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NanoNeedle evaluation study

Prospective evaluation of nanoneedle (Nanoneedle Ankle Syndesmosis)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11167914
Enrollment
20
Registered
2023-09-25
Start date
2023-07-14
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Ankle syndesmosis injury Musculoskeletal Diseases

Interventions

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 inve

Sponsors

Hampshire Hospitals NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 150 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Syndesmosis instability measured using NanoNeedle at the point of use

Secondary

MeasureTime frame
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

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026