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Tourniquet and Quadricepsforce

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ClinicalTrials.gov Identifier: NCT01808859
Recruitment Status : Completed
First Posted : March 11, 2013
Last Update Posted : November 6, 2014
Sponsor:
Information provided by (Responsible Party):
Andreas Harsten, Region Skane

Brief Summary:
The purpose for this study is to investigate the quadriceps (thigh) function preoperatively and 48 hours postoperatively during knee arthroplasty (total replacement of the knee joint) in a randomised study with or without the use of a Tourniquet (cuff around the thigh during surgery) (100 mm Hg > systolic blood pressure).

Condition or disease Intervention/treatment Phase
Osteoarthritis Total Knee Arthroplasty Device: Tourniquet Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Tourniquet Use During Total Knee Arthroplasty Surgery on the Postoperative Loss of Quadricepsforce
Study Start Date : February 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: Tourniquet
The Torniquet will be inflated to 100 mmHg over systolic pressure just before skin incision. The tourniquet will be deflated when the last stich/agraf is fixed
Device: Tourniquet
hyperbaric bupivacaine 12.5-15 mg Celecoxib 400 mg and paracetamol 1 g will be given preoperatively. Postoperatively celecoxib 200 mg x 2 and paracetamol 1 g/6 h is given is given for 2 weeks.

No Intervention: No tourniquet

The patients operated on in the non-tourniquet group will have the same surgery and surgical technique but without tourniquet

hyperbaric bupivacaine 12.5-15 mg Celecoxib 400 mg and paracetamol 1 g will be given preoperatively. Postoperatively celecoxib 200 mg x 2 and paracetamol 1 g/6 h is given is given for 2 weeks.




Primary Outcome Measures :
  1. isometric quadriceps-force measured [ Time Frame: pre operatively and 48 hrs post op ]

    isometric quadriceps-force measured in an isokinetic dynameter (Biodex III). The patient is sitting in the dynameter-chair with 60° knee-flexion. After a pretest training, instruction and two suboptimal trials, the patient will do 5 maximal isometric knee-extensions.

    The highest value measured will be expressed as the quadriceps-force in Nm/Kg bodyweight [1]. The knee circumference will be measured 1 cm proximal to the base of the patella with the patient relaxed in the supine position and the knee extended [13] The Quadriceps circumference will be measured 10 cm proximal to the base of the patella with the patient in supine position and the knee extended.



Secondary Outcome Measures :
  1. Pain [ Time Frame: pre opertively and 48 hrs post op ]
    Pain at rest and pain during the isometric test will be measured by a VAS scale


Other Outcome Measures:
  1. The bloodloss [ Time Frame: within 30 min after end of surgery ]
    The bloodloss will be measured and the Hb will be compiled before and after surgery. The number of transfusions will be registered.

  2. length of hospital stay [ Time Frame: the time att which surgery ends untill the time of discharge ]
    LOS (length of stay) will be compiled.



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Ages Eligible for Study:   41 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients > 40 < 80 years planed for a total knee arthroplasty The patient will be given a written informed consent to participate in this clinical investigation.

The patient understand the clinical investigation and will cooperate with the investigational team

Exclusion Criteria:

  • Preoperatively <90 flexion, > 10 extensionsdeficit. Rheumatoid arthritis, other forms of inflammatory disease or autoimmune disorders Immunosuppresed patient Systemic corticosteroid used in previous 6 month Previous major knee surgery as osteotomy, knee related fractures, BMI<35 Diabethic neuropathy Preopratively opiod or garbabentine treatment Psychiatric disorders Planed for simultaneous bilateral knee arthroplasty

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): NCT01808859


Locations
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Sweden
Dept Orthopedic surgery, Hässleholm Hospital
Hässleholm, Skane, Sweden, 281 25
Sponsors and Collaborators
Region Skane

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Andreas Harsten, M.D., Region Skane
ClinicalTrials.gov Identifier: NCT01808859     History of Changes
Other Study ID Numbers: Biodex2013
First Posted: March 11, 2013    Key Record Dates
Last Update Posted: November 6, 2014
Last Verified: November 2014

Keywords provided by Andreas Harsten, Region Skane:
Total Knee Arthroplasty
Thigh Tourniquet

Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Celecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action