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Outcomes Following Tourniquet and Non-Tourniquet Assisted Total Knee Arthroplasty

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Total Knee Arthroplasty
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Total Knee Arthroplasty

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Univeristy of Colorado
  • Colorado Joint Replacement

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Tourniquet

Non- tourniquet

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline in Quadriceps Muscle Force
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 Outcome Measures

Change from Baseline in Balance testing
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.
Change from Baseline in Isometric Hamstring Strength
Change from Baseline from Voluntary Quadriceps Activation
Change from Baseline in Range of Motion
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.

Full Information

First Posted
July 24, 2014
Last Updated
May 13, 2015
Sponsor
University of Colorado, Denver
Collaborators
Colorado Joint Replacement, Centura Health
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1. Study Identification

Unique Protocol Identification Number
NCT02203045
Brief Title
Outcomes Following Tourniquet and Non-Tourniquet Assisted Total Knee Arthroplasty
Official Title
Outcomes Following Tourniquet and Non-Tourniquet Assisted Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Colorado Joint Replacement, Centura Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Total Knee Arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tourniquet
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Non- tourniquet
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Total Knee Arthroplasty
Primary Outcome Measure Information:
Title
Change from baseline in Quadriceps Muscle Force
Description
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
Time Frame
Pre-operative, 3 weeks and 3 months post-operative
Secondary Outcome Measure Information:
Title
Change from Baseline in Balance testing
Description
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.
Time Frame
Pre-operatively, 3 weeks and 3 months post-operative
Title
Change from Baseline in Isometric Hamstring Strength
Time Frame
Pre-operatively, 3 weeks and 3 months post-operative
Title
Change from Baseline from Voluntary Quadriceps Activation
Time Frame
Pre-operative, 3 weeks and 3 months post-operative
Title
Change from Baseline in Range of Motion
Description
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.
Time Frame
Pre-operatively, 3 weeks and 3 months post-operatively
Other Pre-specified Outcome Measures:
Title
Radiographic Examination
Description
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.
Time Frame
1 to 2 months post surgery
Title
Deep Vein Thrombosis Formation
Time Frame
48- 72 hours post operative
Title
Postoperative blood loss
Time Frame
48 hours post surgery
Title
Lower extremity edema
Time Frame
48- 72 hours postoperative
Title
Verbal analog scale pain assessment
Time Frame
Pre-Operative, 3 weeks and 3 months post-operative

10. Eligibility

Sex
All
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Dennis, MD
Organizational Affiliation
Colorado Joint Replacement
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jennifer Stevens-Lapsley, MPT and PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ray Kim, MD
Organizational Affiliation
Colorado Joint Replacement
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univeristy of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Colorado Joint Replacement
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States

12. IPD Sharing Statement

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Outcomes Following Tourniquet and Non-Tourniquet Assisted Total Knee Arthroplasty

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