Syndesmotic Injury of the AnkleTIGHTROPE-SSNCT01275924
Tightrope or Screw Fixation of Acute Tibiofibular Syndesmotic Injury
A study testing Tightrope Syndesmosis Repair Kit and Syndesmotic screw in people with Syndesmotic Injury of the Ankle, run by Sykehuset Asker og Baerum at 2 sites in Norway.
Trial summary
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 Tightrope Syndesmosis Repair Kit (Arthrex; Naples, Florida). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Syndesmotic Injury of the Ankle
- What is being tested?
- Tightrope Syndesmosis Repair Kit and Syndesmotic screw
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 2 sitesNorway
- Study dates
- Jan 2011to Apr 2018
- 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 or without Weber type C fracture
Who cannot join
- Prior injury of the same ankle
- Severe injury of same leg affecting rehabilitation
- Symptomatic osteoarthritis of same ankle
- Open injury
- Decubital injury affecting surgical site
- Dementia or unable to sign informed consent
- Neuropathic conditions affecting same leg
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Oslo University Hospital
Oslo, 0407
Baerum Hospital, Vestre Viken
Rud, 1351
About this study
Official title: Tightrope or Screw Fixation of Acute Tibiofibular Syndesmotic Injury. Randomised Controlled Trial.
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 Tightrope Syndesmosis Repair Kit (Arthrex; Naples, Florida). is used for the same indication, it consists of a heavy suture placed across the syndesmosis which has been looped and tightened through cortical button anchors on either side of the ankle. It does not need removal and thus avoids subsequent surgery. This trial compares these two treatment methods for syndesmotic injuries of the ankle.
Read the detailed description
Patients 18-70 years presenting to one of the two hospitals with an acute syndesmotic injury are eligible for inclusion. 50 patients are randomised to two treatment groups: One group receives a Tightrope (R) fixation and the other receives a quadricortical screw fixation which is removed after 12 weeks. Follow-up intervals are at 6 weeks, 6, 12 and 24 months with standardised CT scans postoperatively and at 12, 24 months and 5 years clinical end-ponts/scores.
- Conditions
- Syndesmotic Injury of the Ankle
- Being tested
- Tightrope Syndesmosis Repair Kit, Syndesmotic screw
- Keywords
- Syndesmosis, Injury, Ankle, Fracture
- Medical subject headings
- Wounds and Injuries, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tightrope Syndesmosis Repair KitDevice
Also called Tightrope Syndesmosis Repair Kit, Arthrex; Naples, Florida
Tightrope Syndesmosis Repair Kit
Syndesmotic screwDevice
Also called Cortical screw; Synthes GmbH, Switzerland
Quadricortical syndesmotic screw
| Study group | Role | What they receive |
|---|---|---|
| Tightrope | Active comparator | Treatment with Tightrope Syndesmosis Repair Kit Receives: Device: Tightrope Syndesmosis Repair Kit |
| Syndesmotic screw | Active comparator | Treatment with a quadricortical syndesmotic screw Receives: Device: 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: 5 years
Secondary outcomes (4)
Olerud-Molander Ankle (OMA) Score
Measured: 5 years
Dorsiflexion angle
According to Lindsjø
Measured: 5 years
Health-related quality of life (EQ-5D)
Measured: 5 years
CT measurements of syndesmotic distance
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2015
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Syndesmotic Injury of the AnkleStudies 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
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset Asker og Baerum
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital
- Responsible party
- Principal investigator, Wender Figved, Sykehuset Asker og Baerum
- Investigators
- Wender Figved, MD, PhD, Study director, Baerum Hospital, Vestre Viken, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01275924
- Sponsor's protocol ID
- TIGHTROPE-SS
- Acronym
- TIGHTROPE-SS
- Status last verified
- Apr 2018
- First submitted
- 11 Jan 2011
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tightrope or Screw Fixation of Acute Tibiofibular Syndesmotic Injury. Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT01275924
- Acronym / sponsor ID
- TIGHTROPE-SS / TIGHTROPE-SS
- Conditions
- Syndesmotic Injury of the Ankle
- Keywords
- Syndesmosis, Injury, Ankle, Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Sykehuset Asker og BaerumUniversity, hospital or other
- Collaborators
- Oslo University Hospital
- Study start
- Jan 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 13 Jan 2011 (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.
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 Tightrope Syndesmosis Repair Kit (Arthrex; Naples, Florida). is used for the same indication, it consists of a heavy suture placed across the syndesmosis which has been looped and tightened through cortical button anchors on either side of the ankle. It does not need removal and thus avoids subsequent surgery. This trial compares these two treatment methods for syndesmotic injuries of the ankle.
Detailed description
Patients 18-70 years presenting to one of the two hospitals with an acute syndesmotic injury are eligible for inclusion. 50 patients are randomised to two treatment groups: One group receives a Tightrope (R) fixation and the other receives a quadricortical screw fixation which is removed after 12 weeks. Follow-up intervals are at 6 weeks, 6, 12 and 24 months with standardised CT scans postoperatively and at 12, 24 months and 5 years clinical end-ponts/scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tightrope | Active comparator | Device: Tightrope Syndesmosis Repair KitTreatment with Tightrope Syndesmosis Repair Kit |
| Syndesmotic screw | Active comparator | Device: Syndesmotic screwTreatment with a quadricortical 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 or without Weber type C fracture
Key exclusion criteria (7 listed)
- Prior injury of the same ankle
- Severe injury of 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 |
|---|---|---|
| Tightrope Syndesmosis Repair KitAlso: Tightrope Syndesmosis Repair Kit, Arthrex; Naples, FloridaTightrope Syndesmosis Repair Kit | Device | Tightrope |
| Syndesmotic screwAlso: Cortical screw; Synthes GmbH, SwitzerlandQuadricortical syndesmotic screw | Device | Syndesmotic screw |
Primary outcome
OTA Score (Modified American Orthopaedic Foot and Ankle Society ankle hind foot score)
Time frame: 5 years
Modified American Orthopaedic Foot and Ankle Society ankle hind foot score (0-100)
4 secondary outcomes
Olerud-Molander Ankle (OMA) Score
Time frame: 5 years
Dorsiflexion angle
Time frame: 5 years
Health-related quality of life (EQ-5D)
Time frame: 5 years
CT measurements of syndesmotic distance
Time frame: 5 years
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 18 Apr 2018.
Related trials for Syndesmotic Injury of the Ankle
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
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.
Wender Figved, MD, PhD study director
Baerum Hospital, Vestre Viken, Norway
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tightrope Syndesmosis Repair Kit and Syndesmotic screw in people with Syndesmotic Injury of the Ankle, run by Sykehuset Asker og Baerum at 2 sites 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 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2018.