Ankle FracturesS16NCT02930486
Ziptight or Tricortical Screw Fixation of Acute Tibiofibular Syndesmotic Injury
A study testing ZipTight suture endobutton and Tricortical 3.5 mm syndesmotic screw in people with Ankle Fractures, run by Vestre Viken Hospital Trust at 1 site in Norway.
Trial summary
Treatment of syndesmotic injury with Weber C fracture. A randomized study comparing ZipTight suture endobutton and one tricortical 3,5 mm syndesmotic screw. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ankle Fractures
- What is being tested?
- ZipTight suture endobutton and Tricortical 3.5 mm syndesmotic screw
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2016to Oct 2019
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 70 years
- Acute syndesmotic injury with Weber type C fracture
Who cannot join
- Prior injury og the same ankle
- Severe injury of the same leg affecting rehabilitation
- Symptomatic osteoarthritis of same ankle
- open injury
- Decubital injury affecting surgical site
- Dementia or unable to sign informed consent
- neuropatic conditions affecting same leg
Trial locations and contacts
1 site in 1 country.
About this study
Treatment of syndesmotic injury with Weber C fracture. A randomized study comparing ZipTight suture endobutton and one tricortical 3,5 mm syndesmotic screw.
Read the detailed description
Syndesmotic injuries are common and often associated with unstable ankle fractures. The most common treatment is with a syndesmotic screw through the fibula and tibia which is later removed, usually after 10-12 weeks. The ZipTight suture endobutton (Biomet) is used for the same indication. It does not need removal and thus avoids subsequent surgery. This trial will compare these two methods and see if they are equal.
patients 18-70 years presenting to one of the three hospitals with and acute syndesmotic injury are eligible for inclusion. 120 patients are randomized to two treatment groups. One group will be treated with a ZipTight suture endobutton fixation and the other receives a tricortical screw fixation. Neither suture endobutton or screw is routinely removed. Follow up intervals are at 6 weeks, 6, 12 and 24 months with clinical and-points. Standardized CT scans are taken postoperatively and at 12 and 24 months.
- Conditions
- Ankle Fractures
- Being tested
- ZipTight suture endobutton, Tricortical 3.5 mm syndesmotic screw
- Keywords
- Syndesmosis, Injury, Ankle, Fracture, Weber C
- Medical subject headings
- Ankle Fractures, Wounds and Injuries, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZipTight suture endobuttonDevice
Zimmer Biomet ZipTight suture endobutton
Tricortical 3.5 mm syndesmotic screwDevice
Depuy Synthes 3.5 mm screw
| Study group | Role | What they receive |
|---|---|---|
| ZipTight | Active comparator | ZipTight suture endobutton Receives: Device: ZipTight suture endobutton |
| Syndesmotic screw | Active comparator | Tricortical 3.5 mm syndesmotic screw Receives: Device: Tricortical 3.5 mm syndesmotic screw |
What is being measured
The primary outcome is the main question the study is designed to answer.
OTA Score (Modified American Orthopaedic Foot and Ankle Society ankle hind foot score)
Modified American Orthopaedic Foot and Ankle Society ankle hind foot score (0-100)
Measured: 24 months
Secondary outcomes (5)
Manchester-Oxford Foot questionnaire (MOxFQ)
Measured: 24 months
Dorsiflexion angle
according to Lindsjø
Measured: 24 months
Health-related quality of life (EQ-5D)
Measured: 24 months
CT measurements of syndesmotic distance
Measured: 24 months
VAS
visual analogue scale
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study startJan 2016
- Primary completion30 Sep 2017
- Study completionOct 2019
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vestre Viken Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, Ostfold Hospital Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02930486
- Sponsor's protocol ID
- Syndesmose2016
- Acronym
- S16
- Status last verified
- Nov 2019
- First submitted
- 18 Apr 2016
- Last updated
- 29 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Raeder BW, Stake IK, Madsen JE, Frihagen F, Jacobsen SB, Andersen MR, Figved W. Randomized trial comparing suture button with single 3.5 mm syndesmotic screw for ankle syndesmosis injury: similar results at 2 years. Acta Orthop. 2020 Dec;91(6):770-775. doi: 10.1080/17453674.2020.1818175. Epub 2020 Sep 10.
PubMed 32907456
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ziptight or Tricortical Screw Fixation of Acute Tibiofibular Syndesmotic Injury
- ClinicalTrials.gov ID
- NCT02930486
- Acronym / sponsor ID
- S16 / Syndesmose2016
- Conditions
- Ankle Fractures
- Keywords
- Syndesmosis, Injury, Ankle, Fracture, Weber C
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Vestre Viken Hospital TrustUniversity, hospital or other
- Collaborators
- Oslo University Hospital, Ostfold Hospital Trust
- Study start
- Jan 2016
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 12 Oct 2016 (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.
Treatment of syndesmotic injury with Weber C fracture. A randomized study comparing ZipTight suture endobutton and one tricortical 3,5 mm syndesmotic screw.
Detailed description
Syndesmotic injuries are common and often associated with unstable ankle fractures. The most common treatment is with a syndesmotic screw through the fibula and tibia which is later removed, usually after 10-12 weeks. The ZipTight suture endobutton (Biomet) is used for the same indication. It does not need removal and thus avoids subsequent surgery. This trial will compare these two methods and see if they are equal.
patients 18-70 years presenting to one of the three hospitals with and acute syndesmotic injury are eligible for inclusion. 120 patients are randomized to two treatment groups. One group will be treated with a ZipTight suture endobutton fixation and the other receives a tricortical screw fixation. Neither suture endobutton or screw is routinely removed. Follow up intervals are at 6 weeks, 6, 12 and 24 months with clinical and-points. Standardized CT scans are taken postoperatively and at 12 and 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZipTight | Active comparator | Device: ZipTight suture endobuttonZipTight suture endobutton |
| Syndesmotic screw | Active comparator | Device: Tricortical 3.5 mm syndesmotic screwTricortical 3.5 mm syndesmotic screw |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 to 70 years
- Acute syndesmotic injury with Weber type C fracture
Key exclusion criteria (7 listed)
- Prior injury og the same ankle
- Severe injury of the same leg affecting rehabilitation
- Symptomatic osteoarthritis of same ankle
- open injury
- Decubital injury affecting surgical site
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 |
|---|---|---|
| ZipTight suture endobuttonZimmer Biomet ZipTight suture endobutton | Device | ZipTight |
| Tricortical 3.5 mm syndesmotic screwDepuy Synthes 3.5 mm screw | Device | Syndesmotic screw |
Primary outcome
OTA Score (Modified American Orthopaedic Foot and Ankle Society ankle hind foot score)
Time frame: 24 months
Modified American Orthopaedic Foot and Ankle Society ankle hind foot score (0-100)
5 secondary outcomes
Manchester-Oxford Foot questionnaire (MOxFQ)
Time frame: 24 months
Dorsiflexion angle
Time frame: 24 months
Health-related quality of life (EQ-5D)
Time frame: 24 months
CT measurements of syndesmotic distance
Time frame: 24 months
VAS
Time frame: 24 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 29 Nov 2019.
- Derived from this study: PubMed 32907456Raeder BW, Stake IK, Madsen JE, Frihagen F, Jacobsen SB, Andersen MR, Figved W. Randomized trial comparing suture button with single 3.5 mm syndesmotic screw for ankle syndesmosis injury: similar results at 2 years. Acta Orthop. 2020 Dec;91(6):770-775. doi: 10.1080/17453674.2020.1818175. Epub 2020 Sep 10.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ZipTight suture endobutton and Tricortical 3.5 mm syndesmotic screw in people with Ankle Fractures, run by Vestre Viken Hospital Trust at 1 site in Norway.
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 2 inclusion and 7 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 29 Nov 2019. 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 Norway. 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?
OTA Score (Modified American Orthopaedic Foot and Ankle Society ankle hind foot score) (time frame: 24 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 NCT02930486, 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 29 Nov 2019.