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GEKO: Neuromuscular electrostimulation (NMES) device, pilot feasibility study looking at time to surgery study in patients requiring ankle fixation following fracture, comparison to matched retrospective controls.

The GEKO device is indicated for the prevention and treatment of oedema. The aim of the study is to show that recruiting, and performing study assessments in ankle fracture patients requiring ORIF attending James Cook University Hospital is feasible, and to obtain data to support the powering of a larger study to demonstrate the effectiveness of the GEKO device at reducing length of stay in hospital for this population of patients. The study will allow us to assess the acceptability, tolerability and compliance of treatment with the GEKO device.

 

Inclusion;

  • Aged 18- 60 years old
  • Clinically and radiographically diagnosed acute ankle fracture that, in the opinion of the treating surgeon, requires operative fixation
  • Able to understand the patient information sheet (PIS) and willing to sign the written informed consent form
  • Able and willing to follow the protocol requirements

 

Exclusion;

  • Has a pacemaker
  • Morbid Obesity (BMI index >40kg/m2)
  • Patients who on presentation to hospital are known to be pregnant
  • Clinically significant co-morbidities that need to be treated prior to surgical interventions and could therefore impact upon time to theatre
  • History or signs of previous deep or superficial vein thrombosis/ pulmonary embolism
  • Varicosities, ulceration or erosion around the area of the leg where the study device would be fitted
  • Diabetic
  • Already taking part in a clinical study, or has so within the last 8 weeks
  • None responder to GEKO device

 

Clinical Trials in Injuries and Emergencies

Select a trial from the list below to find out more about what it’s all about and how you can get involved in helping others.

Haemorrhage Alleviation with Tranexamic Acid [HALT-IT]:

The HALT-IT trial will determine the effect of early administration of tranexamic acid on mortality, morbidity (re-bleeding, non-fatal vascular events), blood transfusion, surgical intervention and health status in patients with acute gastrointestinal bleeding

CRASH-3: Tranexamic Acid for the Treatment of Significant Traumatic Brain Injury

The aim of CRASH-3 trial is to establish whether early administration of tranexamic acid reduces the rates of death, disability and vascular occlusive events in adult patients with admitted to hospital with a traumatic brain injury.

WOLLF:

This study looks at the effectiveness of Negative pressure wound therapy (NPWT) with standard dressings for the prevention of infection in patients presenting to hospital with an open fractures of the lower limb.

Patient Perceptions of Multiple Rib fracture rehabilitation:

This study aims to explore the patient perspective of the current issues surrounding recovery and rehabilitation after traumatic multiple rib fractures.

WHiTE Cohort

The aim of this study is to evaluate the use of PROMs in the context of the National Hip Fracture Audit

WHIST: Wound Healing in Surgery for Trauma. A Randomised Controlled trial of standard wound management versus negative pressure wound therapy in the treatment of adult patients having surgical incisions for major trauma to the lower limb.

The aim of the pragmatic RCT is to compare standard dressings with negative wound therapy for treatment of surgical incisions associated with major trauma of the lower limb.

WHiTE4: A randomised controlled trial of the sliding hip screw versus X-Bolt dynamic plating system for the fixation of trochanteric fractures of the hip.

To investigating the patients’ quality of life after X-Bolt (XB) Dynamic Plating System compared with the Sliding Hip Screw (SHS) in the treatment of trochanteric fracture of the hip.

UK FROST: Multi-centre randomised controlled trial with economic evaluation and nested qualitative study comparing early structured physiotherapy versus manipulation under anaesthesia versus arthroscopic capsular release for patients referred to secondary care with a frozen shoulder (Adhesive Capsulitis)

UK FROST is a multi-centre randomised controlled trial with economic evaluation and nested qualitative study comparing early structured physiotherapy versus manipulation under anesthesia versus arthroscopic capsular release for patients referred to secondary care with a frozen shoulder

GEKO: Neuromuscular electrostimulation (NMES) device, pilot feasibility study looking at time to surgery study in patients requiring ankle fixation following fracture, comparison to matched retrospective controls.

The aim of the study is to show that recruiting, and performing study assessments in ankle fracture patients requiring ORIF attending James Cook University Hospital is feasible, and to obtain data to support the powering of a larger study to demonstrate the effectiveness of the GEKO device at reducing length of stay in hospital for this population of patients.


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