Outcomes Following Tourniquet and Non-Tourniquet Assisted Total Knee Arthroplasty

Osteoarthritis Clinical Trial

Official title:

Outcomes Following Tourniquet and Non-Tourniquet Assisted Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02203045
• Other study ID #: 12-0648
• Status: Completed
• Phase: N/A
• First received: July 24, 2014
• Last updated: May 13, 2015
• Start date: October 2012

Study information

• Verified date: October 2014
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Other:
• Total Knee Arthroplasty

Locations

Country	Name	City	State
United States	Univeristy of Colorado	Aurora	Colorado
United States	Colorado Joint Replacement	Denver	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	Centura Health, Colorado Joint Replacement

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Radiographic Examination	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.	1 to 2 months post surgery	Yes
Other	Deep Vein Thrombosis Formation		48- 72 hours post operative	Yes
Other	Postoperative blood loss		48 hours post surgery	No
Other	Lower extremity edema		48- 72 hours postoperative	No
Other	Verbal analog scale pain assessment		Pre-Operative, 3 weeks and 3 months post-operative	No
Primary	Change from baseline in Quadriceps Muscle Force	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	Pre-operative, 3 weeks and 3 months post-operative	No
Secondary	Change from Baseline in Balance testing	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.	Pre-operatively, 3 weeks and 3 months post-operative	No
Secondary	Change from Baseline in Isometric Hamstring Strength		Pre-operatively, 3 weeks and 3 months post-operative	No
Secondary	Change from Baseline from Voluntary Quadriceps Activation		Pre-operative, 3 weeks and 3 months post-operative	No
Secondary	Change from Baseline in Range of Motion	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.	Pre-operatively, 3 weeks and 3 months post-operatively	No