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Total Knee Arthroplasty - Accelerated Recovery Without Tourniquet

This study is currently Recruiting

August 2011 By Northern Orthopaedic Division, Denmark

First Recieved on January 14, 2011

Last Updated on August 2, 2011

Sponsor: Northern Orthopaedic Division, Denmark
Collaborators:
Information provided by: Northern Orthopaedic Division, Denmark
Identifier: NCT01309035

Purpose

Introduction: Approximately 7000 total knee replacements (TKAs) are done every year. More than 90% of these knee replacements are performed with the use of bone cement. Traditionally, a tourniquet has been, used to reduce the bleeding during surgery, enabling surgeons to perform delicate dissections in a bloodless operative field. A tourniquet can be defined as a constricting or compressing device used to control temporarily venous and arterial circulation to an extremity. Pressure is applied circumferentially on the skin and underlying tissues of a limb. This pressure is transferred to the walls of vessels, causing them to become occluded. It is well known that applying a tourniquet for more than 1 to 2 hours is associated with a number of disadvantages, for instance, severe pain and muscle effects during the first postoperative day, thereby slowing rehabilitation. Other side effects related to tourniquet use, include pulmonary embolus caused by venous thrombosis and arterial thrombosis as a result of the dislodgement of an arterial plaque. Furthermore, tourniquet-induced hypertension with general anaesthesia, muscle injury, a wide spectrum of neurologic injuries, and tissue changes (Oedema compartment syndrome, post-tourniquet syndrome) have been reported. An important fact is that bleeding affects the quality of binding between bone and cement and thereby fixation of the knee prosthesis? Since the introduction of modern cementing techniques, no previous clinical studies have investigated the advantages or disadvantages of tourniquet use in knee replacement surgery. Aims/hypothesis of the study: 1. To investigate the advantages and disadvantages of tourniquet use, including whether not using a tourniquet reduces pain, facilitates mobilisation and recovery, and shortens length of stay. 2. To study whether use of a tourniquet affects leg muscles during and after surgery, as measured by with use of microdialysis to quantify level of ischemia . 3. To determine whether prosthesis fixation, measured by RSA, is affected by tourniquet use. Because third generation cements secure prosthesis fixation, the investigators do not expect to find any clinically significant migration (less than 2 mm) 2 years after surgery. Perspectives: The investigators hope that the results of our study will improve rehabilitation regimes so that patients will experience less pain after surgery and thus achieve more rapid mobilisation and return to their daily lives.

Study Type: Interventional
Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:50 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

Inclusion Criteria: - Patients with symptomatic and radiographic verified knee symptoms, selected for primary unilateral total knee joint replacement (TKR) - Age 50 and above (not older than 85) - BMI < 35 and height >160 cm - No severe cardiovascular conditions - No previously knee surgery done in the same knee - Oral and written acceptance Exclusion Criteria: - Severe obesity - rheumatic diseases - Absense of pulse in foot - Diabetes - Previuos operation in concerning knee - Lack of informed consent or ability to read / understand Danish

Investigators

Locations

  • Northern Orthopaedic Division, Klinik Farsoe and Aarhus University Hospital

    Farsoe, Northern Jutland Denmark

Conditions related to this trial:

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