Postoperative Cryotherapy: Fast Track Recovery Knee Arthroplasty Project
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- swelling
Study Overview
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.
Detailed Description
OBJECTIVES
The purpose of this prospective, randomized, single-blind, comparative and controlled clinical study was to evaluate a new cryotherapy device, the cTreatment® system (Waegener®, Belgium) consisting of the Cryoceutical Treatment Server 100 series (CTS) and the Cryoceutical Treatment Pad (cPad®), in comparison to the standard cooling protocol, which was the cold packs (cold/hot pack, Dahlhausen®) currently used at the Department of Orthopaedic Surgery of the Medical University of Graz, Austria, in patients undergoing primary and unilateral TKA surgery. It was particularly focused on the device's efficiency in terms of eventual improvements in the patient's postoperative rehabilitation and mobilisation, such as positive alterations of knee ROM and NRS pain scale, which were set as primary objectives. Further contributing elements, such as alterations of the analgesic consumption, knee girth and the device's safety were set as secondary objectives.
METHODS
Subjects between 18 and 90 suffering from severe degeneratively or traumatically caused gonarthritis or gonarthrosis of the knee joint scheduled for endoprothetic treatment with TKA could be included when giving their informed consent. Exclusion criteria particularly included, on the one side, reasons, which might interfere with the patients' statistical comparability regarding the outcome, such as severe pre-existing local and systemic conditions others than gonarthritis and foregone surgical interventions others than arthroscopy. On the other side it contained conditions, which would interfere with the planned study design, for instance, the standardized medication and PCA and long cooling intervals during hospitalisation.
After giving their written consent they were further randomized to the cryotherapy group, receiving the cTreatment®, or the standard group, receiving cold pack application. Therefore a web-based programme, the "Randomizer", was used (23), considering the patient's sex and scheduled design type of endoprostheses to be implanted, which was either the PFC® or the LCS® (both from DePuy®, Warsaw, IN, USA) endoprosthesis.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Pain(preoperative, 2,4 and 6 days postoperative)
- Range of motion(preoperative, 2,4 and 6 days postoperative)