Fast Track Recovery Knee Arthroplasty Project

NCT01551017 | Unknown

• 1 other identifier: FARP24-214
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Swelling

Keywords

total knee endoprostheses; swelling; mobilisation

Outcome Measures

Primary Outcomes (1)

• swelling

  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

  preoperative, 2, 4 and 6 days postoperative

Secondary Outcomes (2)

• Range of motion

  preoperative, 2,4 and 6 days postoperative

• Pain

  preoperative, 2,4 and 6 days postoperative

Study Arms (2)

c-treatment

test group

standard cooling

comparison group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Department of Orthopaedics Surgery Graz - Medical University Graz

Graz, 8020, Austria

RECRUITING

Related Publications (6)

• Herbold JA, Bonistall K, Walsh MB. Rehabilitation following total knee replacement, total hip replacement, and hip fracture: a case-controlled comparison. J Geriatr Phys Ther. 2011 Oct-Dec;34(4):155-60. doi: 10.1519/JPT.0b013e318216db81.

  PMID: 22124414 BACKGROUND

• Bade MJ, Kohrt WM, Stevens-Lapsley JE. Outcomes before and after total knee arthroplasty compared to healthy adults. J Orthop Sports Phys Ther. 2010 Sep;40(9):559-67. doi: 10.2519/jospt.2010.3317.

  PMID: 20710093 BACKGROUND

• Sultan PG, Most E, Schule S, Li G, Rubash HE. Optimizing flexion after total knee arthroplasty: advances in prosthetic design. Clin Orthop Relat Res. 2003 Nov;(416):167-73. doi: 10.1097/01.blo.0000081937.75404.ee.

  PMID: 14646757 BACKGROUND

• Markert SE. The use of cryotherapy after a total knee replacement: a literature review. Orthop Nurs. 2011 Jan-Feb;30(1):29-36. doi: 10.1097/NOR.0b013e318205749a.

  PMID: 21278552 BACKGROUND

• Adie S, Naylor JM, Harris IA. Cryotherapy after total knee arthroplasty a systematic review and meta-analysis of randomized controlled trials. J Arthroplasty. 2010 Aug;25(5):709-15. doi: 10.1016/j.arth.2009.07.010. Epub 2009 Sep 2.

  PMID: 19729279 BACKGROUND

• Holmstrom A, Hardin BC. Cryo/Cuff compared to epidural anesthesia after knee unicompartmental arthroplasty: a prospective, randomized and controlled study of 60 patients with a 6-week follow-up. J Arthroplasty. 2005 Apr;20(3):316-21. doi: 10.1016/j.arth.2004.09.043.

  PMID: 15809948 BACKGROUND

Study Officials

• Mathias Glehr, MD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mathias Glehr, MD

CONTACT

+43/316 385 81756; mathias@glehr.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2012
• First Posted: March 12, 2012
• Study Start: December 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2016
• Last Updated: April 22, 2015

Record last verified: 2015-04

Locations

AU (1)