Using bioabsorbable screws for ankle fracture fixation
A Cohort Study of Bioabsorbable Screws for Syndesmosis Fixation in Ankle Fracture
This study tests whether using bioabsorbable screws instead of metal ones can help people with certain ankle fractures heal better and avoid extra surgeries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | NHS Grampian Government |
| Drugs / interventions | radiation |
| Locations | 1 site (Aberdeen) |
| Trial ID | NCT05662449 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of bioabsorbable screws for fixing the syndesmosis in patients with specific types of ankle fractures. The approach aims to provide a solution to the common issue of pain and complications associated with traditional metal screws, which often require removal after healing. The surgical procedure involves careful positioning and the use of fluoroscopy to ensure accurate placement of the screws. By utilizing bioabsorbable materials, the study seeks to improve patient outcomes and reduce the need for additional surgeries.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with specific types of fibula fractures and evidence of syndesmotic widening.
Not a fit: Patients with immobility, open fractures, or other significant injuries to the lower extremity may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to less pain and fewer complications for patients with ankle fractures requiring syndesmosis fixation.
How similar studies have performed: While the use of bioabsorbable screws is a relatively novel approach, similar studies have shown promising results in reducing complications associated with traditional fixation methods.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • Patient has a Weber C fibula fracture with or without a medial malleolus fracture and evidence of radiological syndesmotic widening on intra-operative stressing * Patient has a Weber B fracture with evidence of syndesmosis widening radiologically on stressing intra-operatively * Patient has a maissoneuve type injury with evidence of syndesmotic diastasis * Patient mobilises independently, with or without aids. * Patient has given formal consent to be involved in the trial and has completed the study consent form * Patient is likely to comply with study requirements * Patient is over the age of 18 years and under 65 years Exclusion Criteria: * • Immobility * Presence of a posterior malleolus fracture involving \>25% of articular surface * Open fractures * Pathological fractures * Other fractures involving the same lower extremity * Patient unwilling to give informed consent to be included in the trial * Patient has other injuries that would influence the study * Any ankle fracture that the treating surgeon feels inappropriate to be included in the study
Where this trial is running
Aberdeen
- Aberdeen Royal Infirmary — Aberdeen, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Alan Johnstone, MBChB FRCS — NHS Grampian
- Study coordinator: Mariam Sattar, MBChB(Hons)
- Email: mariam.sattar@nhs.scot
- Phone: 00441224552310
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.