Augmentation of Meniscal Repair With Marrow Stimulation Techniques (Microfractures)

Meniscus Lesion Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02323490
• Other study ID #: men_micro
• Status: Completed
• Phase: N/A
• Start date: August 19, 2013
• Est. completion date: April 2018

Study information

• Verified date: June 2018
• Source: Centre of Postgraduate Medical Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2018
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Fractures, Stress
• Meniscus Lesion

Intervention

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
• without microfractures
standard procedure meniscal repair without augmentation.

Locations

Country	Name	City	State
Poland	Prof. A. Gruca Teaching Hospital, The Medical Centre of Postgraduate Education	Otwock	Woj. Mazowieckie

Sponsors (1)

Lead Sponsor	Collaborator
Centre of Postgraduate Medical Education

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Visual Analog Scale	Pain Visual Analog Scale.	6 weeks, 12 weeks, 6mts, 1yr post op, 2yrs post op, 3 yrs post op
Secondary	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
Secondary	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
Secondary	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