Fast Track Recovery Knee Arthroplasty Project (FARP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Medical University of Graz.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01551017
First received: March 8, 2012
Last updated: September 13, 2012
Last verified: September 2012

March 8, 2012
September 13, 2012
December 2011
Not Provided
swelling [ Time Frame: preoperative, 2, 4 and 6 days postoperative ] [ Designated as safety issue: No ]

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

Same as current
Complete list of historical versions of study NCT01551017 on ClinicalTrials.gov Archive Site
  • Range of motion [ Time Frame: preoperative, 2,4 and 6 days postoperative ] [ Designated as safety issue: No ]

    Change in Range of motion

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

  • Pain [ Time Frame: preoperative, 2,4 and 6 days postoperative ] [ Designated as safety issue: No ]

    Change in pain

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

Same as current
Not Provided
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Fast Track Recovery Knee Arthroplasty Project
Postoperative Cryotherapy: Fast Track Recovery Knee Arthroplasty Project

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 93.000.00.042). 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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample

Patients receiving a total knee endoprosthesis at the Department of Orthopaedics Surgery Graz

Swelling
Not Provided
  • c-treatment
    test group
  • standard cooling
    comparison group

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
Not Provided
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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
Both
18 Years to 90 Years
No
Contact: Mathias Glehr, MD +43/316 385 81756 mathias@glehr.com
Austria
 
NCT01551017
FARP24-214
No
Medical University of Graz
Medical University of Graz
Not Provided
Principal Investigator: Mathias Glehr, MD Medical University of Graz
Medical University of Graz
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP