Nanoneedle

• Research type

  Research Study

• Full title

  Prospective Evaluation of nanoneedle - Part 1 (Ankle Syndesmosis Injury)

• IRAS ID

  320825

• Contact name

  Robin Elliot

• Contact email

  robin.elliot@hhft.nhs.uk

• Sponsor organisation

  Hampshire Hospitals NHS Foundation Trust

• ISRCTN Number

  ISRCTN11167914

• Duration of Study in the UK

  1 years, 3 months, 29 days

• Research summary

  Research Summary:
  The study aims to evaluate the Nanoneedle to assess unstable ankle syndesmosis injuries, compared with the current gold standard assessment which is arthroscopy, including ease of application, and diagnostic accuracy.
  No previous studies have evaluated the Nanoneedle for syndesmosis injury assessment. This technology potentially reduces the rate of nerve injury when compared with standard arthroscopy due to the smaller size of the instrumentation.

  In future it could be performed in the outpatient setting under local anaesthetic, allowing dynamic intraarticular joint assessment, and may reduce the need for MRI.
  This study will provide new useful information for patient clinical benefit, and the surgeons.

  Lay summary of study results: This prospective evaluation demonstrates that NanoNeedle camera arthroscopy provides useful assessment of acute syndesmosis injuries, with diagnostic performance that closely parallels the gold standard of ankle arthroscopy. In this cohort of 20 participants, Nanoneedle camera assessment enabled a definitive determination of syndesmotic stability in 90% of cases, indicating that the technology is capable of addressing the key diagnostic question in the majority of acute ankle injuries where syndesmotic instability is suspected.

• REC name

  Yorkshire & The Humber - Bradford Leeds Research Ethics Committee

• REC reference

  23/YH/0094

• Date of REC Opinion

  28 Apr 2023

• REC opinion

  Further Information Favourable Opinion