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Completed

NCT Number: NCT02203045

Outcomes Following Tourniquet and Non-Tourniquet Assisted Total Knee Arthroplasty

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

Up to 75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univeristy of Colorado, Aurora, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total Knee Arthroplasty

Other

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Colorado Joint Replacement
  • CommonSpirit Health

Registry information

Important dates

Study start
2012
Primary completion
2014
First posted
Jul 29, 2014
Registry last updated
May 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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