The Influence of Wedge Insoles After Partial Meniscectomy

NCT ID: NCT02190188

Last Updated: 2018-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2018-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Partial Meniscectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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No specific treatment

No specific treatment after partial meniscectomy

Group Type NO_INTERVENTION

No interventions assigned to this group

Wedge Insole with 5mm wedge angel

Participants wear a wedge insole after partial meniscectomy

Group Type OTHER

Wedge Insole 5mm

Intervention Type DEVICE

Knee Brace

Participants wear a knee brace after partial meniscectomy

Group Type OTHER

Knee Brace

Intervention Type DEVICE

Interventions

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Wedge Insole 5mm

Intervention Type DEVICE

Knee Brace

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University Innsbruck

OTHER

Sponsor Role lead

Responsible Party

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Dammerer Dietmar, MD

MD, MSc, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Liebensteiner, Priv. Doz. Mag. Dr. PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopedic, Medical University of Innsbruck

Locations

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Department of Orthopedic; Medical University of Innsbruck

Innsbruck, Tyrol, Austria

Site Status

Countries

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Austria

Other Identifiers

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602011072014

Identifier Type: OTHER

Identifier Source: secondary_id

602010072014

Identifier Type: -

Identifier Source: org_study_id

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