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Clinical Trials/NCT02203045
NCT02203045
Completed
Not Applicable

Outcomes Following Tourniquet and Non-Tourniquet Assisted Total Knee Arthroplasty

University of Colorado, Denver2 sites in 1 country28 target enrollmentOctober 2012
ConditionsOsteoarthritis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis
Sponsor
University of Colorado, Denver
Enrollment
28
Locations
2
Primary Endpoint
Change from baseline in Quadriceps Muscle Force
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

The overall goal of this study is to determine the effects of intraoperative tourniquet use during total knee arthroplasty (TKA), compared to TKA without the use of a tourniquet (NOTQT), for strength and functional recovery following simultaneous bilateral TKA. During the procedure, each patient will receive tourniquet-assisted TKA (TQT) on one lower extremity while the contralateral lower extremity undergoes TKA without the use of a tourniquet (NOTQT), except for briefly during component cementation. Tourniquets are commonly used in TKA to improve visualization of the surgical field and limit blood loss. However, studies suggest that tourniquet use may be associated with higher rates of medical complications and poor functional outcomes, including increased swelling, decreased muscle strength and altered neuromuscular activity. We will measure strength, voluntary muscle activation, and other functional outcomes for each lower extremity at 4 time points (preop; inpatient (24-72 hrs after surgery); 3 weeks; and 3 months following TKA). We hypothesize that lower extremities in the NOTQT group will demonstrate improved strength and performance when compared to lower extremities in the TQT group.

Registry
clinicaltrials.gov
Start Date
October 2012
End Date
August 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • undergoing primary, simultaneous bilateral knee arthroplasty for osteoarthritis

Exclusion Criteria

  • no neurological, vascular or cardiac problems that limit function or any unstable orthopaedic conditions that limit functional performance

Outcomes

Primary Outcomes

Change from baseline in Quadriceps Muscle Force

Time Frame: Pre-operative, 3 weeks and 3 months post-operative

NOTQT will result in greater quadriceps muscle strength (primary outcome) after TKA, compared to TQT group. Benefits will be apparent at 48-72 hrs and 3 weeks (primary endpoint), and persist though 3 months following TKA

Secondary Outcomes

  • Change from Baseline in Isometric Hamstring Strength(Pre-operatively, 3 weeks and 3 months post-operative)
  • Change from Baseline from Voluntary Quadriceps Activation(Pre-operative, 3 weeks and 3 months post-operative)
  • Change from Baseline in Balance testing(Pre-operatively, 3 weeks and 3 months post-operative)
  • Change from Baseline in Range of Motion(Pre-operatively, 3 weeks and 3 months post-operatively)

Study Sites (2)

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