Fracture of Distal End of RadiusVIPSNCT01670344
Evaluation of an Innovative Medical Device Supporting Orthopedic Surgical Interventions
A study testing Treatment with investigational method (virtual implant positioning system) in people with Fracture of Distal End of Radius, run by Siemens Healthcare QT at 1 site in Germany.
Trial summary
This study is a randomized, controlled, 2-arm, open trial to evaluate an innovative positioning system in the clinical setting of orthopedic surgery. Aim of the study is the validation and comparison of the innovative medical device with the current standard method. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture of Distal End of Radius
- What is being tested?
- Treatment with investigational method (virtual implant positioning system)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2012to Jun 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with diastal fracture of the radius
- Patients with the mentioned fracture and indication for surgical treatment according to national guidelines
- Age >/= 18 years of age
- Patients willing to participate and after having given their informed consent in written form
Who cannot join
- Participation in other interventional clinical trials
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Implant Planning System - A Method to Support Image-guided Surgical Interventions
This study is a randomized, controlled, 2-arm, open trial to evaluate an innovative positioning system in the clinical setting of orthopedic surgery.
Aim of the study is the validation and comparison of the innovative medical device with the current standard method.
- Conditions
- Fracture of Distal End of Radius
- Being tested
- Treatment with investigational method (virtual implant positioning system), Treatment with surgical standard of care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with investigational method (virtual implant positioning system)Procedure or surgery
Treatment with surgical standard of careProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| A | Other | Treatment with investigational method (virtual implant positioning system) Receives: Procedure: Treatment with investigational method (virtual implant positioning system) |
| B | Other | Treatment with surgical standard of care Receives: Procedure: Treatment with surgical standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of screw replacements in both treatments arms
The number of screw replacements in both treatment arms will be assessed to evaluate the investigational method in comparison to the standard of care (arm B)
Measured: Participants will be followed for the duration of the hospital stay, an expected average of 3 days
Secondary outcomes (2)
Comparison of the investigational method to the standard of care regarding radiation time.
Measured: Participants will be followed for the duration of the hospital stay, an expected average of 3 days
Number of adverse events and serious adverse events during the clinical investigarion.
Measured: Participants will be followed for the duration of the hospital stay, an expected average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture of Distal End of RadiusStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siemens Healthcare QT
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kleinszig Gerhard, MSc, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670344
- Sponsor's protocol ID
- 10308644 Final 2.5
- Acronym
- VIPS
- Status last verified
- Jun 2013
- First submitted
- 15 Aug 2012
- Last updated
- 21 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Implant Planning System - A Method to Support Image-guided Surgical Interventions
- ClinicalTrials.gov ID
- NCT01670344
- Acronym / sponsor ID
- VIPS / 10308644 Final 2.5
- Conditions
- Fracture of Distal End of Radius
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Siemens Healthcare QTIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 22 Aug 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 study is a randomized, controlled, 2-arm, open trial to evaluate an innovative positioning system in the clinical setting of orthopedic surgery.
Aim of the study is the validation and comparison of the innovative medical device with the current standard method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Other | Procedure: Treatment with investigational method (virtual implant positioning system)Treatment with investigational method (virtual implant positioning system) |
| B | Other | Procedure: Treatment with surgical standard of careTreatment with surgical standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with diastal fracture of the radius
- Patients with the mentioned fracture and indication for surgical treatment according to national guidelines
- Age >/= 18 years of age
- Patients willing to participate and after having given their informed consent in written form
Key exclusion criteria (2 listed)
- Participation in other interventional clinical trials
- Pregnant or lactating women
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 |
|---|---|---|
| Treatment with investigational method (virtual implant positioning system) | Procedure or surgery | A |
| Treatment with surgical standard of care | Procedure or surgery | B |
Primary outcome
Number of screw replacements in both treatments arms
Time frame: Participants will be followed for the duration of the hospital stay, an expected average of 3 days
The number of screw replacements in both treatment arms will be assessed to evaluate the investigational method in comparison to the standard of care (arm B)
2 secondary outcomes
Comparison of the investigational method to the standard of care regarding radiation time.
Time frame: Participants will be followed for the duration of the hospital stay, an expected average of 3 days
Number of adverse events and serious adverse events during the clinical investigarion.
Time frame: Participants will be followed for the duration of the hospital stay, an expected average of 3 days
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 21 Jun 2013.
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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.
Kleinszig Gerhard, MSc study director
Sponsor GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with investigational method (virtual implant positioning system) in people with Fracture of Distal End of Radius, run by Siemens Healthcare QT 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 4 inclusion and 2 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 21 Jun 2013. 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?
Number of screw replacements in both treatments arms (time frame: Participants will be followed for the duration of the hospital stay, an expected average of 3 days). 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 21 Jun 2013.