Fast Track Recovery Knee Arthroplasty Project (FARP)
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|ClinicalTrials.gov 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
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|Observational Model:||Case Control|
|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|
- 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
- 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.
- 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
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): NCT01551017
|Contact: Mathias Glehr, MD||+43/316 385 firstname.lastname@example.org|
|Department of Orthopaedics Surgery Graz - Medical University Graz||Recruiting|
|Graz, Austria, 8020|
|Contact: Mathias Glehr, MD +43/316 385 81756 email@example.com|
|Principal Investigator:||Mathias Glehr, MD||Medical University of Graz|