Fast Track Recovery Knee Arthroplasty Project (FARP)
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Postoperative Cryotherapy: Fast Track Recovery Knee Arthroplasty Project|
- 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
- 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
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01551017
|Contact: Mathias Glehr, MD||+43/316 385 email@example.com|
|Department of Orthopaedics Surgery Graz - Medical University Graz||Recruiting|
|Graz, Austria, 8020|
|Contact: Mathias Glehr, MD +43/316 385 81756 firstname.lastname@example.org|
|Principal Investigator:||Mathias Glehr, MD||Medical University of Graz|