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Gait Analysis Meniscal Repair

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ClinicalTrials.gov Identifier: NCT02474004
Recruitment Status : Unknown
Verified July 2016 by Michael Liebensteiner, Medical University Innsbruck.
Recruitment status was:  Recruiting
First Posted : June 17, 2015
Last Update Posted : July 19, 2016
Sponsor:
Information provided by (Responsible Party):
Michael Liebensteiner, Medical University Innsbruck

Brief Summary:

In the past it was shown, that medial partial meniscectomy (MPM) leads to an increase of the knee adduction moment (KAM) during walking. Other researches found out that an increase of the KAM is an important factor contributing to degeneration joint disease of the knee (osteoarthritis). Today, medial menicus repair (MMR) is favoured by many knee surgeons, because preserving as much of the meniscus as possible is assumed to delay degenerative joint disease.

The investigators hypothesize significant differences in knee adduction moments between patients treated with partial medial meniscectomy vs. patients treated with medial meniscus repair (hypothesis 1; major hypothesis). Additionally, it is hypothesized that: the mentioned groups differ with respect to other kinetic and kinematic key parameters of gait (hypothesis 2) and that the knee adduction moment correlates with the clinical outcome as determined by a typical knee score (hypothesis 3).


Condition or disease Intervention/treatment Phase
Lesion of the Medial Meniscus Procedure: medial meniscal surgery Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 3D-gait Analysis in Patients With Medial Meniscus Repair vs. Partial Meniscectomy
Study Start Date : February 2012
Estimated Primary Completion Date : February 2017

Arm Intervention/treatment
Experimental: medial meniscus repair
patients receiving medial meniscus repair
Procedure: medial meniscal surgery
one group/arm has meniscal repair as part of clinical routine one group/arm has meniscal partial resection as part of clinical routine both groups have gait analysis & knee scores 6 mo after the procedures

Active Comparator: medial partial meniscectomy
patients having medial partial meniscectomy
Procedure: medial meniscal surgery
one group/arm has meniscal repair as part of clinical routine one group/arm has meniscal partial resection as part of clinical routine both groups have gait analysis & knee scores 6 mo after the procedures




Primary Outcome Measures :
  1. knee adduction moment [Nm/kg] [ Time Frame: once after 6 months ]
    a parameter of gait analysis


Secondary Outcome Measures :
  1. set of kinetic, kinematic and temporospatial gait parameters [ Time Frame: once after 6 months ]
    other gait parameters


Other Outcome Measures:
  1. KOOS [ Time Frame: 6 months post ]
    knee specific patient-reported outcome measurement



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Ages Eligible for Study:   10 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: patients with traumatic medial meniscus lesions scheduled for meniscal repair or resection

Exclusion Criteria:

  • previous or current diseases of the back and the other joints of the lower limbs
  • any form of inflammatory arthritis
  • diabetes
  • neurological disorders
  • other conditions that may affect gait

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02474004


Contacts
Contact: Michael C Liebensteiner, MD, PhD +43 512 504 80547 michael.liebensteiner@i-med.ac.at

Locations
Austria
Innsbruck Medical University, Dept. Orthop. Surgery Recruiting
Innsbruck, Tyrol, Austria, 6020
Principal Investigator: Michael C Liebensteiner, MD, PhD         
Sportsclinic Austria Recruiting
Innsbruck, Tyrol, Austria, 6020
Principal Investigator: Christian Fink, Prof. MD         
Sponsors and Collaborators
Michael Liebensteiner

Responsible Party: Michael Liebensteiner, Physician, Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT02474004     History of Changes
Other Study ID Numbers: GAIT-Men1
First Posted: June 17, 2015    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: July 2016