Outcomes Following Tourniquet and Non-Tourniquet Assisted Total Knee Arthroplasty

May 13, 2015 updated by: University of Colorado, Denver
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Colorado
      • Aurora, Colorado, United States, 80045
        • Univeristy of Colorado
      • Denver, Colorado, United States, 80210
        • Colorado Joint Replacement

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tourniquet
All lower extremities will be exsanguinated by elevation for 2 minutes. For lower extremities in the tourniquet group (TQT), a pneumatic tourniquet will be inflated according to standard practice (>200 mmHg). For the NOTQT group, the tourniquet will only be inflated during component cementation. In both groups, tourniquet will be deflated after bone cement has set. In both groups, electrocautery will be used as needed throughout the procedure.
Experimental: Non- tourniquet
All lower extremities will be exsanguinated by elevation for 2 minutes. For lower extremities in the tourniquet group (TQT), a pneumatic tourniquet will be inflated according to standard practice (>200 mmHg). For the NOTQT group, the tourniquet will only be inflated during component cementation. In both groups, tourniquet will be deflated after bone cement has set. In both groups, electrocautery will be used as needed throughout the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Pre-operative, 3 weeks and 3 months post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Balance testing
Time Frame: Pre-operatively, 3 weeks and 3 months post-operative
Patients will be asked to perform a test of unilateral balance ability. Patients will place both hands on their hips before assuming a single limb stance. Patients will attempt to hold this position for a maximum time of 60 seconds, although timing will stop if patients ever place both feet on the ground, if the non-stance leg braces against the stance leg to control balance, or if hands are removed from the hips to regain balance.
Pre-operatively, 3 weeks and 3 months post-operative
Change from Baseline in Isometric Hamstring Strength
Time Frame: Pre-operatively, 3 weeks and 3 months post-operative
Pre-operatively, 3 weeks and 3 months post-operative
Change from Baseline from Voluntary Quadriceps Activation
Time Frame: Pre-operative, 3 weeks and 3 months post-operative
Pre-operative, 3 weeks and 3 months post-operative
Change from Baseline in Range of Motion
Time Frame: Pre-operatively, 3 weeks and 3 months post-operatively
Knee flexion and extension range of motion (ROM) will be quantified using a standard long-arm goniometer with the patient lying in supine. Knee flexion ROM will be defined as the angle of maximal active bending of the knee. Knee extension ROM will be the angle of maximal straightening while the patient's heel is propped on a 10cm wooden block. If hyperextension is achieved, then the degrees of extension beyond zero will be recorded as a negative value.
Pre-operatively, 3 weeks and 3 months post-operatively

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic Examination
Time Frame: 1 to 2 months post surgery
Radiographic examination will be used to provide preliminary data on rates of fracture and tibiofemoral joint malalignment specific to the use of tourniquet during surgery.
1 to 2 months post surgery
Deep Vein Thrombosis Formation
Time Frame: 48- 72 hours post operative
48- 72 hours post operative
Postoperative blood loss
Time Frame: 48 hours post surgery
48 hours post surgery
Lower extremity edema
Time Frame: 48- 72 hours postoperative
48- 72 hours postoperative
Verbal analog scale pain assessment
Time Frame: Pre-Operative, 3 weeks and 3 months post-operative
Pre-Operative, 3 weeks and 3 months post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Douglas Dennis, MD, Colorado Joint Replacement
  • Study Director: Jennifer Stevens-Lapsley, MPT and PhD, University of Colorado, Denver
  • Principal Investigator: Ray Kim, MD, Colorado Joint Replacement

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

July 24, 2014

First Submitted That Met QC Criteria

July 25, 2014

First Posted (Estimate)

July 29, 2014

Study Record Updates

Last Update Posted (Estimate)

May 15, 2015

Last Update Submitted That Met QC Criteria

May 13, 2015

Last Verified

October 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 12-0648

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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