Syndesmotic InjuriesSynfixNCT05662449
A Cohort Study of Bioabsorbable Screws for Syndesmosis Fixation Fixation in Ankle Fracture
An observational study of Syndesmotic Injuries and Ankle Fractures, run by NHS Grampian at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Syndesmotic Injuries, Ankle Fractures, Ankle Injuries and Disorders
- What is being tested?
- Syndesmosis fixation using Activascrew
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2021to 3 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Meets above criteria with appropriate ankle fracture
Who may be able to join
- • 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cohort Study of Bioabsorbable Screws for Syndesmosis Fixation in Ankle Fracture
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.
Read the detailed description
Surgical Technique The operation requires the patient positioned supine with a sandbag beneath the ipsilateral buttock to internally rotate the leg to permit the ankle and foot to sit in neutral. Appropriate antibiotics as per local guidelines should be administered prior to insufflation of a tourniquet. Fluoroscopy is required throughout the procedure and should be positioned on the contralateral side to the injured limb to improve the access for the surgical team.
Depending on the injury type the fibula may or may not require fixation (maissoneuve or weber B/C type injury). This will be performed if necessary via a direct lateral approach to the fibula, and fixation as per surgeon preference appropriate for the fracture configuration. Typically a lag screw and one-third tubular neutralisation plate is used. Plates should be applied to the posterolateral surface of the fibula to permit passage of the syndesmosis screw through the plate and for increased mechanical stability. Following this the syndesmosis will be reduced with the foot plantigrade using large pointed reduction forceps with or without a K-wire. Medial malleolar fixation, if required, is performed after fibula fixation.
Bio-absorbable screw fixation A single 4.5 mm fully threaded ActivascrewTM (2094913CE01) is placed through four cortices if the fibula fracture is being fixed, through the plate if feasible. Two are used in the case of high fibula or maissoneuve injuries. These will all be through four cortices. A countersink may be used. The screws should be placed parallel to the tibial plafond, 2-4cm proximal to the tibio-talar joint and 30° from posterior to anterior. In the case of fibula fixation this should be though the plate if feasible. The reduction of the syndesmosis and appropriate placement of the positioning screw(s) should be checked intra-operatively with fluoroscopy. The syndesmosis is reduced, using reduction forceps. A hole is drilled with the 3.5mm drill, then tapped with the 4.5mm tap and measured. The ActivascrewTM holder and screwdriver are used to pick up and insert the desired screw. Once the screw is in position the insertion adapter is removed and discarded.
Standardised rehabilitation protocol Post operatively the patient remains non weight-bearing in a Plaster for a total of 6 weeks with a cast change, wound check and removal of sutures at 2 weeks. Following this the patient would then remain partial weight bearing in a protective boot for a further 6 weeks. The patients should be prescribed 6 weeks of Low Molecular Weight Heparin for venous thromboembolic prophylaxis as per local protocol.
Sample size considerations A total number of 40 patients should be sufficient to assess the outcome of fixation using this device.
Patients selection and enrolment Patients will be thoroughly screened to assess their suitability for the study and must fit the inclusion and exclusion criteria.
- Being tested
- Syndesmosis fixation using Activascrew
- Medical subject headings
- Ankle Injuries, Ankle Fractures, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Syndesmosis fixation using ActivascrewDevice
as described prior
| Study group | Role | What they receive |
|---|---|---|
| Ankle fracture with syndesmosis injury | Syndesmosis fixation using bioabsorbable screw Receives: Device: Syndesmosis fixation using Activascrew |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change in reduction between 2 weeks and 1 year post operatively
Secondary outcomes (9)
Surgical Duration
Tourniquet time (minutes) to represent this
Measured: Intraoperative
X- Ray (XR) Radiation exposure time and total dose
Image intensifier screening total time(seconds) and dose(cGycm2)
Measured: Intraoperative
Olerud-Molander Ankle Score (OMAS)
(Olerud-Molander Ankle Scores). Verified and reproducible patient reported scale for ankle function and symptoms. Range 0-100. High score is better.
Measured: 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)
EQ-5D-3L (European Quality of Life 5 Dimensions 3 Level Version). Validated patient health questionnaire. Score range 5-15. Lower score is better.
Measured: 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
Validated patient health questionnaire. Score range 0-100. High score is better.
Measured: 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.
American Academy Orthopaedic Surgeons Foot and Ankle Outcomes (AAOSFA)
Verified and reproducible patient reported scale for Pain, Function, Shoe wear and Alignment (numerical scoring system). Range 0-100. High score is better.
Measured: 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.
Complications
Details of any recorded minor and major complications
Measured: Up to 12 months
X-Rays (XR)
Mortise and lateral XR to assess alignment if satisfactory
Measured: 2 weeks, 6 weeks, 3 months, 6 months and 1 year post operatively.
Weight bearing tests
Assessment if can weight bearing. Stand on two sets of scales, one foot on each scale. Timed over 1 minute and assess how much weight (kg) is on each scale at 15 second intervals.
Measured: 3 months, 6 months and 1 year post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start1 Apr 2021
- Primary completion31 Dec 2025
- Study completion3 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Syndesmotic InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Grampian
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Alan Johnstone, MBChB FRCS, Principal investigator, NHS Grampian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662449
- Sponsor's protocol ID
- 209339
- Acronym
- Synfix
- Status last verified
- Dec 2022
- First submitted
- 8 Mar 2021
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23318616
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study of Bioabsorbable Screws for Syndesmosis Fixation in Ankle Fracture
- ClinicalTrials.gov ID
- NCT05662449
- Acronym / sponsor ID
- Synfix / 209339
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- NHS GrampianOther government
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 3 Feb 2026 (actual)
- First posted
- 22 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Surgical Technique The operation requires the patient positioned supine with a sandbag beneath the ipsilateral buttock to internally rotate the leg to permit the ankle and foot to sit in neutral. Appropriate antibiotics as per local guidelines should be administered prior to insufflation of a tourniquet. Fluoroscopy is required throughout the procedure and should be positioned on the contralateral side to the injured limb to improve the access for the surgical team.
Depending on the injury type the fibula may or may not require fixation (maissoneuve or weber B/C type injury). This will be performed if necessary via a direct lateral approach to the fibula, and fixation as per surgeon preference appropriate for the fracture configuration. Typically a lag screw and one-third tubular neutralisation plate is used. Plates should be applied to the posterolateral surface of the fibula to permit passage of the syndesmosis screw through the plate and for increased mechanical stability. Following this the syndesmosis will be reduced with the foot plantigrade using large pointed reduction forceps with or without a K-wire. Medial malleolar fixation, if required, is performed after fibula fixation.
Bio-absorbable screw fixation A single 4.5 mm fully threaded ActivascrewTM (2094913CE01) is placed through four cortices if the fibula fracture is being fixed, through the plate if feasible. Two are used in the case of high fibula or maissoneuve injuries. These will all be through four cortices. A countersink may be used. The screws should be placed parallel to the tibial plafond, 2-4cm proximal to the tibio-talar joint and 30° from posterior to anterior. In the case of fibula fixation this should be though the plate if feasible. The reduction of the syndesmosis and appropriate placement of the positioning screw(s) should be checked intra-operatively with fluoroscopy. The syndesmosis is reduced, using reduction forceps. A hole is drilled with the 3.5mm drill, then tapped with the 4.5mm tap and measured. The ActivascrewTM holder and screwdriver are used to pick up and insert the desired screw. Once the screw is in position the insertion adapter is removed and discarded.
Standardised rehabilitation protocol Post operatively the patient remains non weight-bearing in a Plaster for a total of 6 weeks with a cast change, wound check and removal of sutures at 2 weeks. Following this the patient would then remain partial weight bearing in a protective boot for a further 6 weeks. The patients should be prescribed 6 weeks of Low Molecular Weight Heparin for venous thromboembolic prophylaxis as per local protocol.
Sample size considerations A total number of 40 patients should be sufficient to assess the outcome of fixation using this device.
Patients selection and enrolment Patients will be thoroughly screened to assess their suitability for the study and must fit the inclusion and exclusion criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ankle fracture with syndesmosis injury | – | Device: Syndesmosis fixation using ActivascrewSyndesmosis fixation using bioabsorbable screw |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Meets above criteria with appropriate ankle fracture
Key inclusion criteria (7 listed)
- • Patient has a Weber C fibula fracture with or without a medial malleolus fracture and evidence of radiological syndesmotic widening on intra-operative stressing
Key exclusion criteria (8 listed)
- • Immobility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Syndesmosis fixation using Activascrewas described prior | Device | Ankle fracture with syndesmosis injury |
Primary outcome
Computerised Tomography (CT) scan syndesmosis
Time frame: Change in reduction between 2 weeks and 1 year post operatively
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.
9 secondary outcomes
Surgical Duration
Time frame: Intraoperative
X- Ray (XR) Radiation exposure time and total dose
Time frame: Intraoperative
Olerud-Molander Ankle Score (OMAS)
Time frame: 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)
Time frame: 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
Time frame: 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.
American Academy Orthopaedic Surgeons Foot and Ankle Outcomes (AAOSFA)
Time frame: 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.
Complications
Time frame: Up to 12 months
X-Rays (XR)
Time frame: 2 weeks, 6 weeks, 3 months, 6 months and 1 year post operatively.
Weight bearing tests
Time frame: 3 months, 6 months and 1 year post operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Background: PubMed 23318616Phisitkul 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Johnstone, MBChB FRCS principal investigator
NHS Grampian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Syndesmotic Injuries and Ankle Fractures, run by NHS Grampian at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Computerised Tomography (CT) scan syndesmosis (time frame: Change in reduction between 2 weeks and 1 year post operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05662449, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.