Outcomes Following Tourniquet and Non-Tourniquet Assisted Total Knee Arthroplasty

NCT ID: NCT02203045

Last Updated: 2015-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Total Knee Arthroplasty

Intervention Type: OTHER

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.

Group Type: EXPERIMENTAL

Total Knee Arthroplasty

Intervention Type: OTHER

Interventions

Total Knee Arthroplasty

Intervention Type: OTHER

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

• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Colorado Joint Replacement

OTHER

Sponsor Role: collaborator

CommonSpirit Health

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Douglas Dennis, MD

Role: PRINCIPAL_INVESTIGATOR

Colorado Joint Replacement

Jennifer Stevens-Lapsley, MPT and PhD

Role: STUDY_DIRECTOR

University of Colorado, Denver

Ray Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Colorado Joint Replacement

Locations

Univeristy of Colorado

Aurora, Colorado, United States

Colorado Joint Replacement

Denver, Colorado, United States

Countries

United States

Other Identifiers

12-0648

Identifier Type: -

Identifier Source: org_study_id