Clinical trial NCT02323490: Augmentation of Meniscal Repair With Marrow Stimulation Techniques (Microfractures)
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
Overall status: COMPLETED
Phase: NA
Conditions: Meniscus Lesion
Keywords: meniscus repair
bone marrow stimulation
Lead sponsor: Centre of Postgraduate Medical Education
Sponsor class: OTHER
First posted: 2014-12-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Second look arthroscopy (assessment of meniscal healing integrity during second look)
timeFrame: 8-18 weeks
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: 6 weeks, 12 weeks, 6mts, 1yr post op, 2yrs post op, 3 yrs post op
measure: Knee injury and Osteoarthritis Outcome Score scale
timeFrame: 6 weeks, 12 weeks, 6mts, 1yr post op, 2yrs post op, 3 yrs post op
measure: International Knee Documentation Committee - Subjective Knee Evaluation Form
timeFrame: 6 weeks, 12 weeks, 6mts, 1yr post op, 2yrs post op, 3 yrs post op
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 6 weeks, 12 weeks, 6mts, 1yr post op, 2yrs post op, 3 yrs post op
Other outcomes:
Locations:
city: Otwock
country: Poland
facility: Prof. A. Gruca Teaching Hospital, The Medical Centre of Postgraduate Education
state: Woj. Mazowieckie
Study officials:
affiliation: SPSK Prof A. Gruca Hospital
name: Rafał Kamiński, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.