Gait Analysis Meniscal Repair

July 16, 2016 updated by: Michael Liebensteiner

3D-gait Analysis in Patients With Medial Meniscus Repair vs. Partial Meniscectomy

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
knee adduction moment [Nm/kg]
Time Frame: once after 6 months
a parameter of gait analysis
once after 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
set of kinetic, kinematic and temporospatial gait parameters
Time Frame: once after 6 months
other gait parameters
once after 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
KOOS
Time Frame: 6 months post
knee specific patient-reported outcome measurement
6 months post

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michael Liebensteiner

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Anticipated)

February 1, 2017

Study Registration Dates

First Submitted

June 4, 2015

First Submitted That Met QC Criteria

June 12, 2015

First Posted (Estimate)

June 17, 2015

Study Record Updates

Last Update Posted (Estimate)

July 19, 2016

Last Update Submitted That Met QC Criteria

July 16, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • GAIT-Men1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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