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

NCT05662449 | Unknown DMC

• 1 other identifier: 209339
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Computerised Tomography (CT) scan syndesmosis

  All patients will undergo focused CT scanning two weeks post operatively and at one year. A customised foot holding device will enable to scan to be taken with both feet in neutral alignment (Evolution supine foot positioner, Vasocare Ltd). Assessment will be made in comparison with the contralateral side to assess reduction of the syndesmosis. Quantitive measurement of reduction will be measured using an established technique from the paper cited below in references.

  Change in reduction between 2 weeks and 1 year post operatively

Secondary Outcomes (9)

• Surgical Duration

  Intraoperative

• X- Ray (XR) Radiation exposure time and total dose

  Intraoperative

• Olerud-Molander Ankle Score (OMAS)

  Pre-operative (baseline), 3 months, 6 months and 1 year post operatively. Absolute values measured as well as change in score over time intervals noted.

• EQ5D3L (European Quality of Life 5 Dimensions 3 Level Version)

  Pre-operative (baseline), 3 months, 6 months and 1 year post operatively.Absolute values measured as well as change in score over time intervals noted.

• EQ-5D-3L VAS (European Quality of Life 5 Dimensions 3 Level Version) Health state

  Pre-operative (baseline), 3 months, 6 months and 1 year post operatively.Absolute values measured as well as change in score over time intervals noted.

Study Arms (1)

Ankle fracture with syndesmosis injury

Syndesmosis fixation using bioabsorbable screw

Device: Syndesmosis fixation using Activascrew

Interventions

Syndesmosis fixation using Activascrew DEVICE

as described prior

Ankle fracture with syndesmosis injury

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Meets above criteria with appropriate ankle fracture

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NHS Grampian: lead

Study Sites (1)

Aberdeen Royal Infirmary

Aberdeen, AB25 2ZN, United Kingdom

RECRUITING

Related Publications (1)

• Phisitkul P, Ebinger T, Goetz J, Vaseenon T, Marsh JL. Forceps reduction of the syndesmosis in rotational ankle fractures: a cadaveric study. J Bone Joint Surg Am. 2012 Dec 19;94(24):2256-61. doi: 10.2106/JBJS.K.01726.

  PMID: 23318616 BACKGROUND

MeSH Terms

Conditions

Ankle Injuries; Ankle Fractures; Disease

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Fractures, Bone; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alan Johnstone, MBChB FRCS

  NHS Grampian

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariam Sattar, MBChB(Hons)

CONTACT

00441224552310; mariam.sattar@nhs.scot

Alan Johnstone, MBChB FRCS

CONTACT

Alan.johnstone2@nhs.scot

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: December 22, 2022
• Study Start: April 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: July 1, 2025
• Last Updated: December 22, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)