Tourniquet vs. no Tourniquet During Total Knee Arthroplasty

The purpose of this study is to correlate functional outcomes and perioperative complications with tourniquet use during total knee arthroplasty.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Other: tourniquet inflated; Other: tourniquet not inflated

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19148
      • Rothman Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. All unilateral primary knee arthroplasties performed by investigators participating in this study will be eligible for inclusion
2. Diagnosis of osteoarthritis

Exclusion Criteria:

1. Revision surgery
2. Bilateral knee surgery
3. Age <18 or >80
4. BMI >40
5. Baseline lower extremity strength less than 5/5
6. Vascular calcifications
7. History of chronic narcotic use, defined as more than 5mg of oxycodone q4 hours
8. Functionally limiting spine disease
9. Other functionally limiting lower extremity disorder (i.e. symptomatic ipsilateral hip disease)
10. Patients who cannot perform the baseline functional tests
11. Allergy/contraindication to protocol medications
12. Post-traumatic arthritis
13. Inflammatory arthritis
14. Pregnancy
15. Prisoners
16. Patients receiving care as part of a worker's compensable injury

Study Plan

How is the study designed?

Design Details

• Interventional Model: Parallel Assignment

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tourniquet; These subjects will have their tourniquet inflated during key portions of the total knee arthroplasty procedure	Other: tourniquet inflated
Other: No tourniquet; These subjects will not have their tourniquet inflated during key portions of the total knee arthroplasty procedure	Other: tourniquet not inflated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
timed up and go (TUG) score		4 weeks following surgery
Stair Climb test	time, in seconds, to climb one flight of nine stairs	in hospital (usually less than 2 days), 4 weeks post-op, 6 months post-op
Visual Analog Scale: Pain		in hospital (usually less than 2 days), 4 weeks post-op, 6 months post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood loss	calculated blood loss determine by hemoglobin dilution	intra-operative
surgical field visualization	subjective rating provided by the surgeon	intra-operative
range of motion	measured, in degrees, using a goniometer	in hospital (usually less than 2 days), 4 weeks post-op, 6 months post-op

Collaborators and Investigators

• Sponsor: Rothman Institute Orthopaedics

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: September 15, 2016
• First Submitted That Met QC Criteria: September 19, 2016
• First Posted (Estimate): September 20, 2016

Study Record Updates

• Last Update Posted (Actual): July 1, 2019
• Last Update Submitted That Met QC Criteria: June 27, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 16Austin01