NCT00224913

Brief Summary

Total knee arthroplasty (TKA) is performed more than 300,000 times a year in the United States, most often for osteoarthritis (OA). While pain is predictably reduced, function does not typically ever reach that of age-matched, uninjured subjects. Quadriceps weakness has been implicated in the development and progression of knee OA and is a significant problem after TKA. Voluntary exercise has been ineffective at restoring quadriceps strength after TKA. The aims of this study are: 1) to assess the effectiveness of high-level neuromuscular electrical stimulation as an adjunct to ongoing intensive, early rehabilitation in restoring quadriceps strength and improving the functional outcome after primary TKA, and 2) to identify the physiological and morphological bases for improvements in quadriceps strength and functional outcome.

Trial Health

55
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Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2005

Completed
Last Updated

October 12, 2005

Status Verified

October 1, 2005

First QC Date

September 21, 2005

Last Update Submit

October 11, 2005

Conditions

Total Knee ArthroplastyOsteoarthritis

Keywords

osteoarthritisquadricepsinhibitionfunctional outcomeelectrical stimulation

Outcome Measures

Primary Outcomes (3)

  • Quadriceps Strength

  • Quadriceps Activation

  • Functional Tests

Secondary Outcomes (1)

  • Self reports of function

Interventions

Neuromuscular electrical stimulationPROCEDURE
Voluntary exercisePROCEDURE

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • TKA for unilateral tricompartmental knee OA

You may not qualify if:

  • Insulin dependent diabetes
  • neurological conditions
  • other lower extremity orthopedic problems that affect function
  • BMI\>40

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Delaware

Newark, Delaware, 19716, United States

RECRUITING

Related Publications (9)

  • Mizner RL, Petterson SC, Stevens JE, Axe MJ, Snyder-Mackler L. Preoperative quadriceps strength predicts functional ability one year after total knee arthroplasty. J Rheumatol. 2005 Aug;32(8):1533-9.

    PMID: 16078331BACKGROUND

  • Mizner RL, Petterson SC, Stevens JE, Vandenborne K, Snyder-Mackler L. Early quadriceps strength loss after total knee arthroplasty. The contributions of muscle atrophy and failure of voluntary muscle activation. J Bone Joint Surg Am. 2005 May;87(5):1047-53. doi: 10.2106/JBJS.D.01992.

    PMID: 15866968BACKGROUND

  • Mizner RL, Snyder-Mackler L. Altered loading during walking and sit-to-stand is affected by quadriceps weakness after total knee arthroplasty. J Orthop Res. 2005 Sep;23(5):1083-90. doi: 10.1016/j.orthres.2005.01.021. Epub 2005 Mar 28.

    PMID: 16140191RESULT

  • Mizner RL, Petterson SC, Snyder-Mackler L. Quadriceps strength and the time course of functional recovery after total knee arthroplasty. J Orthop Sports Phys Ther. 2005 Jul;35(7):424-36. doi: 10.2519/jospt.2005.35.7.424.

    PMID: 16108583RESULT

  • Stevens JE, Mizner RL, Snyder-Mackler L. Neuromuscular electrical stimulation for quadriceps muscle strengthening after bilateral total knee arthroplasty: a case series. J Orthop Sports Phys Ther. 2004 Jan;34(1):21-9. doi: 10.2519/jospt.2004.34.1.21.

    PMID: 14964588RESULT

  • Stevens JE, Mizner RL, Snyder-Mackler L. Quadriceps strength and volitional activation before and after total knee arthroplasty for osteoarthritis. J Orthop Res. 2003 Sep;21(5):775-9. doi: 10.1016/S0736-0266(03)00052-4.

    PMID: 12919862RESULT

  • Mizner RL, Stevens JE, Snyder-Mackler L. Voluntary activation and decreased force production of the quadriceps femoris muscle after total knee arthroplasty. Phys Ther. 2003 Apr;83(4):359-65.

    PMID: 12665406RESULT

  • Laufer Y, Snyder-Mackler L. Response of male and female subjects after total knee arthroplasty to repeated neuromuscular electrical stimulation of the quadriceps femoris muscle. Am J Phys Med Rehabil. 2010 Jun;89(6):464-72. doi: 10.1097/PHM.0b013e3181dd8c0e.

    PMID: 20489392DERIVED

  • Petterson SC, Mizner RL, Stevens JE, Raisis L, Bodenstab A, Newcomb W, Snyder-Mackler L. Improved function from progressive strengthening interventions after total knee arthroplasty: a randomized clinical trial with an imbedded prospective cohort. Arthritis Rheum. 2009 Feb 15;61(2):174-83. doi: 10.1002/art.24167.

    PMID: 19177542DERIVED

MeSH Terms

Conditions

OsteoarthritisInhibition, Psychological

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Study Officials

  • Lynn Snyder-Mackler, PT, ScD

    University of Delaware

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lynn Snyder-Mackler, PT, ScD

CONTACT

302-831-3613smack@udel.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

September 21, 2005

First Posted

September 23, 2005

Study Start

March 1, 2002

Last Updated

October 12, 2005

Record last verified: 2005-10

Locations

US(1)