Game Ready intermittent cryo- and cyclic compression therapy after fracture repair of the hip: a prospective multicenter study on effects on pain after surgery.

Game Ready continuous-flow cryo- and cyclic compression therapy after fracture treatment of the hip: a prospective, open-label, multicenter, randomized controlled, clinical trial on postoperative effects on pain.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29547

Enrollment

160

Registered

2013-08-27

Start date

2014-12-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip fractures, postoperative pain, cryotherapy, cyclic compression, cyrocompression Heup fractures, postoperatieve pijn, cyrotherapie, cyclische compressie, cyrocompressie

Interventions

This study intervenes with the postoperative treatment after fracture treatment for hip fracture. The intervention group ‘A’ consists of adding the Game Ready System (GRS). The Game Ready System (C

Eligibility

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 treatment and randomization. If the patient is unable to give informed consent, proxy consent must be obtained.

Exclusion criteria

Exclusion criteria: 1. Fractures at multiple foci 2. Open fracture/skin lacerations/open wounds 3. Acetabular fracture 4. (Suspicion of) concomitant malignancy 5. BMI >40 6. Preoperative osteosynthesis/prosthesis 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/cryoglobulinemia 11. Morbus Raynaud 12. Central neuromuscular disorder 13. Absent distal pulsations in the injured extremity 14. History of deep vein thrombosis 15. Patient delay >24 hrs 16. NYHA ≥ 3 17. Incapacitated individuals (IQCODE score ≥ 4.6) 18. Postoperative hemodynamic instability 19. Peroperative use of local anesthetics (LIA) or femoral blocks

Design outcomes

Primary

Measure	Time frame
The main parameter of this study is pain 24 hours postoperative measured by the numeric rating scale (NRS). Measurements will be performed during admission pre- and post GRS-treatment. The control group will have a single measurement, during the time an intervention patient would normally be treated with the GRS. Before NRS assessment patients will be asked to remain seated or prone in bed for at least 5 minutes. This ensures NRS measurement in rest.	—

Measure

Time frame

The main parameter of this study is pain 24 hours postoperative measured by the numeric rating scale (NRS). Measurements will be performed during admission pre- and post GRS-treatment. The control group will have a single measurement, during the time an intervention patient would normally be treated with the GRS. Before NRS assessment patients will be asked to remain seated or prone in bed for at least 5 minutes. This ensures NRS measurement in rest.

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Secondary

Measure	Time frame
- NRS at 48hrs, 72hrs and at outpatient visit - All used analgesics: acetaminophen, NSAID’s and morphine. All administered forms of morphine are recalculated to a single form. - Postoperative blood loss. Blood samples will be taken in which hemoglobin concentrations will be measured. - Transfusion incidence and number of transfused units. Including autologous drain reinfusion. - Incidence, severity and duration of delirium and use of psychotropic medication - Hospital admittance time: starting count at A&E arrival time. - Location and duration of rehabilitation - Functional outcome - Patient-reported health outcome o Timed up and Go test o De Morton Mobility Index o SF-12 questionnaire o EQ-5D questionnaire - Patient satisfaction - Feasibility of the Game Ready system - Complications o Cryotherapy related o General	—

Measure

Time frame

- NRS at 48hrs, 72hrs and at outpatient visit - All used analgesics: acetaminophen, NSAID’s and morphine. All administered forms of morphine are recalculated to a single form. - Postoperative blood loss. Blood samples will be taken in which hemoglobin concentrations will be measured. - Transfusion incidence and number of transfused units. Including autologous drain reinfusion. - Incidence, severity and duration of delirium and use of psychotropic medication - Hospital admittance time: starting count at A&E arrival time. - Location and duration of rehabilitation - Functional outcome - Patient-reported health outcome o Timed up and Go test o De Morton Mobility Index o SF-12 questionnaire o EQ-5D questionnaire - Patient satisfaction - Feasibility of the Game Ready system - Complications o Cryotherapy related o General

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Contacts

Public ContactN.C. Leegwater

Bonairestraat 85-2

nickleegwater@gmail.com

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)