Swelling Clinical Trial
Official title:
Postoperative Cryotherapy: Fast Track Recovery Knee Arthroplasty Project
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.
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.
After being randomized to the therapy group patients were assigned to the locally applied
cryotherapy treatment by use of the cTreatment® system until the end of the clinical study,
which was set for POD six. That implied the first cooling session to the extent of one hour
already preoperatively on the first preoperative day (PreOD), which coincidently was the day
of admission throughout all cases. Furthermore, the subjects received cryotherapy
immediately after TKA in the postanaesthesia care unit for six hours in total. During the
in-patient setting until POD six the cTreatment® was applied each day for four hours in
total, divided into two hours in the morning and two hours in the afternoon. Also there was
the option to use the cTreatment® in terms of additional analgesia in the evening for up to
four hours on each POD.
PreOD 1 TKA POD 1 POD 2 POD 3 POD 4 POD 5 POD 6
- 1 h pre-OP 6 h post-OP
4 h optional 2 h morning
2 h afternoon
4 h optional 2 h morning
2 h afternoon
4 h optional 2 h morning
2 h afternoon
4 h optional 2 h morning
2 h afternoon
4 h optional 2 h morning
2 h afternoon
4 h optional 2 h morning
2 h afternoon
4 h optional Table 1: cTreatment® protocol in therapy group
According to the manufacturer, the CTS is a class IIa medical device, which
thermodynamically exchanges heat controlled by a built-in computer. It is able to regulate
both the flow rate and the fluid's temperature reaching the cPad®. The CTS is operated by
use of a touch screen, which allows to start, pause, resume and stop a cooling session.
According to the instruction manual the cPad®, which is connected to the Server with
flexible tubes using anti-reflux design, is made of flexible Polyurethane, latex free and
hypoallergenic. Using hook and loop fasteners it is easy to wrap around the knee ensuring a
maximum of contact surface.
The control group was treated abiding by the standard cryotherapy regimen at the Department
of Orthopaedic Surgery including the usage of common cold packs (cold/hot pack,
Dahlhausen®). They did not receive any cryotherapy before the surgical intervention
corresponding to the standard regimen. After TKA cold packs were applied three times per day
for 20 minutes each throughout the whole trial. In the context of blinding, the cold packs
were placed beneath the applied cPads® in subjects randomized to the standard group, in
order to account for a subjectively experienced cold as the CTS was turned off. Besides
that, the study setting was identical in both groups.
For the purpose of a better comparability all participating patients received general
anaesthesia and a postoperative analgetic therapy based on patient controlled analgesia
(PCA), which was filled with diluted hydromorphone, accounting for 0,2 mg hydromorphone per
single dose. In addition to that, exclusively Novalgin® 4 x 1 g was administered as a
non-opiate analgesic. The PCA was removed after 72 hours postoperative.
The performed physical measurements consisted of the quantification of the knee girth and
the ROM of the treated knee joint. The measurements concerning the knee girth were performed
at three different levels, at middle-patella, 7 centimetres proximal of the patellar base
and 7 centimetres distal of the apex patellae. The ROM was evaluated by use of a hand-held
goniometer and the patient being in a supine position. Among the non-physical evaluations
was verbally assessing the subjectively experienced pain intensity by use of the
eleven-point numeric rating scale (NRS) pain score, about which each patients was told that
zero was equal to "no pain at all" and ten was equal to "strongest pain imaginable". The NRS
was always evaluated for the state of absolute rest and the state of motion. In this
relation the more objectively evaluable analgesics consumption was recorded. Therefore the
total hydromorphone usage administered by use of PCA after 72 hours was noted. The physical
examinations of the knee joint's ROM and girth and the NRS score evaluation were performed
on admission day and POD two, four and six. In the course of the regular change of dressings
during the medical rounds the surgical area was exactly examined for potential cold-induced
local alterations. In this context, it was particularly searched for signs of frostbite,
nerve palsy, inhibited wound healing, deep vein thrombosis and infection. In case of
occurrence, the patients had also been told to immediately call attention to eventual
adverse effects related to the cold therapy, which they were preliminarily informed about.
IBM® SPSS® Statistics software version 20 was used in order to perform all statistical
analyses. In this regard descriptive statistics were conducted using basic calculations of
means, standard deviations, ranges, minima and maxima. For the comparisons between the two
study groups on admission day, POD two, four and six measured data was first checked for the
existence of normal distribution by use of Shapiro-Wilk and Kolmogorov- Smirnov tests. In
case of normal distribution, the independent-samples t-test as parametric test was
performed. If a normal distribution did not exist, the Wilcoxon-Mann-Whitney test as
non-parametric test was performed in order to obtain values of significance regarding
between-group distinctions. Throughout the statistical analyses, the level of significance,
respectively the P-value was defined as ≤ 0,05.
;
Observational Model: Case Control, Time Perspective: Prospective
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