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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
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
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.
||Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Resources/Links provided by NLM:
|Study Start Date:
|Estimated Primary Completion Date:
|With Tourniquet:Active Comparator|
Total Knee Arthroplasty. Surgery performed during use of a tourniquet.
Total Knee Arthroplasty. Surgery performed without use of a tourniquet.
|Procedure:Total Knee Arthroplasty|
Surgery for OA knee pains
|Ages Eligible for Study:||50 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
- 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
- Severe obesity
- rheumatic diseases
- Absense of pulse in foot
- Previuos operation in concerning knee
- Lack of informed consent or ability to read / understand Danish