Distal Fibular FractureNCT00864877
Comparison of Biodegradable & Metal Plates for Fixing Ankle Fracture
A study testing biodegradable fixation system (Inion OTPS FreedomPlateTM) in people with Distal Fibular Fracture and Bimalleolar Fracture, run by Inion Oy at 1 site in United Kingdom.
Trial summary
A randomised, prospective clinical investigation to compare post-operative fracture healing and complication rate after the fixation of ankle fractures using the Inion OTPS FreedomPlateTM Biodegradable Fixation System versus conventional stainless steel metal screws and plates. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Distal Fibular Fracture, Bimalleolar Fracture, Trimalleolar Fracture
- What is being tested?
- biodegradable fixation system (Inion OTPS FreedomPlateTM)
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2009to Apr 2012
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient is willing and able to understand, sign and date the study-specific, Institutional Review Board/Ethics Committee approved patient informed consent and applicable privacy regulations.
- Patient must require surgical treatment of a ankle fracture, with a distal fibular (i.e., lateral malleolus) fracture (isolated, closed, unilateral, non-comminuted) including either instable/dislocated Weber class B or any Weber class C fracture that cannot be anatomically reconstructed accurately without open procedure, or bimalleolar fracture with lateral malleolus fracture (as described above) and medial malleolus fracture (closed, unilateral, non-comminuted), or trimalleolar fracture with lateral and medial malleolus fractures as described above and posterior malleolus fracture with less than ¼ of the articular surface fractured
- Fresh/acute fractures (seen within seventy-two hours of the injury)
- Aged between 18 to 60 years
- Skeletally mature
- Willingness to accept randomisation either to the test or control group
- Willingness and ability to comply with all investigation procedures pre- and post-operation.
Who cannot join
- Contraindications of operative internal plate fixations
- Contraindications for the Inion OTPS FreedomPlateTM Biodegradable Fixation System:
- active or potential infection
- patient's conditions, including limited blood supply, insufficient quantity or quality of bone, and where patient cooperation cannot be guaranteed (e.g., alcoholism, drug abuse)
- high-load bearing applications
- Multiple trauma, head injury, bilateral lower extremity fractures, upper extremity fractures
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- Any concomitant painful or disabling disease of the lower limb that would interfere with evaluation of the affected ankle
- Previous ankle fracture
- Patients who most likely will not learn to walk with crutches (e.g., due to being severely overweight)
- Bone malignancy
- Osteomyelitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Prospective Clinical Investigation to Compare Post-Operative Fracture Healing and Complication Rate After the Fixation of Ankle Fractures Using the Inion OTPS FreedomPlate Biodegradable Fixation System Versus Conventional Metal Screws and Plates.
A randomised, prospective clinical investigation to compare post-operative fracture healing and complication rate after the fixation of ankle fractures using the Inion OTPS FreedomPlateTM Biodegradable Fixation System versus conventional stainless steel metal screws and plates.
The objectives of the investigation are
- to compare post-operative fracture healing (union rates, time-to-union), and the complication rates (hardware failure, infection) between the two Plating Systems (biodegradable INION OTPS FreedomPlateTM vs. Stainless Steel 3.5 Reconstruction or DCP plate, or 1/3 Semitubular plates) at the clinical setting of Ankle fractures
- to study the safety of the clinical application of the biodegradable plating system of Inion OTPS FreedomPlateTM at the acute Ankle fracture setting.
- Being tested
- biodegradable fixation system (Inion OTPS FreedomPlateTM)
- Keywords
- retrospective, comparison, biodegradable, implant, ankle fracture
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biodegradable fixation system (Inion OTPS FreedomPlateTM)Device
Also called Inion OTPS(tm) FreedomPlate
What is being measured
The primary outcome is the main question the study is designed to answer.
The functional performance will be primarily determined by the Olerud and Molander Ankle Score
Measured: at 2, 6 and 12 weeks, and 12 and 24 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2009 (estimated)
- Study startMay 2009
- Primary completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Fibular FractureStudies 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
Sponsor and investigators
- Lead sponsor
- Inion Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Peter Giannoudis, Professor, Principal investigator, Leeds General Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00864877
- Sponsor's protocol ID
- D355 - 001
- Status last verified
- Mar 2009
- First submitted
- 18 Mar 2009
- Last updated
- 19 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Prospective Clinical Investigation to Compare Post-Operative Fracture Healing and Complication Rate After the Fixation of Ankle Fractures Using the Inion OTPS FreedomPlate Biodegradable Fixation System Versus Conventional Metal Screws and Plates.
- ClinicalTrials.gov ID
- NCT00864877
- Acronym / sponsor ID
- D355 - 001
- Keywords
- retrospective, comparison, biodegradable, implant, ankle fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Inion OyIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Apr 2012 (estimated)
- First posted
- 19 Mar 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.
A randomised, prospective clinical investigation to compare post-operative fracture healing and complication rate after the fixation of ankle fractures using the Inion OTPS FreedomPlateTM Biodegradable Fixation System versus conventional stainless steel metal screws and plates.
The objectives of the investigation are
- to compare post-operative fracture healing (union rates, time-to-union), and the complication rates (hardware failure, infection) between the two Plating Systems (biodegradable INION OTPS FreedomPlateTM vs. Stainless Steel 3.5 Reconstruction or DCP plate, or 1/3 Semitubular plates) at the clinical setting of Ankle fractures
- to study the safety of the clinical application of the biodegradable plating system of Inion OTPS FreedomPlateTM at the acute Ankle fracture setting.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patient is willing and able to understand, sign and date the study-specific, Institutional Review Board/Ethics Committee approved patient informed consent and applicable privacy regulations.
- Patient must require surgical treatment of a ankle fracture, with a distal fibular (i.e., lateral malleolus) fracture (isolated, closed, unilateral, non-comminuted) including either instable/dislocated Weber class B or any Weber class C fracture that cannot be anatomically reconstructed accurately without open procedure, or bimalleolar fracture with lateral malleolus fracture (as described above) and medial malleolus fracture (closed, unilateral, non-comminuted), or trimalleolar fracture with lateral and medial malleolus fractures as described above and posterior malleolus fracture with less than ¼ of the articular surface fractured
- Fresh/acute fractures (seen within seventy-two hours of the injury)
- Aged between 18 to 60 years
- Skeletally mature
Key exclusion criteria (11 listed)
- Contraindications of operative internal plate fixations
- Contraindications for the Inion OTPS FreedomPlateTM Biodegradable Fixation System:
- Multiple trauma, head injury, bilateral lower extremity fractures, upper extremity fractures
- Any concomitant painful or disabling disease of the lower limb that would interfere with evaluation of the affected ankle
- Previous ankle fracture
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 |
|---|---|---|
| biodegradable fixation system (Inion OTPS FreedomPlateTM)Also: Inion OTPS(tm) FreedomPlate | Device | – |
Primary outcome
The functional performance will be primarily determined by the Olerud and Molander Ankle Score
Time frame: at 2, 6 and 12 weeks, and 12 and 24 months post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2009.
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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.
Peter Giannoudis, Professor principal investigator
Leeds General Infirmary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biodegradable fixation system (Inion OTPS FreedomPlateTM) in people with Distal Fibular Fracture and Bimalleolar Fracture, run by Inion Oy at 1 site in United Kingdom.
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 7 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: status not confirmed, as of the sponsor's last update on 19 Mar 2009. 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 United Kingdom. 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?
Results are not available in the source record.
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?
The functional performance will be primarily determined by the Olerud and Molander Ankle Score (time frame: at 2, 6 and 12 weeks, and 12 and 24 months post-operatively). 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 19 Mar 2009.