Augmentation of Meniscal Repair With Marrow Stimulation Techniques (Microfractures)

Not Applicable

Completed

• Conditions: Meniscus Lesion
• Interventions: Procedure: with microfractures; Procedure: without microfractures

• Registration Number: NCT02323490
• Lead Sponsor: Centre of Postgraduate Medical Education

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.

Study Timeline

• Study Start: 2013-08-19
• Study First Submitted: 2014-12-17
• Study First Submitted QC: 2014-12-22
• Study First Posted: 2014-12-23
• Primary Completion: 2016-02
• Study Completion: 2018-04
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-10
• Last Update Posted: 2018-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
with microfractures	with microfractures	Standardized meniscal repair with bone marrow stimulation techniques (microfractures)
without microfractures	without microfractures	Standardized meniscal repair without augmentation

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Prof. A. Gruca Teaching Hospital, The Medical Centre of Postgraduate Education; 🇵🇱 Otwock, Woj. Mazowieckie, Poland