Clinical trial NCT02203045: 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
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Total Knee Arthroplasty
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Colorado Joint Replacement
name: CommonSpirit Health
First posted: 2014-07-29
Enrollment: 28
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from baseline in Quadriceps Muscle Force
timeFrame: Pre-operative, 3 weeks and 3 months post-operative
Secondary outcomes:
measure: Change from Baseline in Balance testing
timeFrame: Pre-operatively, 3 weeks and 3 months post-operative
measure: Change from Baseline in Isometric Hamstring Strength
timeFrame: Pre-operatively, 3 weeks and 3 months post-operative
measure: Change from Baseline from Voluntary Quadriceps Activation
timeFrame: Pre-operative, 3 weeks and 3 months post-operative
measure: Change from Baseline in Range of Motion
timeFrame: Pre-operatively, 3 weeks and 3 months post-operatively
Other outcomes:
measure: Radiographic Examination
timeFrame: 1 to 2 months post surgery
measure: Deep Vein Thrombosis Formation
timeFrame: 48- 72 hours post operative
measure: Postoperative blood loss
timeFrame: 48 hours post surgery
measure: Lower extremity edema
timeFrame: 48- 72 hours postoperative
measure: Verbal analog scale pain assessment
timeFrame: Pre-Operative, 3 weeks and 3 months post-operative
Locations:
city: Aurora
country: United States
facility: Univeristy of Colorado
state: Colorado
city: Denver
country: United States
facility: Colorado Joint Replacement
state: Colorado
Study officials:
affiliation: Colorado Joint Replacement
name: Douglas Dennis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Jennifer Stevens-Lapsley, MPT and PhD
role: STUDY_DIRECTOR
affiliation: Colorado Joint Replacement
name: Ray Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: