Balance After Knee Arthroplasty

NCT ID: NCT04681404

Last Updated: 2023-03-30

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-11

Study Completion Date

2023-12-31

Brief Summary

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Evaluation of patients before and after knee arthroplasty regarding balance, function and quality of life. Comparison of total and unicompartmental knee arthroplasty. Comparison of the primary outcome parameter and selected secondary outcome parameters to healthy controls.

Detailed Description

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Conditions

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Postural Balance Knee Arthroplasty Quality of Life

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Total Knee Arthroplasty (TKA)

Patients intended to undergo surgery for total knee arthroplasty

Group Type ACTIVE_COMPARATOR

Knee Arthroplasty

Intervention Type PROCEDURE

Comparison of TKA, UKA and healthy controls in relation to balance, function and QOL

Unicompartmental Knee Arthroplasty (UKA)

Patients intended to undergo surgery for unicompartmental knee arthroplasty

Group Type ACTIVE_COMPARATOR

Knee Arthroplasty

Intervention Type PROCEDURE

Comparison of TKA, UKA and healthy controls in relation to balance, function and QOL

Healthy Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Knee Arthroplasty

Comparison of TKA, UKA and healthy controls in relation to balance, function and QOL

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Primary gonarthrosis
* planned TKA or UKA
* adequate cognitive and lingual competence
* informed consent

Exclusion Criteria

* TKA or UKA revision
* Surgery after trauma
* Rheumatic disease
* Neurologic disease
* previous arthroplasty of the lower extremity (\<9 months)
* cardiovascular disease
* restricted weight bearing of the lower extremity after surgery
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kepler University Hospital

OTHER

Sponsor Role collaborator

Johannes Kepler University of Linz

OTHER

Sponsor Role lead

Responsible Party

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Christian Mittermaier

Christian Mittermaier, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian Mittermaier, Dr

Role: PRINCIPAL_INVESTIGATOR

Kepler University Hospital

Locations

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Kepler University Hospital

Linz, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Christian Mittermaier, Dr

Role: CONTACT

+43 5 7680 83 ext. 73779

Facility Contacts

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Christian Mittermaier, M.D.

Role: primary

Other Identifiers

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PMR_Knee TKA 001

Identifier Type: -

Identifier Source: org_study_id

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