The Influence of Wedge Insoles After Partial Meniscectomy

March 21, 2018 updated by: Dammerer Dietmar, MD, Medical University Innsbruck

Effect of Orthotic Devices in the Recovery After Partial Meniscectomy

Research on the implications of orthotic devices and the recovery after knee arthroscopy are widely known. But only a handful of specific issues have been studied to date. However, the effect of orthotic devices on the recovery after partial meniscectomy are largely unknown. To our best knowledge, there are no studies that deal with the treatment of partial medial or lateral meniscectomy with wedge insoles, valgus or varus knee braces. The purpose of this study is to find out if using wedge inserts or knee orthoses improve the outcomes after partial meniscectomy.

We therefore verify the following hypothesis: In patients with partial meniscectomy can be by the postoperative use of exculpatory wedge deposits or relieving knee brace achieve a significantly better clinical outcome than without specific treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

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 Locations

  • Austria
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Department of Orthopedic; Medical University of Innsbruck

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • full leg x-ray to measure the leg axis
  • undersigned Informed Consent Form

Exclusion Criteria:

  • at the same time conducted or within one year subsequent corrective osteotomies of the leg axis
  • medial meniscectomy combination and valgus
  • combination of lateral meniscectomy and varus
  • psychiatric or neurological comorbidities that produce a poor compliance
  • forth degree cartilage lesions or evident osteoarthritis
  • concomitant lesion of the collateral ligaments
  • insufficient knowledge of the study language

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: No specific treatment
No specific treatment after partial meniscectomy
OTHER: Wedge Insole with 5mm wedge angel
Participants wear a wedge insole after partial meniscectomy
Device: Wedge Insole 5mm
OTHER: Knee Brace
Participants wear a knee brace after partial meniscectomy
Device: Knee Brace

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Knee-specific questionnaires which combine an activity and a quality of life score.
Time Frame: Two years
Two years

Collaborators and Investigators

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

Sponsor

Medical University Innsbruck

Investigators

  • Principal Investigator: Michael Liebensteiner, Priv. Doz. Mag. Dr. PhD, Department of Orthopedic, Medical University of Innsbruck

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

March 1, 2014

Primary Completion (ACTUAL)

December 1, 2017

Study Completion (ACTUAL)

January 1, 2018

Study Registration Dates

First Submitted

July 12, 2014

First Submitted That Met QC Criteria

July 14, 2014

First Posted (ESTIMATE)

July 15, 2014

Study Record Updates

Last Update Posted (ACTUAL)

March 23, 2018

Last Update Submitted That Met QC Criteria

March 21, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 602010072014
  • 602011072014 (OTHER: Austria:)

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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