Ischemic Preconditioning in Total Knee Arthroplasty

Hospital for Special Surgery (HSS)

Status: Completed

Conditions: Postoperative Pain; Ischemic Preconditioning; Total Knee Arthroplasty

Treatments: Procedure: Ischemic Preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT01333969

2012-038

Details and patient eligibility

About

The application of a tourniquet for 5 minutes and subsequent reperfusion before actual inflation of the tourniquet for total knee arthroplasty (ischemic preconditioning) decreases the level of local inflammation and therefore postoperative pain in response to reperfusion of the ischemic extremity.

Full description

During knee surgery your surgeon routinely uses a device called a tourniquet that allows us to temporarily cut of blood supply to the site of surgery. This helps to reduce blood loss and improves operating conditions. When allowing blood back into your leg at the end of the procedure, debris (bone, fat, tissue breakdown products and cement from the surgery) gets washed out and gains access to the rest of your body. In the vast majority of cases this event bares no major clinical consequences, but can rarely result in signs of inflammation of various body systems. Patients with evidence of impaired organ system function such as pre-existing lung and heart disease may be more vulnerable. Previous studies suggest that cutting off the blood supply for a short period of time just before a prolonged episode, could lead to a decrease in the extent of tissue breakdown products in this extremity and may thus be associated with a decrease in the inflammation of other organ systems. We propose to study this theory in knee surgery patients by looking at levels of markers of inflammation present in the blood before and after surgery.

Enrollment: 60 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients undergoing primary total knee arthroplasty

Exclusion criteria

• Patients who chronically use narcotics (<1 month).
• Patients with contraindications (severe peripheral vascular disease, presence of femoral-popliteal bypass grafts, etc.) or no plan for tourniquet use as determined by the clinical care team.
• Patients who are on corticosteroids prior to their surgery

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Ishcemic Preconditioning

Active Comparator group

Description:

In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components).

Treatment:

Procedure: Ischemic Preconditioning

Control

No Intervention group

Description:

In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.