Fracture Tibia3DFRGNCT05741892
3D Planned Surgery of Acute Fractures Performed With 3D Guides Printed at the Point of Care
A study testing Fracture reposition with 3D printed patient specific repositions guides in people with Fracture Tibia and Fracture Femur, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The aim of the study is to assess the accuracy of fracture reduction performed with surgical guides designed and 3D printed at the point of care in comminuted fractures of femur- and tibia-shaft. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Fracture Tibia, Fracture Femur, Fracture, Comminuted
- What is being tested?
- Fracture reposition with 3D printed patient specific repositions guides
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2023to 1 Dec 2025
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 99 years
- Comminuted shaft fracture of tibia or femur
- Intact contralateral tibia or femur
- Patient willing to participate and sign the informed consent
- Clear indication of surgical treatment
Who cannot join
- Refusal to sign the informed consent
- Abnormal contralateral bony anatomy (previous surgeries, poliomyelitis, previous injury, implants)
- Pregnancy
- Acute tumor or previous tumor disease
- Acute infection
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Universitätsklinik für Orthopädische Chirurgie und Traumatologie
Bern, 3010
Andreas Hecker, MD, 031 632 21 11 ext. 0041, andreas.hecker@insel.ch
Silvan Hess, MD
About this study
Official title: 3D Planned Surgery of Acute Fractures Performed With 3D Guides Printed at the Point of Care - a Prospective Case Series
The aim of the study is to assess the accuracy of fracture reduction performed with surgical guides designed and 3D printed at the point of care in comminuted fractures of femur- and tibia-shaft.
Read the detailed description
The 3D planning of surgeries and their execution with 3D printed templates adapted to the individual patient is an established procedure for elective surgeries such as corrective osteotomies for mal-united fractures. Currently, the planning and production of 3D templates are performed mainly by external companies. The duration until delivery usually exceeds four weeks. Therefore, it is not possible to use them in acute cases (e.g. acute fractures) that need to be treated surgically within a few days.
The most frequent postoperative deformity in long bone shaft fractures is malrotation. In femoral fractures, clinically relevant rotational errors (>15°) occur in up to 40% of cases after surgical treatment, which either results in a poor clinical outcome or requires revision surgery. In tibial diaphyseal fractures, up to 50% of rotational errors have been reported. The higher the degree of comminution the higher the chances of malrotation postoperatively. Due to the comminuted situation, no reliable bony references exist intraoperatively and the surgeon can only estimate the correct length, axis and, rotation based on the contralateral leg. This ultimately leads to a high number of revision surgeries or poor outcomes. Porcine and human cadaveric feasibility studies conducted by the study team utilizing site 3D planned and printed reduction guides showed excellent accuracy of fracture reduction.
This project aims to apply this technique to the clinical setting by conducting a clinical study. The accuracy of 3D planned surgery performed with surgical guides designed and printed at the point of care will be assessed and the complication rate will be compared to the known literature.
It was hypothesized that the mean deviation between the measured postoperative rotational alignment and planned rotation alignment in patients treated for comminuted fractures of femur- and tibia-shaft treated using 3D printed reposition guides will be less than 5°. Additionally, it was hypothesized that the rate of clinically relevant deviations between postoperative rotational alignment (e.g. 15°) and planned rotation in patients treated for comminuted fractures of femur- and tibia-shaft treated using 3D printed reposition guides will be less than 10%.
- Conditions
- Fracture Tibia, Fracture Femur, Fracture, Comminuted
- Being tested
- Fracture reposition with 3D printed patient specific repositions guides
- Keywords
- Femur, Tibia, Comminuted fracture, 3D printing, personalized medicine
- Medical subject headings
- Tibial Fractures, Femoral Fractures, Fractures, Comminuted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fracture reposition with 3D printed patient specific repositions guidesDevice
Comminuted tibial- or/and femur shaft fractures will be treated using 3D printed patient-specific repositions guides.
| Study group | Role | What they receive |
|---|---|---|
| 3D fracture reposition guide group | Experimental | Comminuted tibial- or/and femur shaft fractures will be treated using 3D printed patient-specific repositions guides. Receives: Device: Fracture reposition with 3D printed patient specific repositions guides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rotational deviation (Axial plane deviation) in degree
Planned rotational alignment versus postoperative rotational alignment.
Measured: Between 1 to 7 days postoperative, depending on the patients status
Secondary outcomes (3)
Length deviation in mm
Planed length versus postoperative length
Measured: Between 1 to 7 days postoperative, depending on the patients status
Frontal plane deviation in degree
Planned varus/valgus alignment versus postoperative varus/valgus alignment
Measured: Between 1 to 7 days postoperative, depending on the patients status
Sagittal plane deviation in degree
Planned flexion/extension of the proximal and distal fracture fragments compared to the postoperative position.
Measured: Between 1 to 7 days postoperative, depending on the patients status
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start1 Apr 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture TibiaStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective case series
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hecker Andreas, MD, Principal investigator, Universitätsklinik für Orthopädische Chirurgie und Traumatologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741892
- Sponsor's protocol ID
- 5364
- Acronym
- 3DFRG
- Status last verified
- Dec 2023
- First submitted
- 13 Feb 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Planned Surgery of Acute Fractures Performed With 3D Guides Printed at the Point of Care - a Prospective Case Series
- ClinicalTrials.gov ID
- NCT05741892
- Acronym / sponsor ID
- 3DFRG / 5364
- Conditions
- Fracture Tibia, Fracture Femur, Fracture, Comminuted
- Keywords
- Femur, Tibia, Comminuted fracture, 3D printing, personalized medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 23 Feb 2023 (actual)
- 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 aim of the study is to assess the accuracy of fracture reduction performed with surgical guides designed and 3D printed at the point of care in comminuted fractures of femur- and tibia-shaft.
Detailed description
The 3D planning of surgeries and their execution with 3D printed templates adapted to the individual patient is an established procedure for elective surgeries such as corrective osteotomies for mal-united fractures. Currently, the planning and production of 3D templates are performed mainly by external companies. The duration until delivery usually exceeds four weeks. Therefore, it is not possible to use them in acute cases (e.g. acute fractures) that need to be treated surgically within a few days.
The most frequent postoperative deformity in long bone shaft fractures is malrotation. In femoral fractures, clinically relevant rotational errors (>15°) occur in up to 40% of cases after surgical treatment, which either results in a poor clinical outcome or requires revision surgery. In tibial diaphyseal fractures, up to 50% of rotational errors have been reported. The higher the degree of comminution the higher the chances of malrotation postoperatively. Due to the comminuted situation, no reliable bony references exist intraoperatively and the surgeon can only estimate the correct length, axis and, rotation based on the contralateral leg. This ultimately leads to a high number of revision surgeries or poor outcomes. Porcine and human cadaveric feasibility studies conducted by the study team utilizing site 3D planned and printed reduction guides showed excellent accuracy of fracture reduction.
This project aims to apply this technique to the clinical setting by conducting a clinical study. The accuracy of 3D planned surgery performed with surgical guides designed and printed at the point of care will be assessed and the complication rate will be compared to the known literature.
It was hypothesized that the mean deviation between the measured postoperative rotational alignment and planned rotation alignment in patients treated for comminuted fractures of femur- and tibia-shaft treated using 3D printed reposition guides will be less than 5°. Additionally, it was hypothesized that the rate of clinically relevant deviations between postoperative rotational alignment (e.g. 15°) and planned rotation in patients treated for comminuted fractures of femur- and tibia-shaft treated using 3D printed reposition guides will be less than 10%.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective case series
| Arm | Type | Receives |
|---|---|---|
| 3D fracture reposition guide group | Experimental | Device: Fracture reposition with 3D printed patient specific repositions guidesComminuted tibial- or/and femur shaft fractures will be treated using 3D printed patient-specific repositions guides. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 99 years
- Comminuted shaft fracture of tibia or femur
- Intact contralateral tibia or femur
- Patient willing to participate and sign the informed consent
- Clear indication of surgical treatment
Key exclusion criteria (5 listed)
- Refusal to sign the informed consent
- Abnormal contralateral bony anatomy (previous surgeries, poliomyelitis, previous injury, implants)
- Pregnancy
- Acute tumor or previous tumor disease
- Acute infection
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 reposition with 3D printed patient specific repositions guidesComminuted tibial- or/and femur shaft fractures will be treated using 3D printed patient-specific repositions guides. | Device | 3D fracture reposition guide group |
Primary outcome
Rotational deviation (Axial plane deviation) in degree
Time frame: Between 1 to 7 days postoperative, depending on the patients status
Planned rotational alignment versus postoperative rotational alignment.
3 secondary outcomes
Length deviation in mm
Time frame: Between 1 to 7 days postoperative, depending on the patients status
Frontal plane deviation in degree
Time frame: Between 1 to 7 days postoperative, depending on the patients status
Sagittal plane deviation in degree
Time frame: Between 1 to 7 days postoperative, depending on the patients status
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Hecker Andreas, MD principal investigator
Universitätsklinik für Orthopädische Chirurgie und Traumatologie
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 reposition with 3D printed patient specific repositions guides in people with Fracture Tibia and Fracture Femur, run by Insel Gruppe AG, University Hospital Bern at 1 site 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 5 inclusion and 5 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 6 Dec 2023. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hecker Andreas, MD (031 632 21 11 ext. 0041, andreas.hecker@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rotational deviation (Axial plane deviation) in degree (time frame: Between 1 to 7 days postoperative, depending on the patients status). 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 6 Dec 2023.