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Tourniquet vs. no Tourniquet During Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT02907047
Recruitment Status : Completed
First Posted : September 20, 2016
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Other: tourniquet inflated Other: tourniquet not inflated Not Applicable

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Study Type : Interventional  (Clinical Trial)
Intervention Model: Parallel Assignment
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : April 1, 2017
Actual Study Completion Date : October 1, 2017

Resource links provided by the National Library of Medicine


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
No tourniquet
These subjects will not have their tourniquet inflated during key portions of the total knee arthroplasty procedure
Other: tourniquet not inflated



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02907047


Locations
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United States, Pennsylvania
Rothman Institute
Philadelphia, Pennsylvania, United States, 19148
Sponsors and Collaborators
Rothman Institute Orthopaedics
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT02907047    
Other Study ID Numbers: 16Austin01
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases