Ankle FracturesNCT02199249
Open Reduction Syndesmosis Tightrope Versus Screw Fixation
A study testing Open reduction Tightrope fixation and open reduction screw fixation in people with Ankle Fractures, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Tibia-fibular syndesmosis injury occurs in a significant proportion of ankle injuries and is assumed to disrupt the syndesmotic ligaments. The goal of operative treatment is to reduce the ankle mortise to restore normal joint kinematics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Fractures
- What is being tested?
- Open reduction Tightrope fixation and open reduction screw fixation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2015to Sep 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 18yrs with a diagnosis of a closed Weber C ankle (OTA 44.C1, 44.C2, 44.C3) fracture.
- Randomization and treatment of syndesmosis injury within 14 days of the date of injury.
- Demonstrates lateral subluxation of talus on x-ray or stress views. Talar shift > 1mm or medial clear space widening ≥ 5mm (unstable)
- No history of previous severe ankle injury, pathologic fracture, ligamentous laxity, no prior diagnosis or current treatment of osteoporosis or metabolic bone disease.
- No concurrent injury that is deemed by the treating surgeon to delay or alter the rehabilitation protocol for the ankle injury.
- No neuromuscular or sensory deficiency.
- Able to understand and complete assessments
- Provision of Informed Consent
Who cannot join
- Age < 18 years
- Open fracture or pathological fracture.
- Talar shift < 1mm or medial clear space widening < 5mm (stable)
- Prior diagnosis or current treatment for osteoporosis or metabolic bone disease.
- Concurrent injury that is deemed by the treating surgeon to delay or alter the rehabilitation protocol for the ankle injury.
- Prior diagnosis or treatment for neuromuscular disease or sensory deficiency (i.e. diabetic neuropathy).
- Likely problems, in the judgment of the investigator, with maintaining follow-up (i.e. patients with no fixed address, patients incapable of providing informed consent, prisoners etc.).
- Patients who are currently pregnant or planning to become pregnant during the study duration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Multi Center Study to Compare Open Reduction, TightRope Fixation (OT) Versus Open Reduction Screw Fixation (OS) of the Tibia - Fibular Syndesmosis.
Tibia-fibular syndesmosis injury occurs in a significant proportion of ankle injuries and is assumed to disrupt the syndesmotic ligaments.
The goal of operative treatment is to reduce the ankle mortise to restore normal joint kinematics. Syndesmosis repair can be performed using either open or closed reduction, combined with fixation between the distal tibia and fibula. Closed fixation has demonstrated high rates of non anatomic reductions greater than 40%; therefore, open reduction will be performed in this study. Screw fixation is stable but concerns exist regarding potential excess rigidity.
Read more
Recently, flexible fixation techniques combined with anatomic reduction have demonstrated improvements in functional outcomes and reduction quality. Both open reduction and flexible TightRope fixation have considerable support in the literature in cohort studies but have not been compared to open screw fixation in a randomized controlled trial.
In this multi centre randomized study, radiographic, economic and functional outcomes are compared between [open reduction, flexible Tightrope syndesmosis fixation (OT)] and [open reduction screw fixation (OS)] of the syndesmosis.
Read the detailed description
Tibia-fibular syndesmosis injury occurs in a significant proportion of ankle injuries and is assumed to disrupt the syndesmotic ligaments. The goal of operative treatment is to reduce the ankle mortise to restore normal joint kinematics. Syndesmosis repair can be performed using either open or closed reduction, combined with fixation between the distal tibia and fibula. Closed fixation has demonstrated high rates of non anatomic reductions greater than 40%; therefore, open reduction will be performed in this study. Screw fixation is stable but concerns exist regarding potential excess rigidity.
Recently, flexible fixation techniques combined with anatomic reduction have demonstrated improvements in functional outcomes and reduction quality. Both open reduction and flexible TightRope fixation have considerable support in the literature in cohort studies but have not been compared to open screw fixation in a randomized controlled trial.
This study is a multi centre randomized controlled trial comparing clinical, economic and functional outcomes between open reduction, flexible Tightrope syndesmosis fixation (OT) to open reduction rigid screw fixation (OS) for syndesmotic injuries in high ankle fractures, involving the fibula 1 cm above the level of the syndesmosis (Weber C (OTA 44.C1, 44.C2, 44C3)).
We anticipate recruiting 72 patients (36 in each arm) from up to 20 clinical sites across North America. Post operative follow up will occur at 2 and 6 weeks, 3, 6, and 12 months. At each follow up, radiographic and functional outcomes will be assessed as well as documentation of costs associated with treatment and rehabilitation.
The research questions that this study will answer include the following:
- Does open reduction and repair with TightRope syndesmosis fixation (OT) provide better reduction compared to open reduction and syndesmosis screw fixation (OS)?
- Which surgical technique provides better functional outcomes?
- Are complications and costs associated with repair comparable between surgical techniques?
The null hypothesis is that there will be no difference between the treatment groups in terms of reduction and functional testing.
The scientific aims of this study are to compare:
- anatomic (open) reduction between the two groups using CT scan and plain radiographs.
- post-operative pain and functional performance in each group.
- rates of complications and costs for each method of fixation.
- Conditions
- Ankle Fractures
- Being tested
- Open reduction Tightrope fixation, open reduction screw fixation
- Keywords
- open anatomic reduction, syndesmosis screw fixation, syndesmosis Tightrope fixation
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open reduction Tightrope fixationDevice
Also called Athrex tightrope
Device: Following fixation of Weber C fibular fracture according to AO standards, the syndesmosis will be stabilized by open reduction followed by use of a single Tightrope (Arthrex-Knotless) device. Open Reduction Tightrope fixation (OT)
open reduction screw fixationDevice
Also called syndesmosis screw fixation
Device: Following fixation of Weber C fibular fracture according to AO standards, the syndesmosis will be stabilized by open reduction followed by use of two or more syndesmosis screws. Open Reduction screw fixation (OS)
| Study group | Role | What they receive |
|---|---|---|
| Open Reduction Tightrope fixation (OT) | Active comparator | Device: Following fixation of Weber C fibular fracture according to AO standards, the syndesmosis will be stabilized by open reduction followed by use of a single Tightrope (Arthrex-Knotless) device. Open Reduction Tightrope fixation (OT) Receives: Device: Open reduction Tightrope fixation |
| Open Reduction screw fixation (OS) | Active comparator | Device: Following fixation of Weber C fibular fracture according to AO standards, the syndesmosis will be stabilized by open reduction followed by use of two or more syndesmosis screws. Open Reduction screw fixation (OS) Receives: Device: open reduction screw fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
anatomic reduction between the two groups using CT scan and plain radiographs.
anatomic reduction between the two groups using CT scan and plain radiographs
Measured: 3 months
Secondary outcomes (2)
post-operative pain
evaluated by means of patient completed visual analogue scale and questionnaires
Measured: 6 weeks, 3, 6, 12 months
functional performance
patients will complete validated self administered functional outcome, pain and quality of life questionnaires at the time of study enrolment and at 6 weeks, 3, 6 and 12 months following enrolment. Questionnaires will include a generic health status measurement instrument (EQ-5D) and a disease specific outcome measure (Foot and Ankle Disability Index (FADI)). The EQ5D is widely used to describe the extent to which patients are having a problem in each of 5 dimensions of health (mobility, ability to self care, usual activities, pain, and anxiety/depression). The FADI is designed to assess functional limitations related to foot and ankle conditions. It captures activities of daily living and more difficult tasks essential to sport activity (FADI Sport).
In addition, the AAOS Hindfoot Score will be completed by the surgeon. This score assesses pain, function, alignment, stability and motion. Patients will be asked if they have returned to work with modified duties etc.
Measured: 6 weeks, 3,6 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study startApr 2015
- Primary completionSep 2017
- Study completionSep 2017
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 Ankle FracturesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopaedic Trauma Association
- Responsible party
- Principal investigator, David Sanders, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- David Sanders, MD, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02199249
- Sponsor's protocol ID
- 105500
- Status last verified
- Feb 2018
- First submitted
- 16 Jul 2014
- Last updated
- 8 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Wong MT, Wiens C, LaMothe J, Edwards WB, Schneider PS. In Vivo Syndesmotic Motion After Rigid and Flexible Fixation Using 4-Dimensional Computerized Tomography. J Orthop Trauma. 2022 May 1;36(5):257-264. doi: 10.1097/BOT.0000000000002267.
PubMed 35594514
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Multi Center Study to Compare Open Reduction, TightRope Fixation (OT) Versus Open Reduction Screw Fixation (OS) of the Tibia - Fibular Syndesmosis.
- ClinicalTrials.gov ID
- NCT02199249
- Acronym / sponsor ID
- 105500
- Conditions
- Ankle Fractures
- Keywords
- open anatomic reduction, syndesmosis screw fixation, syndesmosis Tightrope fixation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Orthopaedic Trauma Association
- Study start
- Apr 2015 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 24 Jul 2014 (estimated)
- 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.
Tibia-fibular syndesmosis injury occurs in a significant proportion of ankle injuries and is assumed to disrupt the syndesmotic ligaments.
The goal of operative treatment is to reduce the ankle mortise to restore normal joint kinematics. Syndesmosis repair can be performed using either open or closed reduction, combined with fixation between the distal tibia and fibula. Closed fixation has demonstrated high rates of non anatomic reductions greater than 40%; therefore, open reduction will be performed in this study. Screw fixation is stable but concerns exist regarding potential excess rigidity.
Recently, flexible fixation techniques combined with anatomic reduction have demonstrated improvements in functional outcomes and reduction quality. Both open reduction and flexible TightRope fixation have considerable support in the literature in cohort studies but have not been compared to open screw fixation in a randomized controlled trial.
In this multi centre randomized study, radiographic, economic and functional outcomes are compared between [open reduction, flexible Tightrope syndesmosis fixation (OT)] and [open reduction screw fixation (OS)] of the syndesmosis.
Detailed description
Tibia-fibular syndesmosis injury occurs in a significant proportion of ankle injuries and is assumed to disrupt the syndesmotic ligaments. The goal of operative treatment is to reduce the ankle mortise to restore normal joint kinematics. Syndesmosis repair can be performed using either open or closed reduction, combined with fixation between the distal tibia and fibula. Closed fixation has demonstrated high rates of non anatomic reductions greater than 40%; therefore, open reduction will be performed in this study. Screw fixation is stable but concerns exist regarding potential excess rigidity.
Recently, flexible fixation techniques combined with anatomic reduction have demonstrated improvements in functional outcomes and reduction quality. Both open reduction and flexible TightRope fixation have considerable support in the literature in cohort studies but have not been compared to open screw fixation in a randomized controlled trial.
This study is a multi centre randomized controlled trial comparing clinical, economic and functional outcomes between open reduction, flexible Tightrope syndesmosis fixation (OT) to open reduction rigid screw fixation (OS) for syndesmotic injuries in high ankle fractures, involving the fibula 1 cm above the level of the syndesmosis (Weber C (OTA 44.C1, 44.C2, 44C3)).
We anticipate recruiting 72 patients (36 in each arm) from up to 20 clinical sites across North America. Post operative follow up will occur at 2 and 6 weeks, 3, 6, and 12 months. At each follow up, radiographic and functional outcomes will be assessed as well as documentation of costs associated with treatment and rehabilitation.
The research questions that this study will answer include the following:
- Does open reduction and repair with TightRope syndesmosis fixation (OT) provide better reduction compared to open reduction and syndesmosis screw fixation (OS)?
- Which surgical technique provides better functional outcomes?
- Are complications and costs associated with repair comparable between surgical techniques?
The null hypothesis is that there will be no difference between the treatment groups in terms of reduction and functional testing.
The scientific aims of this study are to compare:
- anatomic (open) reduction between the two groups using CT scan and plain radiographs.
- post-operative pain and functional performance in each group.
- rates of complications and costs for each method of fixation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Reduction Tightrope fixation (OT) | Active comparator | Device: Open reduction Tightrope fixationDevice: Following fixation of Weber C fibular fracture according to AO standards, the syndesmosis will be stabilized by open reduction followed by use of a single Tightrope (Arthrex-Knotless) device. Open Reduction Tightrope fixation (OT) |
| Open Reduction screw fixation (OS) | Active comparator | Device: open reduction screw fixationDevice: Following fixation of Weber C fibular fracture according to AO standards, the syndesmosis will be stabilized by open reduction followed by use of two or more syndesmosis screws. Open Reduction screw fixation (OS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female 18yrs with a diagnosis of a closed Weber C ankle (OTA 44.C1, 44.C2, 44.C3) fracture.
- Randomization and treatment of syndesmosis injury within 14 days of the date of injury.
- Demonstrates lateral subluxation of talus on x-ray or stress views. Talar shift > 1mm or medial clear space widening ≥ 5mm (unstable)
- No history of previous severe ankle injury, pathologic fracture, ligamentous laxity, no prior diagnosis or current treatment of osteoporosis or metabolic bone disease.
- No concurrent injury that is deemed by the treating surgeon to delay or alter the rehabilitation protocol for the ankle injury.
Key exclusion criteria (8 listed)
- Age < 18 years
- Open fracture or pathological fracture.
- Talar shift < 1mm or medial clear space widening < 5mm (stable)
- Prior diagnosis or current treatment for osteoporosis or metabolic bone disease.
- Concurrent injury that is deemed by the treating surgeon to delay or alter the rehabilitation protocol for the ankle injury.
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 |
|---|---|---|
| Open reduction Tightrope fixationAlso: Athrex tightropeDevice: Following fixation of Weber C fibular fracture according to AO standards, the syndesmosis will be stabilized by open reduction followed by use of a single Tightrope (Arthrex-Knotless) device. Open Reduction Tightrope fixation (OT) | Device | Open Reduction Tightrope fixation (OT) |
| open reduction screw fixationAlso: syndesmosis screw fixationDevice: Following fixation of Weber C fibular fracture according to AO standards, the syndesmosis will be stabilized by open reduction followed by use of two or more syndesmosis screws. Open Reduction screw fixation (OS) | Device | Open Reduction screw fixation (OS) |
Primary outcome
anatomic reduction between the two groups using CT scan and plain radiographs.
Time frame: 3 months
anatomic reduction between the two groups using CT scan and plain radiographs
2 secondary outcomes
post-operative pain
Time frame: 6 weeks, 3, 6, 12 months
functional performance
Time frame: 6 weeks, 3,6 12 months
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 Feb 2018.
- Derived from this study: PubMed 35594514Wong MT, Wiens C, LaMothe J, Edwards WB, Schneider PS. In Vivo Syndesmotic Motion After Rigid and Flexible Fixation Using 4-Dimensional Computerized Tomography. J Orthop Trauma. 2022 May 1;36(5):257-264. doi: 10.1097/BOT.0000000000002267.
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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.
David Sanders, MD principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open reduction Tightrope fixation and open reduction screw fixation in people with Ankle Fractures, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 8 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 Feb 2018. 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 Canada. 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?
anatomic reduction between the two groups using CT scan and plain radiographs. (time frame: 3 months). 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 NCT02199249, 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 Feb 2018.