Ankle FracturePhase 2NCT01729195
Ankle Syndesmosis Fixation by Antibiotic Releasing Bioabsorbable Screw
A Phase 2 study testing A ciprofloxacin containing bioabsorbable PLGA bone screw in people with Ankle Fracture, run by Turku University Hospital at 1 site in Finland.
Trial summary
This single-center randomized trial evaluates the efficacy and safety of a new bone screw (antibiotic releasing bioabsorbable screw) in fixation of syndesmosis in patients with Weber C-type ankle fractures. The comparison is made to subjects treated by conventional metal screw fixation of the syndesmosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ankle Fracture
- What is being tested?
- A ciprofloxacin containing bioabsorbable PLGA bone screw
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2006to Jan 2014
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute, closed Weber C-type ankle fracture
- adult patients (age 18-70 years)
- female subjects of child-bearing potential must have a negative pregnancy test and an approved contraception for the study duration
Who cannot join
- a previous fracture or infection of the injured ankle or the ipsilateral foot
- significant associated soft-tissue injury
- other long-bone fracture of the lower extremities
- documented active infection at any anatomic site
- a known metabolic skeletal disease (osteoporosis or osteomalasia) or a medication affecting bone structure (such as corticosteroid treatment)
- a pathological fracture
Show all 11Show fewer
- any underlying systemic disease (such as unbalanced diabetes mellitus or rheumatoid disease) or a condition (such as alcoholism or drug abuse) which are known to affect resistance to infection
- history of prosthetic knee or hip replacement
- pregnant women or nursing mothers
- hypersensitivity to fluoroquinolones or related antibiotics (nalidixine acid)
- any other condition that in the judgment of the investigator would prohibit the subject from participating in the study or may hinder the collection of data and interpretation of the results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Antibiotic Releasing Bone Screw: a Randomized Clinical Trial of Patients With Weber C Type Ankle Fractures
This single-center randomized trial evaluates the efficacy and safety of a new bone screw (antibiotic releasing bioabsorbable screw) in fixation of syndesmosis in patients with Weber C-type ankle fractures. The comparison is made to subjects treated by conventional metal screw fixation of the syndesmosis. The primary objective is to show that the antibiotic releasing bioabsorbable screw is at least as good as the routinely used metal screw in prevention of syndesmosis widening in patients with Weber C-type ankle fractures. The secondary objective is to show that the clinical outcome of the ankle fracture treatment is equal between patients treated by the antibiotic releasing bioabsorbable screw and the conventional metal screw.
Read the detailed description
This is a randomized parallel-group single centre study. All the patients enrolled will have an acute, closed Weber C-type ankle fracture. The ankle syndesmosis will be fixed using the new medical device (antibiotic containing bioabsorbable screw) or the routinely used device (metal screw). The investigational antibiotic containing bioabsorbable screw for ankle syndesmosis repair (the thread diameter 4.5 mm) will be made of bioabsorbable poly(lactide-co-glycolide) (PLGA) 80:20 and ciprofloxacin, which is a bactericidal antibiotic. The main purpose of the screw is to prevent syndesmosis widening after Weber C-type of ankle fracture. The secondary function of the screw is to reduce the risk for colonization of the implant with bacteria and subsequently prevent biomaterial-related infection. In the control group, a stainless steel screw will be used. All patients will receive the standard of care for concomitant fractures and other injuries of the ankle.
The key variables in the assessment will be radiostereometric (RSA) measurements of the syndesmosis width, CT imaging of the ankle mortise and standard radiographic evaluation of the syndesmosis width and ankle mortise. Clinical outcome of the ankle fracture treatment will be measured using standardized outcome questionnaires (RAND-36, AAOS Foot and Ankle Outcome Instrument, Olerud and Molander score, VAS pain scale). The follow-up of the patients will be 52 weeks. The metal screw will be removed 8 weeks after fracture surgery. The expected mechanical integrity of the bioabsorbable screw is 6 - 8 weeks, while the complete absorption time of the bioabsorbable screw in human body is expected to be approximately two years
- Conditions
- Ankle Fracture
- Being tested
- A ciprofloxacin containing bioabsorbable PLGA bone screw
- Keywords
- bioabsorbable implant, bone screw, local antibiotic prophylaxis, syndesmosis injury, ankle fracture, ciprofloxacin
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A ciprofloxacin containing bioabsorbable PLGA bone screwProcedure or surgery
Also called Manufactured in Tampere University of Technology/Bioretec Ltd
The syndesmosis injury will be fixed the antibiotic releasing bioabsorbable bone screw or a standard metal screw. After surgery, the ankle will be immobilized in a cast for 6 weeks. The metal screw will be surgically removed at 8 weeks. The bioabsorbable screw will be left in place.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm | Experimental | The syndesmosis injury of the patients will be fixed with a ciprofloxacin containing bioabsorbable PLGA bone screw or a stainless steel metal screw Receives: Procedure: A ciprofloxacin containing bioabsorbable PLGA bone screw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiostereometric analysis of the width of the syndesmosis
Tantalum markers implanted during surgery into the fibula and tibia. Radiostereometric imaging allows to measure the three-dimensional displacement of the fibula in relation of the tibia.
Measured: up to 12 weeks
Secondary outcomes (1)
Computed tomography in evaluation of the restoration of the normal anatomy
CT imaging allows to evaluate the success in fracture reduction and the maintenance of the restored anatomy during the follow-up
Measured: Before surgery and repated at 0 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startMar 2006
- Primary completionJan 2008
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ankle FractureStudies of the same condition, open and under way.
- More trials run by Turku 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Tampere University of Technology
- Responsible party
- Sponsor
- Investigators
- Hannu T Aro, MD, PhD, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729195
- Sponsor's protocol ID
- A204-CI-1
- Other IDs
- Protocol 15526
- Status last verified
- Feb 2014
- First submitted
- 13 Nov 2012
- Last updated
- 17 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Makinen TJ, Veiranto M, Knuuti J, Jalava J, Tormala P, Aro HT. Efficacy of bioabsorbable antibiotic containing bone screw in the prevention of biomaterial-related infection due to Staphylococcus aureus. Bone. 2005 Feb;36(2):292-9. doi: 10.1016/j.bone.2004.11.009.
PubMed 15780955Makinen TJ, Mattila KT, Maattanen H, Aro HT. Comparison of digital and conventional radiostereometric image analysis in an ankle phantom model. Scand J Surg. 2005;94(3):233-8. doi: 10.1177/145749690509400311.
PubMed 16259174Niemela SM, Ikaheimo I, Koskela M, Veiranto M, Suokas E, Tormala P, Waris T, Ashammakhi N, Syrjala H. Ciprofloxacin-releasing bioabsorbable polymer is superior to titanium in preventing Staphylococcus epidermidis attachment and biofilm formation in vitro. J Biomed Mater Res B Appl Biomater. 2006 Jan;76(1):8-14. doi: 10.1002/jbm.b.30414.
PubMed 16265660Veiranto M, Tormala P, Suokas E. In vitro mechanical and drug release properties of bioabsorbable ciprofloxacin containing and neat self-reinforced P(L/DL)LA 70/30 fixation screws. J Mater Sci Mater Med. 2002 Dec;13(12):1259-63. doi: 10.1023/a:1021187331458.
PubMed 15348674
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Antibiotic Releasing Bone Screw: a Randomized Clinical Trial of Patients With Weber C Type Ankle Fractures
- ClinicalTrials.gov ID
- NCT01729195
- Acronym / sponsor ID
- A204-CI-1
- Conditions
- Ankle Fracture
- Keywords
- bioabsorbable implant, bone screw, local antibiotic prophylaxis, syndesmosis injury, ankle fracture, ciprofloxacin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Tampere University of Technology
- Study start
- Mar 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 20 Nov 2012 (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.
This single-center randomized trial evaluates the efficacy and safety of a new bone screw (antibiotic releasing bioabsorbable screw) in fixation of syndesmosis in patients with Weber C-type ankle fractures. The comparison is made to subjects treated by conventional metal screw fixation of the syndesmosis. The primary objective is to show that the antibiotic releasing bioabsorbable screw is at least as good as the routinely used metal screw in prevention of syndesmosis widening in patients with Weber C-type ankle fractures. The secondary objective is to show that the clinical outcome of the ankle fracture treatment is equal between patients treated by the antibiotic releasing bioabsorbable screw and the conventional metal screw.
Detailed description
This is a randomized parallel-group single centre study. All the patients enrolled will have an acute, closed Weber C-type ankle fracture. The ankle syndesmosis will be fixed using the new medical device (antibiotic containing bioabsorbable screw) or the routinely used device (metal screw). The investigational antibiotic containing bioabsorbable screw for ankle syndesmosis repair (the thread diameter 4.5 mm) will be made of bioabsorbable poly(lactide-co-glycolide) (PLGA) 80:20 and ciprofloxacin, which is a bactericidal antibiotic. The main purpose of the screw is to prevent syndesmosis widening after Weber C-type of ankle fracture. The secondary function of the screw is to reduce the risk for colonization of the implant with bacteria and subsequently prevent biomaterial-related infection. In the control group, a stainless steel screw will be used. All patients will receive the standard of care for concomitant fractures and other injuries of the ankle.
The key variables in the assessment will be radiostereometric (RSA) measurements of the syndesmosis width, CT imaging of the ankle mortise and standard radiographic evaluation of the syndesmosis width and ankle mortise. Clinical outcome of the ankle fracture treatment will be measured using standardized outcome questionnaires (RAND-36, AAOS Foot and Ankle Outcome Instrument, Olerud and Molander score, VAS pain scale). The follow-up of the patients will be 52 weeks. The metal screw will be removed 8 weeks after fracture surgery. The expected mechanical integrity of the bioabsorbable screw is 6 - 8 weeks, while the complete absorption time of the bioabsorbable screw in human body is expected to be approximately two years
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm | Experimental | Procedure: A ciprofloxacin containing bioabsorbable PLGA bone screwThe syndesmosis injury of the patients will be fixed with a ciprofloxacin containing bioabsorbable PLGA bone screw or a stainless steel metal screw |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- acute, closed Weber C-type ankle fracture
- adult patients (age 18-70 years)
- female subjects of child-bearing potential must have a negative pregnancy test and an approved contraception for the study duration
Key exclusion criteria (11 listed)
- a previous fracture or infection of the injured ankle or the ipsilateral foot
- significant associated soft-tissue injury
- other long-bone fracture of the lower extremities
- documented active infection at any anatomic site
- a known metabolic skeletal disease (osteoporosis or osteomalasia) or a medication affecting bone structure (such as corticosteroid treatment)
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 |
|---|---|---|
| A ciprofloxacin containing bioabsorbable PLGA bone screwAlso: Manufactured in Tampere University of Technology/Bioretec LtdThe syndesmosis injury will be fixed the antibiotic releasing bioabsorbable bone screw or a standard metal screw. After surgery, the ankle will be immobilized in a cast for 6 weeks. The metal screw will be surgically removed at 8 weeks. The bioabsorbable screw will be left in place. | Procedure or surgery | Single-arm |
Primary outcome
Radiostereometric analysis of the width of the syndesmosis
Time frame: up to 12 weeks
Tantalum markers implanted during surgery into the fibula and tibia. Radiostereometric imaging allows to measure the three-dimensional displacement of the fibula in relation of the tibia.
1 secondary outcome
Computed tomography in evaluation of the restoration of the normal anatomy
Time frame: Before surgery and repated at 0 and 12 weeks
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 17 Feb 2014.
- Background: PubMed 15780955Makinen TJ, Veiranto M, Knuuti J, Jalava J, Tormala P, Aro HT. Efficacy of bioabsorbable antibiotic containing bone screw in the prevention of biomaterial-related infection due to Staphylococcus aureus. Bone. 2005 Feb;36(2):292-9. doi: 10.1016/j.bone.2004.11.009.
- Background: PubMed 16259174Makinen TJ, Mattila KT, Maattanen H, Aro HT. Comparison of digital and conventional radiostereometric image analysis in an ankle phantom model. Scand J Surg. 2005;94(3):233-8. doi: 10.1177/145749690509400311.
- Background: PubMed 16265660Niemela SM, Ikaheimo I, Koskela M, Veiranto M, Suokas E, Tormala P, Waris T, Ashammakhi N, Syrjala H. Ciprofloxacin-releasing bioabsorbable polymer is superior to titanium in preventing Staphylococcus epidermidis attachment and biofilm formation in vitro. J Biomed Mater Res B Appl Biomater. 2006 Jan;76(1):8-14. doi: 10.1002/jbm.b.30414.
- Background: PubMed 15348674Veiranto M, Tormala P, Suokas E. In vitro mechanical and drug release properties of bioabsorbable ciprofloxacin containing and neat self-reinforced P(L/DL)LA 70/30 fixation screws. J Mater Sci Mater Med. 2002 Dec;13(12):1259-63. doi: 10.1023/a:1021187331458.
- Related InfoLink provided by the sponsor.
Related trials for Ankle Fracture
Not yet recruiting
Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery
Ankle Fractures, Syndesmotic Injury
Recruiting
Investigating Auto Adjusting Dynamic AFO
Lower Limb; Fusion, Congenital, Lower Limb Fracture
Recruiting
Lateral Ankle Treatment
Avulsion Fracture
RecruitingObservational study
Use of Bioresorbable Magnesium Set Screws in Syndesmotic Injuries: a Pilot Study
Syndesmotic Injury, Trimalleolar Fracture
Not yet recruiting
Outpatient Floor Pedal Bike Utilization
Femur Fracture, Tibia Fracture
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.
Hannu T Aro, MD, PhD principal investigator
Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing A ciprofloxacin containing bioabsorbable PLGA bone screw in people with Ankle Fracture, run by Turku University Hospital at 1 site in Finland.
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 11 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 17 Feb 2014. 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 Finland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Radiostereometric analysis of the width of the syndesmosis (time frame: up to 12 weeks). 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 NCT01729195, which also lists 4 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 17 Feb 2014.