Tourniquet and Quadricepsforce
Condition: Osteoarthritis; Total Knee Arthroplasty
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The purpose for this study is to investigate the quadriceps (thigh) function preoperatively
      and 48 hours postoperatively during knee arthroplasty (total replacement of the knee joint)
      in a randomised study with or without the use of a Tourniquet (cuff around the thigh during
      surgery) (100 mm Hg > systolic blood pressure).
    

Detailed description: 
      Introduction It is established that knee arthroplasty generate a loss of 60-80 %
      quadriceps-force during the first 2-3 days postoperatively [1-4]. This can reduce the
      postoperative rehabilitation and walking function. There is, due to this fact, an increased
      interest in analysing the mechanism behind this quadriceps weakness [5].

      One of the mechanism behind this could be the routinely used - but not evidence based -
      application of an intra operative tourniquet. Several studies, including reviews and
      meta-analysis show that the use of blood less field is debatable and can be one reason for
      localised muscle necrosis and increased pain. The use of a tourniquet and the effect on the
      total perioperative blood loss is doubtful [6-11].

      The use of a tourniquet or not has no effect on the prosthetic fixation to the bone
      (Molt/STL) The influence on the late (>2 weeks) quadriceps function and rehabilitation is
      even debatable.

      [6-11], but there is no investigation on the effect of the use of a tourniquet on the early
      significant loss of quadriceps-function.

      The purpose for this study is to investigate the quadriceps function preoperatively and 48
      hours postoperatively during knee arthroplasty in a randomised study with or without the use
      of a Tourniquet (100 mm Hg > systolic blood pressure).

      Methods

      Design:

      This is a randomised controlled blinded clinical study (unless for the surgeon) in two arms -
      1) TKA operated on with the use of a Tourniquet, and 2) without the use of Tourniquet during
      surgery.

      All effect measures are compiled preoperatively and at 48 hours postoperatively. Even at the
      2 weeks and 2 month follow up the effect measures will be compiled?

      Inclusion Inclusion criteria patients > 40 < 80 years planed for a total knee arthroplasty
      The patient will be given a written informed consent to participate in this clinical
      investigation.

      The patient understand the clinical investigation and will cooperate with the investigational
      team

      Exclusion criteria Preoperatively <90 flexion, > 10 extensionsdeficit. Rheumatoid arthritis,
      other forms of inflammatory disease or autoimmune disorders Immunosuppressed patient Systemic
      corticosteroid used in previous 6 month Previous major knee surgery as osteotomy, knee
      related fractures, BMI<35?? Diabetic neuropathy Preoperatively opioid or garbabentin
      treatment Psychiatric disorders Planed for simultaneous bilateral knee arthroplasty

      Should we do bilaterally Biodex/quadriceps investigation, i.e a "controlled" leg????

      The surgical procedure All patients will be operated on using the Triathlon knee system
      without a patella component. The Tourniquet will be inflated to 100 mmHg over systolic
      pressure just before skin incision. The tourniquet will be deflated when the last stich/agraf
      is fixed. The patients operated on in the non-tourniquet group will have the same surgery and
      surgical technique.

      The incision will be equal for all patients, a straight skin incision and a paramedial
      quadriceps incision with eversion of the patella.

      The blood loss will be compiled The preoperative Hb and Hb at 48 hours will be compiled

      Perioperatively all patients will receive 150 m LIA [12]. The patients will be mobilised
      during the first 2 hours postoperatively.

      Parameters

      Primary parameter:

      isometric quadriceps-force measured in an isokinetic dynameter (Biodex III). The patient is
      sitting in the dynameter-chair with 60° knee-flexion. After a pretest training, instruction
      and two suboptimal trials, the patient will do 5 maximal isometric knee-extensions.

      The highest value measured will be expressed as the quadriceps-force in Nm/Kg bodyweight [1].
      The knee circumference will be measured 1 cm proximal to the base of the patella with the
      patient relaxed in the supine position and the knee extended [13] The Quadriceps
      circumference will be measured 10 cm proximal to the base of the patella with the patient in
      supine position and the knee extended.

      Pain at rest and pain during the isometric test will be measured by a VAS scale [1].

      The bloodloss will be measured and the Hb will be compiled before and after surgery. The
      number of transfusions will be registered.

      Length of stay will be compiled. The time from surgery to the first mobilisation will be
      measured

      Number of patients 64 patients will be included in this study by allocation to +/- Tourniquet
      (100 mm Hg > systolic blood pressure), 32 patients in each group. The power calculation is
      based on earlier data on the loss of knee extension force after a total knee arthroplasty
      [1]. With a loss of 40% muscle force (0.3 Nm/kg) without Tourniquet and a type I error of 5 %
      (p < 0,05) and a type II error of 20% (80% power) it is calculated that 58 patients should
      included be. To compensate for dropouts 64 patients will be included in this study.
    

Intervention name(s): Tourniquet
Intervention type(s): Device
Intervention description(s): hyperbaric bupivacaine 12.5-15 mg Celecoxib 400 mg and paracetamol 1 g will be given preoperatively. Postoperatively celecoxib 200 mg x 2 and paracetamol 1 g/6 h is given is given for 2 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Total Knee Arthroplasty; Thigh Tourniquet