MedTrace Logo

A Cohort Study of Bioabsorbable Screws for Syndesmosis Fixation Fixation in Ankle Fracture

NCT05662449 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2022-12-22

No results posted yet for this study

Summary

The investigators aim to evaluate the fixation of the ankle syndesmosis in appropriate ankle fractures with bioabsorbable screws.

Ankle fractures are common, and a proportion of them involve both fracture of the bone and also disruption of the syndesmosis, a strong ligamentous complex connecting the distal fibula and tibia. If left without fixation this causes a high incidence of pain and early arthritis. The most common technique for fixation of this syndesmosis involves the use of the same type of metal screws used to fix the fractured bones. As the syndesmosis permits small degrees of movement in normal subjects, fixation of this with metal usually leads to screw breakage and, or pain. It is common practice to remove these screws after a period of time once the syndesmosis has healed in the correct position.

Bioabsorbable screws have the advantage of allowing small increments of movement, and also resorb naturally therefore do not have to be removed with a second surgical procedure. They are used in other centres worldwide, and the investigators therefore seek to evaluate syndesmosis fixation with them in their unit. The investigators would aim to recruit patients who have a syndesmotic injury requiring fixation, and who can consent to participating. They would undergo an identical surgical procedure to the standard current practice, apart from using a bioabsorbable screw in exchange for the metallic screw for syndesmosis fixation. All other components would remain unchanged, as would post operative protocol and management. To evaluate the fixation the investigators would use a limited CT scan (equivalent of about 3 months background radiation) after the time of fixation and at one year. This will help to assess the maintenance of reduction of the syndesmosis with time. The investigators would also assess patient reported outcome measures and pain scores, length of procedure and intraoperative radiation levels, weight bearing distribution tests, as well as any complication that may arise.

Conditions

  • Syndesmotic Injuries
  • Ankle Fractures
  • Ankle Injuries and Disorders

Interventions

DEVICE

Syndesmosis fixation using Activascrew

as described prior

Sponsors & Collaborators

  • NHS Grampian

    lead OTHER_GOV

Principal Investigators

  • Alan Johnstone, MBChB FRCS · NHS Grampian

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2024-12-31
Completion
2025-07-01

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05662449 on ClinicalTrials.gov