Fast Track Recovery Knee Arthroplasty Project (FARP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Medical University of Graz
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
  Purpose

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
Swelling

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Postoperative Cryotherapy: Fast Track Recovery Knee Arthroplasty Project

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • 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



Secondary Outcome Measures:
  • 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



Estimated Enrollment: 80
Study Start Date: December 2011
Groups/Cohorts
c-treatment
test group
standard cooling
comparison group

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01551017

Contacts
Contact: Mathias Glehr, MD +43/316 385 81756 mathias@glehr.com

Locations
Austria
Department of Orthopaedics Surgery Graz - Medical University Graz Recruiting
Graz, Austria, 8020
Contact: Mathias Glehr, MD    +43/316 385 81756    mathias@glehr.com   
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Mathias Glehr, MD Medical University of Graz
  More Information

Publications:
Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01551017     History of Changes
Other Study ID Numbers: FARP24-214
Study First Received: March 8, 2012
Last Updated: September 13, 2012
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Graz:
total knee endoprostheses
swelling
mobilisation

Additional relevant MeSH terms:
Edema
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2014