Hallux ValgusNCT01535144
Comparative Study of Osteosynthesis for Chevron Osteotomy of Hallux Valgus Using Degradable Versus Non-degradable Metallic Device
A study testing Fracture compressing screw ZfW 102 Königsee Implantate GmbH and Fracture compressing screw titanium Königsee Implantate GmbH in people with Hallux Valgus, run by Syntellix AG at 1 site in Germany.
Trial summary
The purpose of the study is to show the equivalence of a new degradable metallic device to a non-degradable metallic device in patients with Hallux Valgus. Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- Fracture compressing screw ZfW 102 Königsee Implantate GmbH and Fracture compressing screw titanium Königsee Implantate GmbH
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2010to Feb 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 40 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female and male patients with an age of 40 to 79 years at the day of surgery
- Symptomatic Hallux Valgus
- Radiological criterium area of proximal joint angle
- Normal motorically functions
- Female patients of childbearing age must be using two reliable contraception methods
Who cannot join
- Previous bone and/or soft tissue surgeries of the the first metatarsal of the respective foot
- BMI > 32
- Cysts of the first metatarsal of the respective foot
- Neurological disorders with modified motorically functions
- Clinical evidence of osteoporosis
- Chronic renal impairment
Show all 10Show fewer
- Known hypersensitivity to components of the implants
- Regular administration of medications containing the metallic elements of the degradable implant
- Pregnant or lactating women
- Current participation in another clinical trial or within 30 days before surgery
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinic for Orthopaedic Surgery (in the Annastift Hospital)
Hanover, Lower Saxony, 30625
About this study
The purpose of the study is to show the equivalence of a new degradable metallic device to a non-degradable metallic device in patients with Hallux Valgus.
- Conditions
- Hallux Valgus
- Being tested
- Fracture compressing screw ZfW 102 Königsee Implantate GmbH, Fracture compressing screw titanium Königsee Implantate GmbH
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fracture compressing screw ZfW 102 Königsee Implantate GmbHDevice
Comparison of two metallic implantable fracture compressing screws
Fracture compressing screw titanium Königsee Implantate GmbHDevice
Comparison of two metallic implantable fracture compressing screws
| Study group | Role | What they receive |
|---|---|---|
| degradable metallic device | Experimental | Not described Receives: Device: Fracture compressing screw ZfW 102 Königsee Implantate GmbH |
| non-degradable metallic device | Active comparator | Not described Receives: Device: Fracture compressing screw titanium Königsee Implantate GmbH |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference of metatarsal angles in degree post surgery and 6 months after surgery
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study startFeb 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syntellix AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henning Windhagen, Prof., MD, Principal investigator, Clinic for Orthopaedic Surgery (in the Annastift Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535144
- Sponsor's protocol ID
- syn09-01
- Status last verified
- Feb 2012
- First submitted
- 1 Feb 2012
- Last updated
- 1 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Osteosynthesis for Chevron Osteotomy of Hallux Valgus Using Degradable Versus Non-degradable Metallic Device
- ClinicalTrials.gov ID
- NCT01535144
- Acronym / sponsor ID
- syn09-01
- Conditions
- Hallux Valgus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Syntellix AGIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 17 Feb 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.
The purpose of the study is to show the equivalence of a new degradable metallic device to a non-degradable metallic device in patients with Hallux Valgus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| degradable metallic device | Experimental | Device: Fracture compressing screw ZfW 102 Königsee Implantate GmbH |
| non-degradable metallic device | Active comparator | Device: Fracture compressing screw titanium Königsee Implantate GmbH |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female and male patients with an age of 40 to 79 years at the day of surgery
- Symptomatic Hallux Valgus
- Radiological criterium area of proximal joint angle
- Normal motorically functions
- Female patients of childbearing age must be using two reliable contraception methods
Key exclusion criteria (10 listed)
- Previous bone and/or soft tissue surgeries of the the first metatarsal of the respective foot
- BMI > 32
- Cysts of the first metatarsal of the respective foot
- Neurological disorders with modified motorically functions
- Clinical evidence of osteoporosis
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 |
|---|---|---|
| Fracture compressing screw ZfW 102 Königsee Implantate GmbHComparison of two metallic implantable fracture compressing screws | Device | degradable metallic device |
| Fracture compressing screw titanium Königsee Implantate GmbHComparison of two metallic implantable fracture compressing screws | Device | non-degradable metallic device |
Primary outcome
difference of metatarsal angles in degree post surgery and 6 months after surgery
Time frame: up to 6 months
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 1 Mar 2012.
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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.
Henning Windhagen, Prof., MD principal investigator
Clinic for Orthopaedic Surgery (in the Annastift 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 Fracture compressing screw ZfW 102 Königsee Implantate GmbH and Fracture compressing screw titanium Königsee Implantate GmbH in people with Hallux Valgus, run by Syntellix AG at 1 site in Germany.
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 5 inclusion and 10 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 1 Mar 2012. 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 Germany. 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?
difference of metatarsal angles in degree post surgery and 6 months after surgery (time frame: up to 6 months). 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 1 Mar 2012.