NCT02281877

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2014

Completed
28 days until next milestone

First Posted

Study publicly available on registry

November 4, 2014

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2020

Completed
Last Updated

June 9, 2021

Status Verified

June 1, 2021

Enrollment Period

5.4 years

First QC Date

October 7, 2014

Last Update Submit

June 7, 2021

Conditions

Knee Osteoarthritis

Keywords

Total Knee Arthroplasty (TKA)Gene Expression

Outcome Measures

Primary Outcomes (1)

  • Catabolic gene expression

    Standard procedures including total RNA isolation, cDNA synthesis, cRNA labeling, microarray hybridization and image acquisition will be performed. Protein content (translation of MAFbx, MuRF1, myostatin) will be analyzed. Total RNA (500 ng) will be reverse transcribed with the iScript cDNA synthesis kit (Bio-Rad, Hercules, CA), and quantitative PCR will be performed using primer sets for genes of interest, reference genes and iQ SYBR Supermix (Bio-Rad) following manufacturer's protocols.

    Change in gene expression from immediately pre surgery to 2 weeks after surgery

Secondary Outcomes (7)

  • Changes in quadriceps strength

    3 days Pre operative and 2 weeks post operative

  • Changes in quadriceps size

    3 days Pre operative and 2 weeks post operative

  • Changes in quadriceps activation

    3 days Pre operative and 2 weeks post operative

  • Functional Performance Measures (4 meter walk test, timed up and go, stair climbing test)

    3 days Pre operative and 2 weeks post operative

  • Anabolic Gene Expression

    Immediately pre surgery to 2 weeks after surgery

  • +2 more secondary outcomes

Study Arms (2)

Neuromuscular Electrical Stimulation

EXPERIMENTAL

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

Procedure: Neuromuscular electrical stimulation (NMES)Behavioral: Standard Rehabilitation Protocol

Control

ACTIVE COMPARATOR

Standard Rehabilitation Protocol

Behavioral: Standard Rehabilitation Protocol

Interventions

Neuromuscular electrical stimulation (NMES)PROCEDURE

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

Neuromuscular Electrical Stimulation
Standard Rehabilitation ProtocolBEHAVIORAL

Standard physical therapy after TKA

ControlNeuromuscular Electrical Stimulation

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Neurological, vascular or cardiac problems that significantly limit function
  • BMI \> 35
  • Testosterone supplementation
  • Pregnancy
  • Anticoagulant therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Univeristy of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Victor Cheuy, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2014

First Posted

November 4, 2014

Study Start

October 1, 2014

Primary Completion

March 9, 2020

Study Completion

March 9, 2020

Last Updated

June 9, 2021

Record last verified: 2021-06

Locations

US(2)