broken hip hip fracture
Conditions
Interventions
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 mach
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
Sponsors
Spaarne Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Primairy outcome is 11-point numeric rating scale (NRS painscore) at 24 hours after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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) | — |
Countries
Netherlands
Outcome results
None listed