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Completed

NCT Number: NCT02907047

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rothman Institute

Philadelphia, Pennsylvania, 19148, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

tourniquet inflated

Other

tourniquet not inflated

Other

Primary outcomes

  1. timed up and go (TUG) score

    Time frame: 4 weeks following surgery

  2. Stair Climb test

    Time frame: 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

  3. Visual Analog Scale: Pain

    Time frame: in hospital (usually less than 2 days), 4 weeks post-op, 6 months post-op

Secondary outcomes

  1. blood loss

    Time frame: intra-operative

    calculated blood loss determine by hemoglobin dilution

  2. surgical field visualization

    Time frame: intra-operative

    subjective rating provided by the surgeon

  3. range of motion

    Time frame: in hospital (usually less than 2 days), 4 weeks post-op, 6 months post-op

    measured, in degrees, using a goniometer

Sponsors and collaborators

Lead sponsor

Rothman Institute Orthopaedics

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 20, 2016
Registry last updated
Jul 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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