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Tourniquet vs. no Tourniquet During Total Knee Arthroplasty

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02907047
Enrollment
Unknown
Registered
2016-09-20
Start date
2016-06-01
Completion date
2017-10-01
Last updated
2019-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Brief summary

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

Interventions

OTHERtourniquet not inflated
OTHERtourniquet inflated

Sponsors

Rothman Institute Orthopaedics
Lead SponsorOTHER

Study design

Intervention model
PARALLEL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
timed up and go (TUG) score4 weeks following surgery
Stair Climb testin hospital (usually less than 2 days), 4 weeks post-op, 6 months post-optime, in seconds, to climb one flight of nine stairs
Visual Analog Scale: Painin hospital (usually less than 2 days), 4 weeks post-op, 6 months post-op

Secondary

MeasureTime frameDescription
blood lossintra-operativecalculated blood loss determine by hemoglobin dilution
surgical field visualizationintra-operativesubjective rating provided by the surgeon
range of motionin hospital (usually less than 2 days), 4 weeks post-op, 6 months post-opmeasured, in degrees, using a goniometer

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026