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Outcomes Following Tourniquet and Non-Tourniquet Assisted Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT02203045
Recruitment Status : Completed
First Posted : July 29, 2014
Last Update Posted : May 15, 2015
Sponsor:
Collaborators:
Colorado Joint Replacement
Centura Health
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Other: Total Knee Arthroplasty Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Outcomes Following Tourniquet and Non-Tourniquet Assisted Total Knee Arthroplasty
Study Start Date : October 2012
Actual Primary Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

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.
Other: Total Knee Arthroplasty
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.
Other: Total Knee Arthroplasty



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. Change from Baseline in Isometric Hamstring Strength [ Time Frame: Pre-operatively, 3 weeks and 3 months post-operative ]
  3. Change from Baseline from Voluntary Quadriceps Activation [ Time Frame: Pre-operative, 3 weeks and 3 months post-operative ]
  4. 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.


Other Outcome Measures:
  1. 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.

  2. Deep Vein Thrombosis Formation [ Time Frame: 48- 72 hours post operative ]
  3. Postoperative blood loss [ Time Frame: 48 hours post surgery ]
  4. Lower extremity edema [ Time Frame: 48- 72 hours postoperative ]
  5. Verbal analog scale pain assessment [ Time Frame: Pre-Operative, 3 weeks and 3 months post-operative ]


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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02203045


Locations
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United States, Colorado
Univeristy of Colorado
Aurora, Colorado, United States, 80045
Colorado Joint Replacement
Denver, Colorado, United States, 80210
Sponsors and Collaborators
University of Colorado, Denver
Colorado Joint Replacement
Centura Health
Investigators
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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
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02203045    
Other Study ID Numbers: 12-0648
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: May 15, 2015
Last Verified: October 2014
Keywords provided by University of Colorado, Denver:
Total Knee Arthroplasty
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases