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Fast Track Recovery Knee Arthroplasty Project (FARP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01551017
Recruitment Status : Unknown
Verified April 2015 by Medical University of Graz.
Recruitment status was:  Recruiting
First Posted : March 12, 2012
Last Update Posted : April 22, 2015
Information provided by (Responsible Party):
Medical University of Graz

Brief Summary:

Fast Track Recovery Arthroplasty Project is supposed to analyse a new medical method to accelerate patient's remobilisation process after total knee endoprostheses. The method, called c-treatment, is a computer-controlled cryotherapy (soothing cooling therapy) at which the device measures temperature at the affected site (the operated knee in the investigators investigation) and optimizes the cooling temperature. The optimized cooling therapy is supposed to reduce swelling and postoperative pain whereby patient's postoperative mobilization can be done earlier leading to a reduction of length of hospitalization.

To verify c-treatment's efficiency compared to conventional cryotherapy, patients are split in a test group and a standard group. The standard group is treated following the standard protocol at the Department of Orthopaedics Surgery Graz using cold packs (Fa. Dahlhausen, product code Patient's in the test group receive c-treatment therapy following the study protocol.

All patients are instructed to fill in standardized questionnaires to evaluate social scores and pain scores preoperative as well as postoperative. The knee's swelling and range of motion as well as blood parameters monitoring the healing process are measured following the study protocol.

The comparison of these parameters between the standard and the test group is supposed to verify c-treatment's efficiency.

Condition or disease

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Postoperative Cryotherapy: Fast Track Recovery Knee Arthroplasty Project
Study Start Date : December 2011
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : December 2016

test group
standard cooling
comparison group

Primary Outcome Measures :
  1. swelling [ Time Frame: preoperative, 2, 4 and 6 days postoperative ]

    Change in swelling

    swelling is measured ad the midpatellar line as well as seven centimeters distal and seven centimeters proximal of the midpatellar line.

    swelling is measured in centimeters using a standardised measuring tape

Secondary Outcome Measures :
  1. Range of motion [ Time Frame: preoperative, 2,4 and 6 days postoperative ]

    Change in Range of motion

    Range of motion is measured with a goniometer using the Neutral position method and compared to previous measured values.

  2. Pain [ Time Frame: preoperative, 2,4 and 6 days postoperative ]

    Change in pain

    pain is evaluated using the Visual Analogue Scale (VAS). The evaluated pain scores are compared to previous pain scores

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients receiving a total knee endoprosthesis at the Department of Orthopaedics Surgery Graz

Inclusion Criteria:

  • degenerative or posttraumatic gonarthrosis or osteonecrosis around the knee
  • scheduled operation for total knee endoprosthesis
  • age between 18 and 90 years
  • patient agrees with study design, therapy and postoperative controls
  • education form is signed by patient and physician

Exclusion Criteria:

  • Body Mass Index greater than 40
  • varus or valgus deformity greater than 10 degrees
  • impaired extension greater than 10 degrees
  • flexion preoperative less than 90 degrees
  • cold urticaria
  • cryoglobulinemia
  • paroxysmal cold hemoglobinuria
  • current fracture around the knee
  • current infection or status post infection
  • rheumatoid arthritis at knee
  • tumor around the knee
  • any operations done around the knee except arthroscopic knee surgery
  • active systemic infection (HIV, HBV, HCV)
  • obstructive sleep apnea
  • opioid intolerance
  • incompliance concerning patient controlled analgesia
  • cold allergy or cold intolerance
  • Raynaud's Disease
  • circulatory disorder at the affected leg
  • fibromyalgia or other chronic pain syndromes
  • taking of immune modulating medication as cortisone, interferon or similar
  • depression or anxiety disorder
  • addicted to drugs or alcohol
  • pregnancy or possible pregnancy without adequate contraception
  • no signed education form
  • unsoundness of mind

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 identifier (NCT number): NCT01551017

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Contact: Mathias Glehr, MD +43/316 385 81756

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Department of Orthopaedics Surgery Graz - Medical University Graz Recruiting
Graz, Austria, 8020
Contact: Mathias Glehr, MD    +43/316 385 81756   
Sponsors and Collaborators
Medical University of Graz
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Principal Investigator: Mathias Glehr, MD Medical University of Graz

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Responsible Party: Medical University of Graz Identifier: NCT01551017    
Other Study ID Numbers: FARP24-214
First Posted: March 12, 2012    Key Record Dates
Last Update Posted: April 22, 2015
Last Verified: April 2015
Keywords provided by Medical University of Graz:
total knee endoprostheses