Fracture of HumerusNCT02826538
3D Geplante Osteosynthesen Mit Patientenspezifischen Zielvorrichtungen
A study testing fracture fixation with patient specific guides and standard procedure of fracture fixation in people with Fracture of Humerus and Fracture of Ulna Radius, run by Balgrist University Hospital at 2 sites in Switzerland.
Trial summary
Goal of this study is to evaluate the accuracy of 3D computer-planned fracture fixation with patient-specific instruments for clavicle, upper extremity, lower extremity and pelvis fractures compared with the standard procedure of fracture fixation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture of Humerus, Fracture of Ulna Radius, Fracture of Clavicle
- What is being tested?
- fracture fixation with patient specific guides and standard procedure of fracture fixation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 30 Jul 2017to 10 May 2019
- 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
- fracture of clavicle, upper extremity, lower extremity or pelvis,tibia, fibula,Femur, with indication for fracture Fixation
- clinical indication for a computed tomography of the fractured bone
- >18 years of Age
- Patient is able to give informed consent
Who cannot join
- pregnancy or nursing women
- non-compliance of the patient to follow the clinical study protocol, drug abuse or alcohol abuse
- participation in a different clinical Trial within the last 30 days before inclusion or during the study
- allergy to Polyamid PA 2200
- no available technique for fracture Fixation which could be performed, in case of applying the medical device is not possible.
- Applying the medical device is not possible, because of technical or anatomical reasons.
- other clinical significant accompanying symptoms (tumor, infection)
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Universital Hospital Zurich
Zurich, 8001
University Hospital Balgrist
Zurich, 8008
About this study
Official title: Evaluation Der Intraoperativen Umsetzung Von 3D Geplanten Osteosynthesen Mit Patientenspezifischen Zielvorrichtungen Durch Eine Quantitative Postoperative Erfolgskontrolle
Goal of this study is to evaluate the accuracy of 3D computer-planned fracture fixation with patient-specific instruments for clavicle, upper extremity, lower extremity and pelvis fractures compared with the standard procedure of fracture fixation.
Read the detailed description
The research hypothesis is: The medical product permits the fracture fixation of clavicle, upper extremity, lower extremity and pelvis fractures to be more accurate compared with standard procedures of fracture fixation. Accuracy is evaluated by calculating translation and rotation comparing the postoperative 3D model versus the preoperative 3D plan.
Secondary outcome is an assessment of the surgical outcome using validated outcome instruments for each fractured body part like "Patient related wrist Evaluation" (PRWE) scores for distal radial fractures, as well as evaluation of range of motion.
- Conditions
- Fracture of Humerus, Fracture of Ulna Radius, Fracture of Clavicle, Fracture of Hand, Fracture of Pelvis, Fracture of Femur
- Being tested
- fracture fixation with patient specific guides, standard procedure of fracture fixation
- Medical subject headings
- Humeral Fractures, Hip Fractures, Femoral Fractures, Skull Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fracture fixation with patient specific guidesDevice
Also called MyOsteotomy
Using the preoperative computed tomography scan, a 3D planning of the fracture Fixation is made and patient-specific guides for fracure fixation are produced using a 3D Printer. These Patient-specific guides are used for fracture fixation
standard procedure of fracture fixationDevice
the standard procedure of fracure fixation for each fracture localisation is used as a standard of reference
| Study group | Role | What they receive |
|---|---|---|
| patient specific guides | Experimental | fracture fixation with 3D planning and use of patient-specific instruments Receives: Device: fracture fixation with patient specific guides |
| standard procedure | Active comparator | standard procedure of fracture Fixation without 3D planning and without use of patient-specific instruments Receives: Device: standard procedure of fracture fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
3D difference between preoperative plan and surgery
For each surgery the discrepancy of the postoperative result compared to the preoperative planning is calculated by measuring all 6 degrees of freedom (3xrotation, 3xtranslation). The discrepancy between a simulated perfect postoperative result and the actual postoperative result is assessed in degree (rotation) and millimeters (translation). These measures are used to compare the outcome of the two different study Groups.
Measured: 12 months
Secondary outcomes (2)
surgical outcome assesed by validated outcome instruments
The surgical outcome is assessed by using specific validated outcome instruments for each fracture localisation, for example PRWE-score for wrist fractures.
Measured: 12 months
range of motion
range of Motion is postoperatively assessed and compared between interventional and control group
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start30 Jul 2017
- Primary completion10 May 2019
- Study completion10 May 2019
Why it stopped: difficulties recruiting participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture of HumerusStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Sponsor
- Investigators
- Phillipp Furnstahl, PhD, Principal investigator, Balgrist University HospitalPhilipp Furnstahl, PhD, Study director, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02826538
- Sponsor's protocol ID
- 3D-Osteosynthese-Ziel
- Status last verified
- Jul 2019
- First submitted
- 30 Jun 2016
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Der Intraoperativen Umsetzung Von 3D Geplanten Osteosynthesen Mit Patientenspezifischen Zielvorrichtungen Durch Eine Quantitative Postoperative Erfolgskontrolle
- ClinicalTrials.gov ID
- NCT02826538
- Acronym / sponsor ID
- 3D-Osteosynthese-Ziel
- Conditions
- Fracture of Humerus, Fracture of Ulna Radius, Fracture of Clavicle, Fracture of Hand, Fracture of Pelvis, Fracture of Femur
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulties recruiting participants
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- 30 Jul 2017 (actual)
- Primary completion
- 10 May 2019 (actual)
- Study completion
- 10 May 2019 (actual)
- First posted
- 11 Jul 2016 (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.
Goal of this study is to evaluate the accuracy of 3D computer-planned fracture fixation with patient-specific instruments for clavicle, upper extremity, lower extremity and pelvis fractures compared with the standard procedure of fracture fixation.
Detailed description
The research hypothesis is: The medical product permits the fracture fixation of clavicle, upper extremity, lower extremity and pelvis fractures to be more accurate compared with standard procedures of fracture fixation. Accuracy is evaluated by calculating translation and rotation comparing the postoperative 3D model versus the preoperative 3D plan.
Secondary outcome is an assessment of the surgical outcome using validated outcome instruments for each fractured body part like "Patient related wrist Evaluation" (PRWE) scores for distal radial fractures, as well as evaluation of range of motion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient specific guides | Experimental | Device: fracture fixation with patient specific guidesfracture fixation with 3D planning and use of patient-specific instruments |
| standard procedure | Active comparator | Device: standard procedure of fracture fixationstandard procedure of fracture Fixation without 3D planning and without use of patient-specific instruments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- fracture of clavicle, upper extremity, lower extremity or pelvis,tibia, fibula,Femur, with indication for fracture Fixation
- clinical indication for a computed tomography of the fractured bone
- >18 years of Age
- Patient is able to give informed consent
Key exclusion criteria (7 listed)
- pregnancy or nursing women
- non-compliance of the patient to follow the clinical study protocol, drug abuse or alcohol abuse
- participation in a different clinical Trial within the last 30 days before inclusion or during the study
- allergy to Polyamid PA 2200
- no available technique for fracture Fixation which could be performed, in case of applying the medical device is not possible.
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 fixation with patient specific guidesAlso: MyOsteotomyUsing the preoperative computed tomography scan, a 3D planning of the fracture Fixation is made and patient-specific guides for fracure fixation are produced using a 3D Printer. These Patient-specific guides are used for fracture fixation | Device | patient specific guides |
| standard procedure of fracture fixationthe standard procedure of fracure fixation for each fracture localisation is used as a standard of reference | Device | standard procedure |
Primary outcome
3D difference between preoperative plan and surgery
Time frame: 12 months
For each surgery the discrepancy of the postoperative result compared to the preoperative planning is calculated by measuring all 6 degrees of freedom (3xrotation, 3xtranslation). The discrepancy between a simulated perfect postoperative result and the actual postoperative result is assessed in degree (rotation) and millimeters (translation). These measures are used to compare the outcome of the two different study Groups.
2 secondary outcomes
surgical outcome assesed by validated outcome instruments
Time frame: 12 months
range of motion
Time frame: 12 months
Results and safety
The study was stopped early (reason given: difficulties recruiting participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Individual participant dataSharing planned: Undecided
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Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
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Enrolling by invitation
Comparison of Functional Outcomes Between Triceps Tongue Elevation vs Olecranon Osteotomy in Intra Articular Distal Humerus Fracture (IA-DH) Management
Intra Articular Distal Humerus 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.
Phillipp Furnstahl, PhD principal investigator
Balgrist University Hospital
Philipp Furnstahl, PhD study director
Balgrist University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fracture fixation with patient specific guides and standard procedure of fracture fixation in people with Fracture of Humerus and Fracture of Ulna Radius, run by Balgrist University Hospital at 2 sites in Switzerland.
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 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: stopped early, as of the sponsor's last update on 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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 was stopped early (reason given: difficulties recruiting participants). 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?
3D difference between preoperative plan and surgery (time frame: 12 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 12 Jul 2019.