Tourniquet vs. no Tourniquet During Total Knee Arthroplasty

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Other: tourniquet inflated; Other: tourniquet not inflated

• Registration Number: NCT02907047
• Lead Sponsor: Rothman Institute Orthopaedics

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-01
• Study First Submitted: 2016-09-15
• Study First Submitted QC: 2016-09-19
• Study First Posted: 2016-09-20
• Primary Completion: 2017-04-01
• Study Completion: 2017-10-01
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-27
• Last Update Posted: 2019-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tourniquet	tourniquet inflated	These subjects will have their tourniquet inflated during key portions of the total knee arthroplasty procedure
No tourniquet	tourniquet not inflated	These subjects will not have their tourniquet inflated during key portions of the total knee arthroplasty procedure

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rothman Institute; 🇺🇸 Philadelphia, Pennsylvania, United States