Ischemic Preconditioning in Total Knee Arthroplasty

NCT01333969 | Completed Results DMC

• 1 other identifier: 2012-038
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty; Ischemic Preconditioning; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain at Rest and Exercise as Assessed by Visual Analogue Scale (VAS) Scores at 48h After Surgery

  Visual Analogue Scale (VAS) are used to measure the intensity of pain. The total scale ranged from 0 (no pain) to 10 (excruciating pain). The average value at POD 48hours was reported for each arm/group.

  48hrs after surgery

Secondary Outcomes (8)

• Overall Epidural Volume

  At 48hrs after surgery

• Muscle Oxygenation Over Calf at 48h After Surgery

  At 48 hrs after surgery

• Levels of Interleukin 6 (IL6) in Drainage Fluid at 24hr Postoperatively

  At 24 hours postoperatively

• Periarticular Circumference of the Knee at 6h, 24h, and 48h

  measured at 6 hours, 24 hours, and 48 hours

• Hospital Length of Stay

  Up to discharge date

Study Arms (2)

Ishcemic Preconditioning

ACTIVE COMPARATOR

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).

Procedure: Ischemic Preconditioning

Control

NO INTERVENTION

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

Interventions

Ischemic Preconditioning 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.

Ishcemic Preconditioning

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing primary total knee arthroplasty

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead
• University of Massachusetts, Worcester: collaborator

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Publications (1)

• 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.

  PMID: 23761178 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ischemic Preconditioning

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Results Point of Contact

• Title: Dr. Stavros Memtsoudis
• Organization: Hospital for Special Surgery

MemtsoudisS@hss.edu

646-797-8522

Study Officials

• Stavros G. Memtsoudis, MD, PhD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2011
• First Posted: April 12, 2011
• Study Start: April 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: December 27, 2024
• Results First Posted: September 23, 2024

Record last verified: 2024-05

Locations

US (1)