Syndesmotic InjuriesNCT05626036
Randomized Controlled Trial Comparing Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries
A study testing Arthrex Tightrope and Synthes Fibulink in people with Syndesmotic Injuries, run by United States Naval Medical Center, San Diego at 1 site in United States.
Trial summary
Ankle fractures are a common injury with potentially significant morbidity. Syndesmosis injury occurs in 10% to 13% of ankle fractures and poses a greater risk to long-term outcomes for patients. The gold standard for syndesmosis fixation has traditionally been screw fixation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Syndesmotic Injuries
- What is being tested?
- Arthrex Tightrope and Synthes Fibulink
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2022to Dec 2024
- 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
- Ankle fracture with associated syndesmotic injury requiring surgery
- Age 18 years or older
- Ability to understand the content of the patient information/Informed consent form
Who cannot join
- Any not medically managed severe systemic disease
- Patient preference for specific implant
- Refusal of randomization
- Pregnant patients
- Prisoners
- Participation in any other pharmacologic or medicinal product study within the previous month that could influence the results of this study
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Naval Medical Center San Diego
San Diego, California, 92134
Ashley Hughey
Benjamin Wheatley
About this study
Official title: Randomized Controlled Trial Comparing Clinical Outcomes of Patients Treated Surgically With Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries
Ankle fractures are a common injury with potentially significant morbidity. Syndesmosis injury occurs in 10% to 13% of ankle fractures and poses a greater risk to long-term outcomes for patients.
The gold standard for syndesmosis fixation has traditionally been screw fixation. However, issues with screw fixation include screw breakage, screw loosening, reoperation, and malreduction. Due to growing concerns with static screw fixation, implants based on the flexible suture button design, such as the TightRope system, gained traction.
Read more
The Fibulink Syndesmosis Repair System, a relatively new design that became clinically available in 2017, has showed promising results.
To our knowledge, there is no study that directly compares outcomes with the Fibulink implant to suture button implants.
Read the detailed description
Ankle fractures are a common injury with potentially significant morbidity. Syndesmosis injury occurs in 10% to 13% of ankle fractures and poses a greater risk to long-term outcomes for patients1,2. If not recognized and adequately reduced, injuries to the syndesmosis have shown to result in instability, persistent pain, and post-traumatic arthritis3. 11% of cases are accompanied by symptomatic advanced osteoarthritis after fixation of the syndesmosis4.
The gold standard for syndesmosis fixation has traditionally been screw fixation5. However, issues with screw fixation include screw breakage, screw loosening, reoperation, and malreduction6-8. This has been speculated to be a result of the ankle syndesmosis, a dynamic construct, being inappropriately fixed with static fixation. Due to growing concerns with static screw fixation, implants based on the flexible suture button design, such as the TightRope system, gained traction. Advantages with these designs include superior outcome scores, as well as lower rates of osteoarthritis and reoperation7,9,10. However, despite achieving improved joint mechanics, these systems have their drawbacks as well, such as infection or damage to the superficial medial neurovascular bundle9.
The Fibulink Syndesmosis Repair System, a relatively new design that became clinically available in 2017, has showed promising results. It has been promoted as an implant that potentially provides both the fixation of a screw and flexibility of a suture to respect the dynamic nature of the ankle joint. Benefits of this design include eliminating damage to the medial neurovascular bundle and soft tissues, promoting physiologic motion of the ankle joint, and allowing improved tension control. In a case series with 14 patients that received the Fibulink implant, Desai found no complications with a mean follow-up of 9.5 months9. However, more long-term data is needed in order to draw any conclusions. The potential advantage of this system over suture button designs is that it incorporates the rigidity of screw fixation on top of the dynamic fixation of suture button implants. It also addresses the limitations of suture button designs, such as avoiding medial soft tissue disruption and lack of two-way tension control.
The comparison between screw fixation and suture button designs has been thoroughly investigated in the literature. To our knowledge, there is no study that directly compares outcomes with the Fibulink implant to suture button implants. It is imperative to directly compare these methods so we can definitively assess their suitability and provide patients that sustain these injuries the best method of fixation in order to improve patient outcomes.
The purpose of this study is to compare radiographic and clinical outcomes in patients who sustain an acute ankle fracture with an associated syndesmosis injury by comparing two surgical treatments currently in the practice of the study investigators. The study will compare suture button fixation versus Fibulink implant in patients with this injury.
Inadequate syndesmosis fixation has been found to result in significant morbidity to patients, including persistent pain, instability, and post-traumatic arthritis. This emphasizes the need to assess the available methods of fixation in order to minimize negative long-term consequences. Currently, standard single screw fixation remains a common choice among orthopaedic surgeons. However, there is some evidence of superior outcomes with dynamic fixation, using designs such as the suture button or the Fibulink system, in terms of functional results, residual pain, and other measures. With an enhanced understanding of patient outcomes with these methods of fixation, we will better be able to determine more effective ways to manage these injures and offer guidance for optimal management and patient satisfaction.
- Conditions
- Syndesmotic Injuries
- Being tested
- Arthrex Tightrope, Synthes Fibulink
- Keywords
- syndesmosis, clinical outcomes, ankle fracture
- Medical subject headings
- Ankle Injuries, Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthrex TightropeDevice
High-tensile strength suture syndesmosis repair
Synthes FibulinkDevice
High-tensile strength suture syndesmosis repair
| Study group | Role | What they receive |
|---|---|---|
| Arthrex Tightrope | Active comparator | Syndesmosis fixation performed with Arthrex Tightrope device. This is a high-tension suture fixation with a button based anchor system. Receives: Device: Arthrex Tightrope |
| Synthes Fibulink | Experimental | Syndesmosis fixation performed with Synthes Fibulink device. This is a high-tension suture fixation with a screw based anchor system. Receives: Device: Synthes Fibulink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) pain score
VAS pain score is rated from 0-10 with 0 being no pain and 10 being the worst pain possible.
Measured: 1 year
Foot and Ankle Disability Index
Functional score with a score of 0-104 with higher scores indicating better function.
Measured: 1 year
Olerud-Molander Ankle Score
Functional score with a score of 0-100 with higher scores indicating better function
Measured: 1 year
Secondary outcomes (1)
Number of participants with medical or surgical complications
Medical and surgical complications to include: surgical site infection, re-operation, device failure, loss of motion
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start1 Dec 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Benjamin Wheatley, United States Naval Medical Center, San Diego
- Investigators
- Benjamin Wheatley, Principal investigator, NMCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05626036
- Sponsor's protocol ID
- 21-14036
- Status last verified
- May 2024
- First submitted
- 12 Oct 2022
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Lindsjo U. Operative treatment of ankle fractures. Acta Orthop Scand Suppl. 1981;189:1-131. doi: 10.3109/ort.1981.52.suppl-189.01.
PubMed 6787831Court-Brown CM, McBirnie J, Wilson G. Adult ankle fractures--an increasing problem? Acta Orthop Scand. 1998 Feb;69(1):43-7. doi: 10.3109/17453679809002355.
PubMed 9524517Sagi HC, Shah AR, Sanders RW. The functional consequence of syndesmotic joint malreduction at a minimum 2-year follow-up. J Orthop Trauma. 2012 Jul;26(7):439-43. doi: 10.1097/BOT.0b013e31822a526a.
PubMed 22357084Ray R, Koohnejad N, Clement ND, Keenan GF. Ankle fractures with syndesmotic stabilisation are associated with a high rate of secondary osteoarthritis. Foot Ankle Surg. 2019 Apr;25(2):180-185. doi: 10.1016/j.fas.2017.10.005. Epub 2017 Oct 28.
PubMed 29409288Bava E, Charlton T, Thordarson D. Ankle fracture syndesmosis fixation and management: the current practice of orthopedic surgeons. Am J Orthop (Belle Mead NJ). 2010 May;39(5):242-6.
PubMed 20567742Gardner MJ, Demetrakopoulos D, Briggs SM, Helfet DL, Lorich DG. Malreduction of the tibiofibular syndesmosis in ankle fractures. Foot Ankle Int. 2006 Oct;27(10):788-92. doi: 10.1177/107110070602701005.
PubMed 17054878Laflamme M, Belzile EL, Bedard L, van den Bekerom MP, Glazebrook M, Pelet S. A prospective randomized multicenter trial comparing clinical outcomes of patients treated surgically with a static or dynamic implant for acute ankle syndesmosis rupture. J Orthop Trauma. 2015 May;29(5):216-23. doi: 10.1097/BOT.0000000000000245.
PubMed 25260059Naqvi GA, Cunningham P, Lynch B, Galvin R, Awan N. Fixation of ankle syndesmotic injuries: comparison of tightrope fixation and syndesmotic screw fixation for accuracy of syndesmotic reduction. Am J Sports Med. 2012 Dec;40(12):2828-35. doi: 10.1177/0363546512461480. Epub 2012 Oct 10.
PubMed 23051785Raeder BW, Figved W, Madsen JE, Frihagen F, Jacobsen SB, Andersen MR. Better outcome for suture button compared with single syndesmotic screw for syndesmosis injury: five-year results of a randomized controlled trial. Bone Joint J. 2020 Feb;102-B(2):212-219. doi: 10.1302/0301-620X.102B2.BJJ-2019-0692.R2.
PubMed 32009435
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Clinical Outcomes of Patients Treated Surgically With Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries
- ClinicalTrials.gov ID
- NCT05626036
- Acronym / sponsor ID
- 21-14036
- Conditions
- Syndesmotic Injuries
- Keywords
- syndesmosis, clinical outcomes, ankle fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 23 Nov 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.
Ankle fractures are a common injury with potentially significant morbidity. Syndesmosis injury occurs in 10% to 13% of ankle fractures and poses a greater risk to long-term outcomes for patients.
The gold standard for syndesmosis fixation has traditionally been screw fixation. However, issues with screw fixation include screw breakage, screw loosening, reoperation, and malreduction. Due to growing concerns with static screw fixation, implants based on the flexible suture button design, such as the TightRope system, gained traction.
The Fibulink Syndesmosis Repair System, a relatively new design that became clinically available in 2017, has showed promising results.
To our knowledge, there is no study that directly compares outcomes with the Fibulink implant to suture button implants.
Detailed description
Ankle fractures are a common injury with potentially significant morbidity. Syndesmosis injury occurs in 10% to 13% of ankle fractures and poses a greater risk to long-term outcomes for patients1,2. If not recognized and adequately reduced, injuries to the syndesmosis have shown to result in instability, persistent pain, and post-traumatic arthritis3. 11% of cases are accompanied by symptomatic advanced osteoarthritis after fixation of the syndesmosis4.
The gold standard for syndesmosis fixation has traditionally been screw fixation5. However, issues with screw fixation include screw breakage, screw loosening, reoperation, and malreduction6-8. This has been speculated to be a result of the ankle syndesmosis, a dynamic construct, being inappropriately fixed with static fixation. Due to growing concerns with static screw fixation, implants based on the flexible suture button design, such as the TightRope system, gained traction. Advantages with these designs include superior outcome scores, as well as lower rates of osteoarthritis and reoperation7,9,10. However, despite achieving improved joint mechanics, these systems have their drawbacks as well, such as infection or damage to the superficial medial neurovascular bundle9.
The Fibulink Syndesmosis Repair System, a relatively new design that became clinically available in 2017, has showed promising results. It has been promoted as an implant that potentially provides both the fixation of a screw and flexibility of a suture to respect the dynamic nature of the ankle joint. Benefits of this design include eliminating damage to the medial neurovascular bundle and soft tissues, promoting physiologic motion of the ankle joint, and allowing improved tension control. In a case series with 14 patients that received the Fibulink implant, Desai found no complications with a mean follow-up of 9.5 months9. However, more long-term data is needed in order to draw any conclusions. The potential advantage of this system over suture button designs is that it incorporates the rigidity of screw fixation on top of the dynamic fixation of suture button implants. It also addresses the limitations of suture button designs, such as avoiding medial soft tissue disruption and lack of two-way tension control.
The comparison between screw fixation and suture button designs has been thoroughly investigated in the literature. To our knowledge, there is no study that directly compares outcomes with the Fibulink implant to suture button implants. It is imperative to directly compare these methods so we can definitively assess their suitability and provide patients that sustain these injuries the best method of fixation in order to improve patient outcomes.
The purpose of this study is to compare radiographic and clinical outcomes in patients who sustain an acute ankle fracture with an associated syndesmosis injury by comparing two surgical treatments currently in the practice of the study investigators. The study will compare suture button fixation versus Fibulink implant in patients with this injury.
Inadequate syndesmosis fixation has been found to result in significant morbidity to patients, including persistent pain, instability, and post-traumatic arthritis. This emphasizes the need to assess the available methods of fixation in order to minimize negative long-term consequences. Currently, standard single screw fixation remains a common choice among orthopaedic surgeons. However, there is some evidence of superior outcomes with dynamic fixation, using designs such as the suture button or the Fibulink system, in terms of functional results, residual pain, and other measures. With an enhanced understanding of patient outcomes with these methods of fixation, we will better be able to determine more effective ways to manage these injures and offer guidance for optimal management and patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Arthrex Tightrope | Active comparator | Device: Arthrex TightropeSyndesmosis fixation performed with Arthrex Tightrope device. This is a high-tension suture fixation with a button based anchor system. |
| Synthes Fibulink | Experimental | Device: Synthes FibulinkSyndesmosis fixation performed with Synthes Fibulink device. This is a high-tension suture fixation with a screw based anchor system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ankle fracture with associated syndesmotic injury requiring surgery
- Age 18 years or older
- Ability to understand the content of the patient information/Informed consent form
Key exclusion criteria (6 listed)
- Any not medically managed severe systemic disease
- Patient preference for specific implant
- Refusal of randomization
- Pregnant patients
- Prisoners
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 |
|---|---|---|
| Arthrex TightropeHigh-tensile strength suture syndesmosis repair | Device | Arthrex Tightrope |
| Synthes FibulinkHigh-tensile strength suture syndesmosis repair | Device | Synthes Fibulink |
Primary outcome
Visual Analog Scale (VAS) pain score
Time frame: 1 year
VAS pain score is rated from 0-10 with 0 being no pain and 10 being the worst pain possible.
Foot and Ankle Disability Index
Time frame: 1 year
Functional score with a score of 0-104 with higher scores indicating better function.
Olerud-Molander Ankle Score
Time frame: 1 year
Functional score with a score of 0-100 with higher scores indicating better function
1 secondary outcome
Number of participants with medical or surgical complications
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Results publication: PubMed 6787831Lindsjo U. Operative treatment of ankle fractures. Acta Orthop Scand Suppl. 1981;189:1-131. doi: 10.3109/ort.1981.52.suppl-189.01.
- Results publication: PubMed 9524517Court-Brown CM, McBirnie J, Wilson G. Adult ankle fractures--an increasing problem? Acta Orthop Scand. 1998 Feb;69(1):43-7. doi: 10.3109/17453679809002355.
- Results publication: PubMed 22357084Sagi HC, Shah AR, Sanders RW. The functional consequence of syndesmotic joint malreduction at a minimum 2-year follow-up. J Orthop Trauma. 2012 Jul;26(7):439-43. doi: 10.1097/BOT.0b013e31822a526a.
- Results publication: PubMed 29409288Ray R, Koohnejad N, Clement ND, Keenan GF. Ankle fractures with syndesmotic stabilisation are associated with a high rate of secondary osteoarthritis. Foot Ankle Surg. 2019 Apr;25(2):180-185. doi: 10.1016/j.fas.2017.10.005. Epub 2017 Oct 28.
- Results publication: PubMed 20567742Bava E, Charlton T, Thordarson D. Ankle fracture syndesmosis fixation and management: the current practice of orthopedic surgeons. Am J Orthop (Belle Mead NJ). 2010 May;39(5):242-6.
- Results publication: PubMed 17054878Gardner MJ, Demetrakopoulos D, Briggs SM, Helfet DL, Lorich DG. Malreduction of the tibiofibular syndesmosis in ankle fractures. Foot Ankle Int. 2006 Oct;27(10):788-92. doi: 10.1177/107110070602701005.
- Results publication: PubMed 25260059Laflamme M, Belzile EL, Bedard L, van den Bekerom MP, Glazebrook M, Pelet S. A prospective randomized multicenter trial comparing clinical outcomes of patients treated surgically with a static or dynamic implant for acute ankle syndesmosis rupture. J Orthop Trauma. 2015 May;29(5):216-23. doi: 10.1097/BOT.0000000000000245.
- Results publication: PubMed 23051785Naqvi GA, Cunningham P, Lynch B, Galvin R, Awan N. Fixation of ankle syndesmotic injuries: comparison of tightrope fixation and syndesmotic screw fixation for accuracy of syndesmotic reduction. Am J Sports Med. 2012 Dec;40(12):2828-35. doi: 10.1177/0363546512461480. Epub 2012 Oct 10.
- Results publication: PubMed 32009435Raeder BW, Figved W, Madsen JE, Frihagen F, Jacobsen SB, Andersen MR. Better outcome for suture button compared with single syndesmotic screw for syndesmosis injury: five-year results of a randomized controlled trial. Bone Joint J. 2020 Feb;102-B(2):212-219. doi: 10.1302/0301-620X.102B2.BJJ-2019-0692.R2.
- Individual participant dataSharing planned: No
Related trials for Syndesmotic Injuries
RecruitingObservational study
Computed Tomography With Stress Maneuvers for Evaluation of Distal Tibiofibular Syndesmosis Instability (CTMETS)
Ankle Sprain
Not yet recruiting
Dynamic Fixation for Complex Ankle Fractures With Syndesmotic Diastasis.
Ankle Fractures, Syndesmotic Injury of the Ankle
Active, not recruiting
Stability of Distal Tibiofibular Syndesmosis With or Without Fixation of Posterior Fragments in Bimalleolar Fractures
Ankle Fractures, Osteoarthritis, Ankle
Not yet recruiting
Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery
Ankle Fractures, Syndesmotic Injury
Recruiting
Fibulink Syndesmosis Repair System With Early Full-Weight Bearing
Ankle Fractures, Bimalleolar Fractures
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.
Benjamin Wheatley principal investigator
NMCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthrex Tightrope and Synthes Fibulink in people with Syndesmotic Injuries, run by United States Naval Medical Center, San Diego at 1 site in United States.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 6 May 2024. 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 States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ashley Hughey (619-532-9535, ashley.e.hughey.ctr@health.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) pain score (time frame: 1 year). The study lists 3 primary outcomes in all. 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 NCT05626036, which also lists 9 linked publications.
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 6 May 2024.