- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02203045
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
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
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-
Colorado
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Aurora, Colorado, United States, 80045
- Univeristy of Colorado
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Denver, Colorado, United States, 80210
- Colorado Joint Replacement
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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
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Pre-operative, 3 weeks and 3 months post-operative
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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.
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Pre-operatively, 3 weeks and 3 months post-operative
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Change from Baseline in Isometric Hamstring Strength
Time Frame: Pre-operatively, 3 weeks and 3 months post-operative
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Pre-operatively, 3 weeks and 3 months post-operative
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Change from Baseline from Voluntary Quadriceps Activation
Time Frame: Pre-operative, 3 weeks and 3 months post-operative
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Pre-operative, 3 weeks and 3 months post-operative
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Change from Baseline in Range of Motion
Time Frame: Pre-operatively, 3 weeks and 3 months post-operatively
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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.
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Pre-operatively, 3 weeks and 3 months post-operatively
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiographic Examination
Time Frame: 1 to 2 months post surgery
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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.
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1 to 2 months post surgery
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Deep Vein Thrombosis Formation
Time Frame: 48- 72 hours post operative
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48- 72 hours post operative
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Postoperative blood loss
Time Frame: 48 hours post surgery
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48 hours post surgery
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Lower extremity edema
Time Frame: 48- 72 hours postoperative
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48- 72 hours postoperative
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Verbal analog scale pain assessment
Time Frame: Pre-Operative, 3 weeks and 3 months post-operative
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Pre-Operative, 3 weeks and 3 months post-operative
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
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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