Outcomes Following Tourniquet and Non-Tourniquet Assisted Total Knee Arthroplasty

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

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.

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• 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

More Information

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT02203045
• Other Study ID Numbers: 12-0648
• First Posted: July 29, 2014
• Last Update Posted: May 15, 2015
• Last Verified: October 2014

Keywords provided by University of Colorado, Denver:

Total Knee Arthroplasty

Additional relevant MeSH terms:

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases