 3 yrs post op
Title
Knee injury and Osteoarthritis Outcome Score scale
Description
Knee injury and Osteoarthritis Outcome Score
Time Frame
6 weeks, 12 weeks, 6mts, 1yr post op, 2yrs post op, 3 yrs post op
Title
International Knee Documentation Committee - Subjective Knee Evaluation Form
Description
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
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafał Kamiński, M.D. Ph.D.
Organizational Affiliation
SPSK Prof A. Gruca Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prof. A. Gruca Teaching Hospital, The Medical Centre of Postgraduate Education
City
Otwock
State/Province
Woj. Mazowieckie
ZIP/Postal Code
05-400
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30902532
Citation
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.
Results Reference
derived
Learn more about this trial
Augmentation of Meniscal Repair With Marrow Stimulation Techniques (Microfractures)
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