SurgeryPhase 2NCT00300989
Inion OTPS Biodegradable Fixation System for the Ankle
A Phase 2 study testing Inion OTPS Biodegradable Fixation System in people with Surgery, run by Inion Oy at 1 site in Finland.
Trial summary
The purpose of the investigation is to compare post-operative fracture and wound healing using Inion OTPS Biodegradable Fixation System implants versus Conventional metal implants. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Surgery
- What is being tested?
- Inion OTPS Biodegradable Fixation System
- Type of treatment
- Medical device
- How many people
- 43 participants
- Where
- 1 siteFinland
- Study dates
- Dec 2005to May 2007
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Distal fibular fracture including either instabile/dislocated Weber class B or any Weber class C fracture OR bimalloelar fracture with lateral malloelus fracture and medial malleolus fracture OR trimalleolar fracture with lateral and medial malleolus fractures and posterior malleolus fracture with less than 1/4 of the articulas surface fractured
- Fresh/acute fracture
- Aged between 18 and 60 years
Who cannot join
- Contraindication for the Inion OTPS Biodegradable Fixation System:Active or potential infection,patient's conditions, limited blood supply, insufficient quantity or quality of bone,where patient cooperation can not be quaranteed
- Multiple trauma
- Previous ankle fracture
- Pregnancy
- Bone malignancy
- Any clinically significant condition based on investigators judgement
- high-load bearing applications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind,Randomised,Prospective Clinical Investigation to Compare Post-Operative Fracture Healing Using the Inion OTPS Biodegradable Fixation System Versus Conventional Metal Screws and Plates in the Treatment of Ankle Fractures.
The purpose of the investigation is to compare post-operative fracture and wound healing using Inion OTPS Biodegradable Fixation System implants versus Conventional metal implants.
- Conditions
- Surgery
- Being tested
- Inion OTPS Biodegradable Fixation System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inion OTPS Biodegradable Fixation SystemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional performance will be determined by using Kaikkonen Functional Scale (Kaikkonen et. al. 1994) and Olerud and Molander Ankle Score (Olerud and Molander 1984) at 12 months post-operatively.
Secondary outcomes (1)
Sequential post-operative radiographs at 12 months post-operatively; Timepoints for returning to work and/or sport; Wound healing; SF-36 Questionnaire; Subjective pain evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2006 (estimated)
- Study startDec 2005
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inion Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ole Brink, Principal investigator, Aarhus University HospitalTerho Kainonen, Principal investigator, Turku Universal Central HospitalGeir Stray Andreassen, Principal investigator, Ullevaal University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00300989
- Sponsor's protocol ID
- D93-701 - 002
- Status last verified
- Oct 2007
- First submitted
- 9 Mar 2006
- Last updated
- 5 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind,Randomised,Prospective Clinical Investigation to Compare Post-Operative Fracture Healing Using the Inion OTPS Biodegradable Fixation System Versus Conventional Metal Screws and Plates in the Treatment of Ankle Fractures.
- ClinicalTrials.gov ID
- NCT00300989
- Acronym / sponsor ID
- D93-701 - 002
- Conditions
- Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Inion OyIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Study completion
- May 2007 (actual)
- First posted
- 10 Mar 2006 (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 the investigation is to compare post-operative fracture and wound healing using Inion OTPS Biodegradable Fixation System implants versus Conventional metal implants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Distal fibular fracture including either instabile/dislocated Weber class B or any Weber class C fracture OR bimalloelar fracture with lateral malloelus fracture and medial malleolus fracture OR trimalleolar fracture with lateral and medial malleolus fractures and posterior malleolus fracture with less than 1/4 of the articulas surface fractured
- Fresh/acute fracture
- Aged between 18 and 60 years
Key exclusion criteria (7 listed)
- Contraindication for the Inion OTPS Biodegradable Fixation System:Active or potential infection,patient's conditions, limited blood supply, insufficient quantity or quality of bone,where patient cooperation can not be quaranteed
- Multiple trauma
- Previous ankle fracture
- Pregnancy
- Bone malignancy
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 |
|---|---|---|
| Inion OTPS Biodegradable Fixation System | Device | – |
Primary outcome
Functional performance will be determined by using Kaikkonen Functional Scale (Kaikkonen et. al. 1994) and Olerud and Molander Ankle Score (Olerud and Molander 1984) at 12 months post-operatively.
1 secondary outcome
Sequential post-operative radiographs at 12 months post-operatively; Timepoints for returning to work and/or sport; Wound healing; SF-36 Questionnaire; Subjective pain evaluation
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 5 Oct 2007.
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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.
Ole Brink principal investigator
Aarhus University Hospital
Terho Kainonen principal investigator
Turku Universal Central Hospital
Geir Stray Andreassen principal investigator
Ullevaal 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 Inion OTPS Biodegradable Fixation System in people with Surgery, run by Inion Oy 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 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 5 Oct 2007. 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?
Functional performance will be determined by using Kaikkonen Functional Scale (Kaikkonen et. al. 1994) and Olerud and Molander Ankle Score (Olerud and Molander 1984) at 12 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 5 Oct 2007.