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| Sponsor: | Hospital for Special Surgery, New York |
|---|---|
| Collaborator: |
University of Massachusetts, Worcester |
| Information provided by (Responsible Party): | Hospital for Special Surgery, New York |
| ClinicalTrials.gov Identifier: | NCT01333969 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Total Knee Arthroplasty Ischemic Preconditioning Postoperative Pain |
Procedure: Ischemic Preconditioning |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Health Services Research |
| Official Title: | The Effect of Ischemic Preconditioning on Postoperative Pain After Total Knee Arthroplasty, a Randomized, Controlled Trial |
| Estimated Enrollment: | 60 |
| Study Start Date: | April 2011 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 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).
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Procedure: 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.
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No Intervention: Control
In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.
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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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Pamela M Shaw, BS | 2127742964 | shawp@hss.edu |
| United States, New York | |
| Hospital for Special Surgery | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Pamela Shaw, BS 212-774-2964 shawp@hss.edu | |
| Contact: Daniel Yoo, MB 646-797-8948 yood@hss.edu | |
| Principal Investigator: Stavros G Memtsoudis, MD,PhD | |
| Principal Investigator: | Stavros G. Memtsoudis, MD, PhD | Hospital for Special Surgery, New York |
More Information
| Responsible Party: | Hospital for Special Surgery, New York |
| ClinicalTrials.gov Identifier: | NCT01333969 History of Changes |
| Other Study ID Numbers: | HSS10131 |
| Study First Received: | April 11, 2011 |
| Last Updated: | December 5, 2011 |
| Health Authority: | United States: Institutional Review Board |
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Ischemia Pain, Postoperative Pathologic Processes |
Postoperative Complications Pain Signs and Symptoms |