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NCT05662449
A Cohort Study of Bioabsorbable Screws for Syndesmosis Fixation Fixation in Ankle Fracture
Conditions: Syndesmotic Injuries, Ankle Fractures, Ankle Injuries and Disorders
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: 1
Enrollment: 40
Sponsor: NHS Grampian
Location: United Kingdom
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.
Eligibility 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 stressingPatient has a Weber B fracture with evidence of syndesmosis widening radiologically on stressing intra-operativelyPatient has a maissoneuve type injury with evidence of syndesmotic diastasisPatient mobilises independently, with or without aids.Patient has given formal consent to be involved in the trial and has completed the study consent formPatient is likely to comply with study requirementsPatient is over the age of 18 years and under 65 yearsExclusion Criteria:• ImmobilityPresence of a posterior malleolus fracture involving >25% of articular surfaceOpen fracturesPathological fracturesOther fractures involving the same lower extremityPatient unwilling to give informed consent to be included in the trialPatient has other injuries that would influence the studyAny ankle fracture that the treating surgeon feels inappropriate to be included in the study
Source: ClinicalTrials.gov (NCT05662449). StuddyBuddy aggregates publicly available trial information.