Ischemic Preconditioning in Total Knee Arthroplasty

NCT ID: NCT01333969

Last Updated: 2024-12-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-04-30

Brief Summary

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.

Detailed 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.

Conditions

Total Knee Arthroplasty; Ischemic Preconditioning; Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Ishcemic Preconditioning

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).

Group Type: ACTIVE_COMPARATOR

Ischemic Preconditioning

Intervention Type: PROCEDURE

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

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ischemic Preconditioning

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Massachusetts, Worcester

OTHER

Sponsor Role: collaborator

Hospital for Special Surgery, New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stavros G. Memtsoudis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

Hospital for Special Surgery

New York, New York, United States

Countries

United States

References

Memtsoudis SG, Stundner O, Yoo D, Gonzalez Della Valle A, Boettner F, Bombardieri AM, Jules-Elysee K, Poultsides L, Ma Y, Sculco TP. Does limb preconditioning reduce pain after total knee arthroplasty? A randomized, double-blind study. Clin Orthop Relat Res. 2014 May;472(5):1467-74. doi: 10.1007/s11999-013-3106-4.

Reference Type: RESULT

PMID: 23761178 (View on PubMed)

Other Identifiers

2012-038

Identifier Type: -

Identifier Source: org_study_id