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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02474004
Other study ID # GAIT-Men1
Secondary ID
Status Recruiting
Phase N/A
First received June 4, 2015
Last updated July 16, 2016
Start date February 2012

Study information

Verified date July 2016
Source Medical University Innsbruck
Contact Michael C Liebensteiner, MD, PhD
Phone +43 512 504 80547
Email michael.liebensteiner@i-med.ac.at
Is FDA regulated No
Health authority Federal Ministry for Labour, Health, and Social Affairs: Austria
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date
Est. primary completion date February 2017
Accepts healthy volunteers No
Gender Both
Age group 10 Years to 60 Years
Eligibility 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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Austria Innsbruck Medical University, Dept. Orthop. Surgery Innsbruck Tyrol
Austria Sportsclinic Austria Innsbruck Tyrol

Sponsors (1)

Lead Sponsor Collaborator
Michael Liebensteiner

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Other KOOS knee specific patient-reported outcome measurement 6 months post No
Primary knee adduction moment [Nm/kg] a parameter of gait analysis once after 6 months No
Secondary set of kinetic, kinematic and temporospatial gait parameters other gait parameters once after 6 months No