Unstable Lisfranc Fracture-dislocations of the MidfootPhase 4LisfrancNCT00985023
A Comparison of Stainless Steel and Bioabsorbable Screw Fixation of Lisfranc Foot Injuries
A Phase 4 study testing Steel screw fixation of Lisfranc fracture-dislocation. and Absorbable screw fixation of Lisfranc fracture-dislocations. in people with Unstable Lisfranc Fracture-dislocations of the Midfoot, run by Rothman Institute Orthopaedics at 2 sites in United States.
Trial summary
The Lisfranc ligaments are a group of ligaments that connect the bones of the middle portion of the foot to each other. The Lisfranc ligaments allow for a normal and stable range of motion and shape to the foot. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Unstable Lisfranc Fracture-dislocations of the Midfoot
- What is being tested?
- Steel screw fixation of Lisfranc fracture-dislocation. and Absorbable screw fixation of Lisfranc fracture-dislocations.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2008to Aug 2016
- Phase
- Phase 4
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects will be adults of any gender or race.
- The underlying diagnosis will be a Lisfranc foot injury.
- The indication for fixing the Lisfranc ligaments is abnormal separation of the middle part of the foot from each other.
- Subjects will have received either a steel or absorbable screw to fix the Lisfranc ligaments.
Who cannot join
- Subjects must not have intact or normal Lisfranc ligaments in the foot.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Riddle Memorial Hospital
Media, Pennsylvania, 19063
Nazareth Hospital
Philadelphia, Pennsylvania, 19152
About this study
Official title: A Randomized, Prospective Comparison of Stainless Steel and Bioabsorbable Screw Fixation of Lisfranc Foot Injuries
The Lisfranc ligaments are a group of ligaments that connect the bones of the middle portion of the foot to each other. The Lisfranc ligaments allow for a normal and stable range of motion and shape to the foot. In certain foot fractures where the Lisfranc ligaments are damaged, the constraint and stability it had given to the middle of the foot is lost. Attempted activity at the foot will result in pain and abnormal motion. If injury to the Lisfranc ligaments is left untreated, the eventual end result is foot arthritis and deformity.
The current standard orthopaedic treatment of foot fractures with Lisfranc ligament injuries is surgery. The foot fractures are fixed with metal screws. The Lisfranc ligaments are fixed by compressing the space between the middle bones of the foot with steel screws. These screws allow for ligament healing. As the ligaments heal, the patient should not resume activity with the fixed foot too soon as the screw may break. Upon breakage, the ligament repair may fail and the screw is now difficult to surgically remove. Regardless of breakage, a second surgical procedure is often recommended to remove the steel screw 6 months after foot surgery. This allows for a complete return of normal foot range of motion, but at the cost of a second surgical procedure.
The investigators hypothesize that absorbable screw fixation of the Lisfranc ligaments does not yield significant differences in postoperative foot stability, ligament function, and symptoms when compared to steel screw fixation. In addition, absorbable screw fixation of the Lisfranc ligaments offers the advantage that a second surgical procedure to remove the screw is not necessary.
Read the detailed description
The Lisfranc ligaments are a group of ligaments that connect the bones of the middle portion of the foot to each other. The Lisfranc ligaments allow for a normal and stable range of motion and shape to the foot.
In certain foot fractures, the Lisfranc ligaments are damaged. When the Lisfranc ligaments are disrupted, the constraint and stability it had given to the middle of the foot is lost. Attempted activity at the foot will result in pain and abnormal motion. If injury to the Lisfranc ligaments is left untreated, the eventual end result is foot arthritis and deformity.
The current standard orthopaedic treatment of foot fractures with Lisfranc ligament injuries is surgery. The foot fractures are fixed with metal screws. The Lisfranc ligaments are fixed by compressing the space between the middle bones of the foot with steel screws. These screws allow for ligament healing. As the ligaments heal, the patient should not resume activity with the fixed foot too soon as the screw may break. Upon breakage, the ligament repair may fail and the screw is now difficult to surgically remove. Regardless of breakage, a second surgical procedure is often recommended to remove the steel screw 6 months after foot surgery. This allows for a complete return of normal foot range of motion, but at the cost of a second surgical procedure.
The use of materials that can be absorbed by the human body to fix the Lisfranc ligaments has only been studied in 1 paper. One such material is the Smart Screw (Bionx, Blue Bell, Pennsylvania) which is approved by the Food and Drug Administration (F.D.A.) and made of polylevolactic acid (PLA). Absorbable screws could be ideal for the treatment of Lisfranc ligament injuries. They can provide a mechanical scaffold to allow for ligament healing. They are absorbable which eliminates the need for a second surgery to remove a screw. They can be used for foot injuries where the rate of healing and thus absorption is rapid. Although, absorbable implants are weaker than metal implants, the absorbable screw can be protected from breaking by restricting weight bearing after surgery. If the absorbable screw does break, there is no need to remove the fragments in the foot bones as they are absorbable.
Comparing the long-term results of fixing the Lisfranc ligaments with either a steel or absorbable screw is important as there are no studies on the subject to date. There is only 1 published study regarding absorbable screws to fix the Lisfranc ligaments. The purpose of this study is to compare the outcome of steel and absorbable screw fixation of the Lisfranc ligaments in foot injuries in two surgeons' practice.
We hypothesize that absorbable screw fixation of the Lisfranc ligaments does not yield significant differences in postoperative foot stability, ligament function, and symptoms when compared to steel screw fixation. In addition, absorbable screw fixation of the Lisfranc ligaments offers the advantage that a second surgical procedure to remove the screw is not necessary.
- Being tested
- Steel screw fixation of Lisfranc fracture-dislocation., Absorbable screw fixation of Lisfranc fracture-dislocations.
- Keywords
- Unstable, Lisfranc, fracture, dislocation, midfoot
- Medical subject headings
- Fractures, Bone, Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steel screw fixation of Lisfranc fracture-dislocation.Procedure or surgery
Also called Steel screw
Stainless steel screw fixation of unstable Lisfranc fracture-dislocations of the midfoot.
Absorbable screw fixation of Lisfranc fracture-dislocations.Procedure or surgery
Also called Smart Screw
Bioabsorbable (poly-levo-lactic acid) screw fixation of unstable Lisfranc fracture-dislocations of the midfoot.
| Study group | Role | What they receive |
|---|---|---|
| Steel screw fixation | Active comparator | Not described Receives: Procedure: Steel screw fixation of Lisfranc fracture-dislocation. |
| Bioabsorbable screw fixation | Experimental | Not described Receives: Procedure: Absorbable screw fixation of Lisfranc fracture-dislocations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to pre-injury level of function.
Measured: 2 years
Secondary outcomes (1)
Restoration of normal midfoot alignment and stability.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2009 (estimated)
- Study startAug 2008
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unstable Lisfranc Fracture-dislocations of the MidfootStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamal Ahmad, Rothman Institute Orthopaedics
- Investigators
- Jamal Ahmad, M.D., Principal investigator, Rothman Institute Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00985023
- Sponsor's protocol ID
- Lisfranc
- Acronym
- Lisfranc
- Status last verified
- Jan 2017
- First submitted
- 23 Sep 2009
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective Comparison of Stainless Steel and Bioabsorbable Screw Fixation of Lisfranc Foot Injuries
- ClinicalTrials.gov ID
- NCT00985023
- Acronym / sponsor ID
- Lisfranc / Lisfranc
- Keywords
- Unstable, Lisfranc, fracture, dislocation, midfoot
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 25 Sep 2009 (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 Lisfranc ligaments are a group of ligaments that connect the bones of the middle portion of the foot to each other. The Lisfranc ligaments allow for a normal and stable range of motion and shape to the foot. In certain foot fractures where the Lisfranc ligaments are damaged, the constraint and stability it had given to the middle of the foot is lost. Attempted activity at the foot will result in pain and abnormal motion. If injury to the Lisfranc ligaments is left untreated, the eventual end result is foot arthritis and deformity.
The current standard orthopaedic treatment of foot fractures with Lisfranc ligament injuries is surgery. The foot fractures are fixed with metal screws. The Lisfranc ligaments are fixed by compressing the space between the middle bones of the foot with steel screws. These screws allow for ligament healing. As the ligaments heal, the patient should not resume activity with the fixed foot too soon as the screw may break. Upon breakage, the ligament repair may fail and the screw is now difficult to surgically remove. Regardless of breakage, a second surgical procedure is often recommended to remove the steel screw 6 months after foot surgery. This allows for a complete return of normal foot range of motion, but at the cost of a second surgical procedure.
The investigators hypothesize that absorbable screw fixation of the Lisfranc ligaments does not yield significant differences in postoperative foot stability, ligament function, and symptoms when compared to steel screw fixation. In addition, absorbable screw fixation of the Lisfranc ligaments offers the advantage that a second surgical procedure to remove the screw is not necessary.
Detailed description
The Lisfranc ligaments are a group of ligaments that connect the bones of the middle portion of the foot to each other. The Lisfranc ligaments allow for a normal and stable range of motion and shape to the foot.
In certain foot fractures, the Lisfranc ligaments are damaged. When the Lisfranc ligaments are disrupted, the constraint and stability it had given to the middle of the foot is lost. Attempted activity at the foot will result in pain and abnormal motion. If injury to the Lisfranc ligaments is left untreated, the eventual end result is foot arthritis and deformity.
The current standard orthopaedic treatment of foot fractures with Lisfranc ligament injuries is surgery. The foot fractures are fixed with metal screws. The Lisfranc ligaments are fixed by compressing the space between the middle bones of the foot with steel screws. These screws allow for ligament healing. As the ligaments heal, the patient should not resume activity with the fixed foot too soon as the screw may break. Upon breakage, the ligament repair may fail and the screw is now difficult to surgically remove. Regardless of breakage, a second surgical procedure is often recommended to remove the steel screw 6 months after foot surgery. This allows for a complete return of normal foot range of motion, but at the cost of a second surgical procedure.
The use of materials that can be absorbed by the human body to fix the Lisfranc ligaments has only been studied in 1 paper. One such material is the Smart Screw (Bionx, Blue Bell, Pennsylvania) which is approved by the Food and Drug Administration (F.D.A.) and made of polylevolactic acid (PLA). Absorbable screws could be ideal for the treatment of Lisfranc ligament injuries. They can provide a mechanical scaffold to allow for ligament healing. They are absorbable which eliminates the need for a second surgery to remove a screw. They can be used for foot injuries where the rate of healing and thus absorption is rapid. Although, absorbable implants are weaker than metal implants, the absorbable screw can be protected from breaking by restricting weight bearing after surgery. If the absorbable screw does break, there is no need to remove the fragments in the foot bones as they are absorbable.
Comparing the long-term results of fixing the Lisfranc ligaments with either a steel or absorbable screw is important as there are no studies on the subject to date. There is only 1 published study regarding absorbable screws to fix the Lisfranc ligaments. The purpose of this study is to compare the outcome of steel and absorbable screw fixation of the Lisfranc ligaments in foot injuries in two surgeons' practice.
We hypothesize that absorbable screw fixation of the Lisfranc ligaments does not yield significant differences in postoperative foot stability, ligament function, and symptoms when compared to steel screw fixation. In addition, absorbable screw fixation of the Lisfranc ligaments offers the advantage that a second surgical procedure to remove the screw is not necessary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Steel screw fixation | Active comparator | Procedure: Steel screw fixation of Lisfranc fracture-dislocation. |
| Bioabsorbable screw fixation | Experimental | Procedure: Absorbable screw fixation of Lisfranc fracture-dislocations. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects will be adults of any gender or race.
- The underlying diagnosis will be a Lisfranc foot injury.
- The indication for fixing the Lisfranc ligaments is abnormal separation of the middle part of the foot from each other.
- Subjects will have received either a steel or absorbable screw to fix the Lisfranc ligaments.
Key exclusion criteria (1 listed)
- Subjects must not have intact or normal Lisfranc ligaments in the foot.
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 |
|---|---|---|
| Steel screw fixation of Lisfranc fracture-dislocation.Also: Steel screwStainless steel screw fixation of unstable Lisfranc fracture-dislocations of the midfoot. | Procedure or surgery | Steel screw fixation |
| Absorbable screw fixation of Lisfranc fracture-dislocations.Also: Smart ScrewBioabsorbable (poly-levo-lactic acid) screw fixation of unstable Lisfranc fracture-dislocations of the midfoot. | Procedure or surgery | Bioabsorbable screw fixation |
Primary outcome
Return to pre-injury level of function.
Time frame: 2 years
1 secondary outcome
Restoration of normal midfoot alignment and stability.
Time frame: 2 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 Jan 2017.
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.
Jamal Ahmad, M.D. principal investigator
Rothman Institute Orthopaedics
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Steel screw fixation of Lisfranc fracture-dislocation. and Absorbable screw fixation of Lisfranc fracture-dislocations. in people with Unstable Lisfranc Fracture-dislocations of the Midfoot, run by Rothman Institute Orthopaedics at 2 sites 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 4 inclusion and 1 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 Jan 2017. 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Return to pre-injury level of function. (time frame: 2 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 Jan 2017.