Lisfranc InjuriesNCT01448941
Arthrodesis Versus Extra-articular Plate Fixation in Lisfranc Injury
A study testing Temporary extraarticular plate fixation, Primary arthrodesis and Primary arthrodesis TMT 2 and 3 in people with Lisfranc Injuries, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to compare arthrodesis of the first TMT-joint to extraarticular bridge plate fixation of the same joint in acute Lisfranc injuries. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lisfranc Injuries
- What is being tested?
- Temporary extraarticular plate fixation, Primary arthrodesis and Primary arthrodesis TMT 2 and 3
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2011to Dec 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lisfranc injuries with instability off TMT1, and fracture/instability of TMT 2 and 3. No major fracture in relation to TMT1.
- Age 18-65
Who cannot join
- Feet with other major foot/ankle injuries
- Previous foot infection or foot pathology on affected side
- Previous surgery to the TMT joints
- Sequelae after previous foot injuries
- Diabetes mellitus, neuropathy and peripheral vascular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arthrodesis Versus Extra-articular Bridge Plating of the First Tarsometatarsal Joint After Acute Lisfranc Injury
The purpose of this study is to compare arthrodesis of the first TMT-joint to extraarticular bridge plate fixation of the same joint in acute Lisfranc injuries.
Read the detailed description
We want to compare arthrodesis of TMT 1 to temporary bridge plating of TMT 1 in acute Lisfranc injuries where at least tarsometatarsal joints 1-3 are involved.
We preform arthrodesis of TMT 2 and 3 in both groups.
- Conditions
- Lisfranc Injuries
- Being tested
- Temporary extraarticular plate fixation, Primary arthrodesis, Primary arthrodesis TMT 2 and 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporary extraarticular plate fixationProcedure or surgery
Arm 1: Primary arthrodesis TMT 1 Arm 2: Temporary extraarticular plate fixation TMT 1
Primary arthrodesisProcedure or surgery
Primary arthrodesis
Primary arthrodesis TMT 2 and 3Procedure or surgery
Primary arthrodesis TMT 2 and 3 when instability is present
| Study group | Role | What they receive |
|---|---|---|
| Primary arthrodesis TMT 1 | Active comparator | Arthrodesis TMT 1 when instability is present. Primary arthrodesis TMT 2 and 3 when instability present Receives: Procedure: Primary arthrodesis; Procedure: Primary arthrodesis TMT 2 and 3 |
| Temporary extraarticular plate fixation | Experimental | Temporary extraarticular plate fixation of TMT 1 when instability is present. Primary arthrodesis TMT 2 and 3 when instability present Receives: Procedure: Temporary extraarticular plate fixation; Procedure: Primary arthrodesis TMT 2 and 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AOFAS Midfoot scale
AOFAS Midfoot scale
Measured: 2 years postoperative
Secondary outcomes (1)
SF-36
SF-36
Measured: 2 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lisfranc InjuriesStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Are Haukåen Stødle, Oslo University Hospital
- Investigators
- Are H Stødle, cand. med., Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448941
- Sponsor's protocol ID
- 206025 (REK-ID)
- Status last verified
- Apr 2018
- First submitted
- 6 Oct 2011
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthrodesis Versus Extra-articular Bridge Plating of the First Tarsometatarsal Joint After Acute Lisfranc Injury
- ClinicalTrials.gov ID
- NCT01448941
- Acronym / sponsor ID
- 206025 (REK-ID)
- Conditions
- Lisfranc Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 7 Oct 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.
The purpose of this study is to compare arthrodesis of the first TMT-joint to extraarticular bridge plate fixation of the same joint in acute Lisfranc injuries.
Detailed description
We want to compare arthrodesis of TMT 1 to temporary bridge plating of TMT 1 in acute Lisfranc injuries where at least tarsometatarsal joints 1-3 are involved.
We preform arthrodesis of TMT 2 and 3 in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary arthrodesis TMT 1 | Active comparator | Procedure: Primary arthrodesis, Procedure: Primary arthrodesis TMT 2 and 3Arthrodesis TMT 1 when instability is present. Primary arthrodesis TMT 2 and 3 when instability present |
| Temporary extraarticular plate fixation | Experimental | Procedure: Temporary extraarticular plate fixation, Procedure: Primary arthrodesis TMT 2 and 3Temporary extraarticular plate fixation of TMT 1 when instability is present. Primary arthrodesis TMT 2 and 3 when instability present |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Lisfranc injuries with instability off TMT1, and fracture/instability of TMT 2 and 3. No major fracture in relation to TMT1.
- Age 18-65
Key exclusion criteria (5 listed)
- Feet with other major foot/ankle injuries
- Previous foot infection or foot pathology on affected side
- Previous surgery to the TMT joints
- Sequelae after previous foot injuries
- Diabetes mellitus, neuropathy and peripheral vascular disease
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 |
|---|---|---|
| Temporary extraarticular plate fixationArm 1: Primary arthrodesis TMT 1 Arm 2: Temporary extraarticular plate fixation TMT 1 | Procedure or surgery | Temporary extraarticular plate fixation |
| Primary arthrodesisPrimary arthrodesis | Procedure or surgery | Primary arthrodesis TMT 1 |
| Primary arthrodesis TMT 2 and 3Primary arthrodesis TMT 2 and 3 when instability is present | Procedure or surgery | Primary arthrodesis TMT 1, Temporary extraarticular plate fixation |
Primary outcome
AOFAS Midfoot scale
Time frame: 2 years postoperative
AOFAS Midfoot scale
1 secondary outcome
SF-36
Time frame: 2 years postoperative
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 9 Mar 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Lisfranc Injuries
Recruiting
Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation
Medial Malleolus Fracture, Lisfranc Injury
Active, not recruiting
Stability and Outcomes of Non-displaced Lisfranc Injuries
Lisfranc Injury, Sprain of Foot
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.
Are H Stødle, cand. med. principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporary extraarticular plate fixation, Primary arthrodesis and Primary arthrodesis TMT 2 and 3 in people with Lisfranc Injuries, run by Oslo University Hospital 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 5 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 9 Mar 2021. 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?
AOFAS Midfoot scale (time frame: 2 years postoperative). 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 9 Mar 2021.