NCT02323490

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 19, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 23, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

June 12, 2018

Status Verified

June 1, 2018

Enrollment Period

2.5 years

First QC Date

December 17, 2014

Last Update Submit

June 10, 2018

Conditions

Meniscus Lesion

Keywords

meniscus repairbone marrow stimulation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

    6 weeks, 12 weeks, 6mts, 1yr post op, 2yrs post op, 3 yrs post op

  • 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)

    6 weeks, 12 weeks, 6mts, 1yr post op, 2yrs post op, 3 yrs post op

Study Arms (2)

with microfractures

EXPERIMENTAL

Standardized meniscal repair with bone marrow stimulation techniques (microfractures)

Procedure: with microfractures

without microfractures

PLACEBO COMPARATOR

Standardized meniscal repair without augmentation

Procedure: without microfractures

Interventions

with microfracturesPROCEDURE

following meniscal repair, microfractures will be created on the intercondylar and outer part of femoral condyle (outside of joint surface), lateral or medial, respectively

with microfractures
without microfracturesPROCEDURE

standard procedure meniscal repair without augmentation.

without microfractures

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. A. Gruca Teaching Hospital, The Medical Centre of Postgraduate Education

Otwock, Woj. Mazowieckie, 05-400, Poland

Location

Related Publications (1)

  • 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.

    PMID: 30902532DERIVED

Study Officials

  • Rafał Kamiński, M.D. Ph.D.

    SPSK Prof A. Gruca Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. Ph.D.

Study Record Dates

First Submitted

December 17, 2014

First Posted

December 23, 2014

Study Start

August 19, 2013

Primary Completion

February 1, 2016

Study Completion

April 1, 2018

Last Updated

June 12, 2018

Record last verified: 2018-06

Locations

PL(1)