Clinical Trial: Midds Ankle Fracture
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: gekoTM Neuromuscular Electrostimulation (NMES) Device, Pilot Feasibility Study Looking at Time to Surgery Study in Patients Requiring Ankle Fixation Following Fracture, Comparison to Matched Retrospec
Brief Summary: The geko™ device is indicated for the prevention and treatment of oedema. The aim of this study is to show that recruiting, and performing study assessments in ankle fracture patients requiring surgery to fix their ankle attending the James Cook 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 for this population of patients. This study will also allow us to assess the acceptability, tolerability and compliance of treatment with the geko device.
Detailed Summary:
Sponsor: Firstkind Ltd
Current Primary Outcome:
- Feasibility to recruit n=20 ankle fracture patients in trauma setting within 4 months [ Time Frame: 4 months ]
- Time to readiness for surgery [ Time Frame: 0-~7days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Oedema reduction in prospective geko™ subjects prior to surgery, by two circumferential measures using tape measures built into the patients plaster cast [ Time Frame: 0-~7days ]
- Adverse events, including the need for secondary surgery or additional treatment, serious adverse events [ Time Frame: study duration up to ~14days ]
Original Secondary Outcome: Same as current
Information By: Firstkind Ltd
Dates:
Date Received: July 15, 2016
Date Started: July 2016
Date Completion:
Last Updated: April 12, 2017
Last Verified: July 2016
