NanoNeedle evaluation study
| ISRCTN | ISRCTN11167914 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11167914 |
| IRAS number | 320825 |
| Secondary identifying numbers | CPMS 56924, IRAS 320825 |
- Submission date
- 26/07/2023
- Registration date
- 25/09/2023
- Last edited
- 18/08/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
People who have sustained an ankle joint injury, which includes an injury to the ankle syndesmosis (a joint where two bones are held together by ligaments), are offered arthroscopic (keyhole) ankle surgery because the injury can make their ankle joint unstable. In this study, keyhole surgery will be undertaken to assess the ankle ligament injury using Nanoscope technology. The Nanoneedle™ is a part of this technology and is a new single-use chip on the tip of a camera system. The aim of the current study is to evaluate the ability of the NanoNeedle™ scope to accurately assess acute ankle syndesmosis injuries compared with standard arthroscopy. Specifically, the aims are to determine the ease of use, arthroscopic field of view and diagnostic accuracy of the NanoNeedle in diagnosing ankle syndesmosis injury and instability
Who can participate?
Adult patients aged over 18 years old with recent acute ankle syndesmosis injury and clinical or MRI evidence of instability
What does the study involve?
The procedure will be carried out under general or spinal anaesthetic, at the same time as the normal operation planned for the ankle injury. The Nanoneedle™ is placed inside the ankle joint through 1 or 2 tiny incisions to provide the surgeons with high-quality images that can be a better alternative to scans like MRIs, this will allow the surgeons to look at the syndesmosis whilst moving the ankle joint. The images will help to assess the ankle for instability and plan subsequent care.
What are the possible benefits and risks of participating?
Currently, there are long delays to investigations such as MRI and it is feasible that the Nanoneedle could be applied in an outpatient setting with the benefit of allowing dynamic assessment for instability, and therefore could reduce the burden of MRI on the NHS.
As with all operations, there is a small risk of complications, and these will be determined and recorded by the surgical team, either in the clinic or via telephone consultations. The risks of surgery will be discussed prior to the operation and the patient, will sign a standard consent form. Whether or not they agree to participate in the study will not have any effect on the development of potential surgical complications. Potential complications from this type of surgery include pain, swelling, stiffness, infection, blood clots, scar problems, nerve or vessel damage, bleeding and COVID-19. The use of the Nanoneedle will add approximately 5 minutes to the surgical time compared with standard arthroscopy and therefore does not add any significant risks to the standard surgery.
Where is the study run from?
Basingstoke & North Hampshire Hospital (UK)
When is the study starting and how long is it expected to run for?
June 2022 to December 2025
Who is funding the study?
1. Arthrex GmbH (Germany)
2. National Institute for Health and Care Research (NIHR) (UK)
Who is the main contact?
Dr Angie Dempster, Angie.dempster@hhft.nhs.uk
Contact information
Principal Investigator
Basingstoke & North Hampshire Hospital
Aldermaston Rd
Basingstoke
RG24 9NA
United Kingdom
| Phone | +44 (0)7867 141077 |
|---|---|
| angie.dempster@hhft.nhs.uk |
Scientific
Basingstoke & North Hampshire Hospital
Aldermaston Rd
Basingstoke
RG24 9NA
United Kingdom
| Phone | None provided |
|---|---|
| robin.elliot@hhft.nhs.uk |
Study information
| Study design | Interventional diagnosis imaging |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 44007_PIS_v2.0_27April2023.pdf |
| Scientific title | Prospective evaluation of nanoneedle (Nanoneedle Ankle Syndesmosis) |
| Study objectives | The current 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. |
| Ethics approval(s) |
Approved 28/04/2023, Yorkshire & Humber – Bradford Leeds REC (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle Upon Tyne, NE2 4NQ, United Kingdom; +44 (0)207 1048083; leedseast.rec@hra.nhs.uk), ref: 22/PR/1674 |
| Health condition(s) or problem(s) studied | Ankle syndesmosis injury |
| Intervention | This is a prospective study and will evaluate 20 patients with acute syndesmosis injuries requiring arthroscopic assessment and syndesmosis fixation. Suitable patients will be identified by the 3 investigator surgeons. The evaluation will be conducted in the theatre setting, in patients under general or spinal anaesthesia. Nanoneedle will be used at the start of the procedure to determine: 1. If a standard review of anatomical structures can be undertaken 2. If the injury pattern and instability can be diagnosed Nanoneedle findings will be correlated with preoperative MRI findings and findings on standard arthroscopy (4mm scope) at the time of surgery. An agreed proforma with anonymised data will be filled out for each study patient and will be sent to the Hampshire Hospitals Orthopaedic Research Team. |
| Intervention type | Other |
| Primary outcome measure | Syndesmosis instability measured using NanoNeedle at the point of use |
| Secondary outcome measures | 1. Ease-of-use of NanoNeedle compared with ankle arthroscopy measured using data recorded on a proforma at the point of use 2. Field-of-view of NanoNeedle compared with ankle arthroscopy measured using data recorded on a proforma at the point of use |
| Overall study start date | 16/06/2022 |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 20; UK Sample Size: 20 |
| Key inclusion criteria | 1. Adults aged over 18 years old 2. Acute ankle syndesmosis injury with clinical or MRI evidence of instability 3. Time of injury to surgery < 6 weeks 4. Injury patterns including posterior malleolus fractures and Maisonneuve (proximal fibula fracture) injuries) 5. Pre-operative imaging with MRI scan +/- plain radiograph |
| Key exclusion criteria | 1. Under 18 years of age 2. Ankle fracture requiring distal fibula fixation 3. No preoperative MRI scan 4. Injuries greater than 6 weeks old at the time of surgery |
| Date of first enrolment | 14/07/2023 |
| Date of final enrolment | 13/07/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Basingstoke
RG24 9NA
United Kingdom
Sponsor information
Hospital/treatment centre
Basingstoke and North Hampshire Hospital
Aldermaston Road
Basingstoke
RG24 9NA
England
United Kingdom
| Phone | +44 (0)1962824127 |
|---|---|
| siobhan.laws@hhft.nhs.uk | |
| Website | https://www.hampshirehospitals.nhs.uk |
"ROR" |
https://ror.org/04shzs249 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Arthrex Medizinische Instrumente GmbH
- Location
- Germany
Results and Publications
| Intention to publish date | 13/07/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The results will be submitted for presentation at national and international peer-attended conferences. The final manuscript will be submitted for publication in a peer-reviewed Orthopaedic journal. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2.0 | 27/04/2023 | 08/09/2023 | No | Yes |
Additional files
Editorial Notes
18/08/2025: The completion date was changed from 20/07/2024 to 31/12/2025.
26/07/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
