The goal of the study is whether to establish if application of combined cyrocompression therapy directly postoperative after hip fracture surgery results in a significant reduction in painperception en whether this reduces the morfine consumption.…
ID
Source
Brief title
Condition
- Procedural related injuries and complications NEC
- Fractures
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primairy outcome is 11-point numeric rating scale (NRS painscore) at 24 hours
after surgery.
Secondary outcome
- 48 hours postoperative NRS painscore
- 72 hours postoperative NRS painscore
- Total morphine consumption; measured by recalculating all the administered
morphine to one form (e.g. Oramorph)
- Postoperative bloodloss measured by hemoglobin values preoperative, at day 1
and day 3
- The necessity for transfusion of erythrocyte concentrate
- Admission time (in hours)
- Functional outcome at 6 weeks measured by the Timed Up and Go Test and the
Morton Mobility Index
- Self-assessed health outcome (EQ-5D en SF-12)
- Complications (DVT, infection, early aseptic loosening of the prosthesis)
- User-friendliness of the GRS
- Incidence of delirium and use of psychotropic medication
- Rehabilitation location (home/rehabilitation clinic) and duration
- Thermodynamic properties of applied therapy (optional)
Background summary
Because of the aging population hip fracture incidence is steadily rising and
will continue to rise for the years to come.
Hip fracture surgery is typically situated in the acute setting. Because of
this, patients already lost blood due to fracture-site bleeding and possibly to
soft tissue damage. This will result in a preoperative drop in hemoglobin.
Postoperative pain, further blood loss and wound discharge are unfavorable
factors that can delay recovery. There is evidence that cryo- and
compressiontherapy can minimize these setbacks. However these two modalities
have not been administered simultaneously. A relatively new system called the
Game Ready System combines these two treatments. The system is being used in
sports for quite some time with good results. Because of this, we conducted a
pilot study to evaluate the postoperative effects of the Game Ready after total
hip arthroplasty for end-stage osteoarthritis. Treated patients appeared to
have less pain, less postoperative blood loss and a trend was observed towards
less morphine consumption. Because hip fracture surgery and total hip
arthroplasty are similar types of surgery we expect these positive results also
to be applicable to the former. Since patients who fractured their hip already
lost a substantial amount of blood and a related inflammation has already
occurred the results might even be more beneficial.
Study objective
The goal of the study is whether to establish if application of combined
cyrocompression therapy directly postoperative after hip fracture surgery
results in a significant reduction in painperception en whether this reduces
the morfine consumption. Secondly postoperative blood loss, delirium incidence
and functional outcome is compared between groups. Furthermore an estimation is
made about the penetration of applied therapy.
Study design
This is an open-label, parallel, multicenter prospective randomized clinical
trial where patients will be included in the ER of 5 different hospitals (7
departments). After surgery patients will be randomized. GR treatment will
commence six hours after surgery up till 4 times daily during the first 72
hours postoperatively.
After this treatment ends and patients will be followed up until 6-weeks in the
outpatient clinic.
On this regular outpatient clinic visit both the functional and self-assessed
health outcomes are tested. Complications will be assessed aswel.
Optionally patients admitted to the Spaarne Gasthuis can choose to participate
in additional measurements with which an estimation can be made of the
penetration of applied cryotherapy.
Intervention
The only intervention consists of the postoperative application of the Game
Ready treatment.
This is a commercially available machine which combines cyro- and compression
therapy into one.
The machine has 4 pressure settings; no pressure, low pressure (5-15 mmHg),
medium pressure (5-50 mmHg) and high pressure (5-75 mmHg)
The temperature can also be adjusted between 4,0°C and 10,0°C with 3 settings.
We will use the lowest temperature setting corresponding with a minimum
temperature of 4,0°C, if tolerated by patients.
GR treatment will commence 6 hours after surgery. Initially we will start with
the lowest pressure setting. The following treatments the pressure will be
increased to maximum, if tolerated by patients.
In total patients will be treated 4 times daily in 72 hours.
Study burden and risks
Given the fact that ice-water is used temperature can never fall below 0 °C.
Because of this, it is theoretically unlikely to suffer frost injury. This was
not observed in our pilot study, literature reports a complication risk of
0.0025%.
Patients allocated to the intervention group will be asked to fill in the
satisfaction questionnaire which the control group will not have to fill in.
During treatment intervention patients are required to stay in bed. However
control patients are required to do the same around the moment of measurements
for standardization purposes.
The questionnaires and functional tests which have to be completed will be
administered during the regular outpatient clinic visits, no additional
appointments will be made.
The intervention group might benefit from the application of the GR and have
less pain, blood loss, morfine consumption and delirium incidence.
In summary we conclude that this study will have a minimum risk and burden for
patients in the control- and intervention group alike. The intervention group
is expected to benefit from treatment.
Willing patients will receive 3 skin thermometers on their legs (2 ipsilateral,
1 contralateral). The measurements will take place overnight (start at 21:30
h), the burden for the patients is that they have 3 lines in situ during their
sleep. For the duration of the measurements it is important that they stay in
bed (minimal muscle activity), if a toilet visit for instance is needed the
lines can be unplugged. Measurements take 5 hours, if the patient is asleep
after this time he/she will not be awakened but the thermometers will be
removed at the patients convenience.
Spaarnepoort 1
Hoofddorp 2134 TM
NL
Spaarnepoort 1
Hoofddorp 2134 TM
NL
Listed location countries
Age
Inclusion criteria
- Patients with intra- or extracapsular hip fracture in need for total hip-, hemiarthroplasty, intramedullary nailing, a dynamic hip screw or canullated screws.
- Older than 18 years
- Able and willing to give informed consent prior to GRS treatment and randomization.
Exclusion criteria
1) Fractures at multiple loci
2) Open fracture/skin lacerations/open wounds
3) Acetabular fracture
4) (Suspicion of) concomitant malignancy
5) BMI >40
6) Preoperative osteosynthesis materials in situ in the ipsilateral leg above knee level
7) Unable or unwilling to give informed consent by proxy
8) Morphine allergy or dependence
9) ASA 4
10) Cold hemoglobinuria/cryoglobulinaemia
11) Morbus Raynaud
12) Central neuromuscular disorder
13) Absent distal pulsations in the injured extremity (vascular impairment)
14) Active deep vein thrombosis or suspected pulmonary embolism
15) Patient delay >24 hrs
16) NYHA * 3
17) Only if the clinician has doubts about the cognitive state of the subject can the IQCODE be administered, if the IQCODE score * 4.6 is will the subject be excluded
18) Postoperative hemodynamic instability
19) Use of local anaesthetics (LIA) or long-acting femoral blocks
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL45657.094.14 |