Alterations in Muscle After Total Knee Arthroplasty

NCT ID: NCT02281877

Last Updated: 2021-06-09

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2020-03-09

Brief Summary

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The overall goals of this work are: 1) to elucidate alterations in gene expression and downstream protein synthesis 2 weeks after Total Knee Arthroplasty (TKA) to better explain quadriceps muscle atrophy after TKA and 2) understand the mechanisms responsible for improved maintenance of muscle strength with Neuromuscular Electrical Stimulation (NMES) utilization. Furthermore, this investigation seeks to expand previous findings regarding attenuation of strength and functional performance deficits with NMES application to better understand how altered gene expression influences muscle function.

Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Neuromuscular Electrical Stimulation

Neuromuscular Electrical Stimulation (NMES) 48 hours after TKA, 5x/week, 2x/day, for 45 minutes/session.

Standard Rehabilitation Protocol

Group Type EXPERIMENTAL

Neuromuscular electrical stimulation (NMES)

Intervention Type PROCEDURE

5x/week, 2x/day, for 45 minutes/session

Standard Rehabilitation Protocol

Intervention Type BEHAVIORAL

Standard physical therapy after TKA

Control

Standard Rehabilitation Protocol

Group Type ACTIVE_COMPARATOR

Standard Rehabilitation Protocol

Intervention Type BEHAVIORAL

Standard physical therapy after TKA

Interventions

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Neuromuscular electrical stimulation (NMES)

5x/week, 2x/day, for 45 minutes/session

Intervention Type PROCEDURE

Standard Rehabilitation Protocol

Standard physical therapy after TKA

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 50 to 75 years of age
* Scheduled for unilateral TKA at University of Colorado Hospital
* Diagnosed with osteoarthritis
* Cognitive status that allows patients to consistently comprehend and repeat back directions regarding the details of the study

Exclusion Criteria

* Neurological, vascular or cardiac problems that significantly limit function
* BMI \> 35
* Testosterone supplementation
* Pregnancy
* Anticoagulant therapy
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Victor Cheuy, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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Univeristy of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

University of Colorado School of Medicine

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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14-0905

Identifier Type: -

Identifier Source: org_study_id

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