Femoral FractureESINNCT01673048
Modification of ESIN-osteosynthesis in a Femoral Fracture Model and Its Transmission to Clinical Practice
A study testing 3-Nail-ESIN in femoral shaft fractures in people with Femoral Fracture and Children, run by University of Luebeck at 1 site in Germany.
Trial summary
Elastic stable intramedullary nailing (ESIN) is the standard treatment for displaced diaphyseal femoral fractures in children. However, some literature report high complication rates (10-50%) in complex fractures. Data of our own patients with special emphasis on complications showed also mediocre results. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Femoral Fracture, Children
- What is being tested?
- 3-Nail-ESIN in femoral shaft fractures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2009to Dec 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 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Dislocated femoral fracture
- ESIN osteosynthesis
Who cannot join
- No given informed consent
- Other osteosynthesis than ESIN
Trial locations and contacts
1 site in 1 country.
About this study
Official title: From Bench to Bedside: Modification of Elastic Stable Intramedullary Nailing With a 3rd Nail in a Femoral Spiral Fracture Model and Its Transmission to Clinical Practice
Elastic stable intramedullary nailing (ESIN) is the standard treatment for displaced diaphyseal femoral fractures in children. However, some literature report high complication rates (10-50%) in complex fractures. Data of our own patients with special emphasis on complications showed also mediocre results. Thus, a biomechanical study was conducted to search for modifications. In this study the stiffness with a 3rd nail implanted was compared to the classical 2 C-shaped configuration. For each of the 3 configurations of retrograde ESIN (titanium nails) eight composite femoral grafts (Sawbones®) with an identical spiral fracture were used: 2C configuration (2 C-shaped nails, 2x3.5 mm), 3CM configuration (3rd from antero-medial, + 1x2.5 mm) and 3CL configuration (3rd from antero-lateral, + 1x2.5 mm). Each group underwent biomechanical testing in 4-point bending, IRO/ERO and axial compression (0°/9°). Due to a significantly higher stiffness of 3CL in the anterior-posterior, internal rotation and 9° compression directions implantation of 3 nails became standard treatment for all dislocated femoral fractures at our department.
All patients were followed prospectively. The following data was collected: Type of osteosynthesis, any kind of complication (additional procedures like cast or external fixateur, Re-Do operations, misalignment, pseudarthrosis, skin irritation, infection), time until full weight bearing and time until implant removal. At follow-up the legs were controlled for a possible length discrepancy and a possible deviation of axis. Patients' satisfaction was controlled by CSQ (clients satisfaction score, Larsen et al 2002). Further on the Harris Hip Score was used. X-ray controls were done as standard care protocol after 1 and 3-4 months (dependend on age).
Level of Evidence IV Keywords: Elastic stable intramedullary nailing, biomechanical testing, fracture, femur, treatment, children, adolescents.
Read the detailed description
see above
- Conditions
- Femoral Fracture, Children
- Being tested
- 3-Nail-ESIN in femoral shaft fractures
- Keywords
- Elastic stable intramedullary nailing, biomechanical testing, fracture, femur, treatment, children, adolescents
- Medical subject headings
- Femoral Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-Nail-ESIN in femoral shaft fracturesProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Femoral fracture, ESIN | Active comparator | Prospectively all patients treated with the 3-nail-configuration for dislocated femoral shaft fractures were enrolled; 25 patients are planned, 18 could be enrolled Comparison will be with own previous data of patients treated with the "classical" 2-C-shaped ESIN-osteosynthesis Receives: Procedure: 3-Nail-ESIN in femoral shaft fractures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative and postoperative complications
All complications will be recorded: Intraoperative and postoperative complications, Re-Do operations
Measured: 12 months
Secondary outcomes (2)
misalignment
Follow up X-rays will be measured for misalignment in degrees (sagittal, frontal and transverse plane) Data will be grouped as
- 1 - 5° b) 6 - 10° c) 11 - 15° d)16 - 20° e) 20 - 30° f) > 30°
Measured: 12 m
Pseudarthrosis
Measured: 12 m
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2012 (estimated)
- Study startJan 2009
- Primary completionOct 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Femoral FractureStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin M Kaiser, University of Luebeck
- Investigators
- Martin M Kaiser, PD Dr. med., Principal investigator, University Luebeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673048
- Sponsor's protocol ID
- 3ESINFemur
- Acronym
- ESIN
- Status last verified
- Feb 2014
- First submitted
- 12 Aug 2012
- Last updated
- 14 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kaiser MM, Zachert G, Wendlandt R, Eggert R, Stratmann C, Gros N, Schulze-Hessing M, Rapp M. Increasing stability by pre-bending the nails in elastic stable intramedullary nailing: a biomechanical analysis of a synthetic femoral spiral fracture model. J Bone Joint Surg Br. 2012 May;94(5):713-8. doi: 10.1302/0301-620X.94B5.28247.
PubMed 22529097Kaiser MM, Zachert G, Wendlandt R, Rapp M, Eggert R, Stratmann C, Wessel LM, Schulz AP, Kienast BJ. Biomechanical analysis of a synthetic femoral spiral fracture model: Do end caps improve retrograde flexible intramedullary nail fixation? J Orthop Surg Res. 2011 Sep 18;6:46. doi: 10.1186/1749-799X-6-46.
PubMed 21923948Kaiser MM, Wessel LM, Zachert G, Stratmann C, Eggert R, Gros N, Schulze-Hessing M, Kienast B, Rapp M. Biomechanical analysis of a synthetic femur spiral fracture model: Influence of different materials on the stiffness in flexible intramedullary nailing. Clin Biomech (Bristol). 2011 Jul;26(6):592-7. doi: 10.1016/j.clinbiomech.2011.01.012. Epub 2011 Feb 22.
PubMed 21345557Kaiser MM, Stratmann C, Zachert G, Schulze-Hessing M, Gros N, Eggert R, Rapp M. Modification of elastic stable intramedullary nailing with a 3rd nail in a femoral spiral fracture model - results of biomechanical testing and a prospective clinical study. BMC Musculoskelet Disord. 2014 Jan 8;15:3. doi: 10.1186/1471-2474-15-3.
PubMed 24397612
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Bench to Bedside: Modification of Elastic Stable Intramedullary Nailing With a 3rd Nail in a Femoral Spiral Fracture Model and Its Transmission to Clinical Practice
- ClinicalTrials.gov ID
- NCT01673048
- Acronym / sponsor ID
- ESIN / 3ESINFemur
- Conditions
- Femoral Fracture, Children
- Keywords
- Elastic stable intramedullary nailing, biomechanical testing, fracture, femur, treatment, children, adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 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.
Elastic stable intramedullary nailing (ESIN) is the standard treatment for displaced diaphyseal femoral fractures in children. However, some literature report high complication rates (10-50%) in complex fractures. Data of our own patients with special emphasis on complications showed also mediocre results. Thus, a biomechanical study was conducted to search for modifications. In this study the stiffness with a 3rd nail implanted was compared to the classical 2 C-shaped configuration. For each of the 3 configurations of retrograde ESIN (titanium nails) eight composite femoral grafts (Sawbones®) with an identical spiral fracture were used: 2C configuration (2 C-shaped nails, 2x3.5 mm), 3CM configuration (3rd from antero-medial, + 1x2.5 mm) and 3CL configuration (3rd from antero-lateral, + 1x2.5 mm). Each group underwent biomechanical testing in 4-point bending, IRO/ERO and axial compression (0°/9°). Due to a significantly higher stiffness of 3CL in the anterior-posterior, internal rotation and 9° compression directions implantation of 3 nails became standard treatment for all dislocated femoral fractures at our department.
All patients were followed prospectively. The following data was collected: Type of osteosynthesis, any kind of complication (additional procedures like cast or external fixateur, Re-Do operations, misalignment, pseudarthrosis, skin irritation, infection), time until full weight bearing and time until implant removal. At follow-up the legs were controlled for a possible length discrepancy and a possible deviation of axis. Patients' satisfaction was controlled by CSQ (clients satisfaction score, Larsen et al 2002). Further on the Harris Hip Score was used. X-ray controls were done as standard care protocol after 1 and 3-4 months (dependend on age).
Level of Evidence IV Keywords: Elastic stable intramedullary nailing, biomechanical testing, fracture, femur, treatment, children, adolescents.
Detailed description
see above
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Femoral fracture, ESIN | Active comparator | Procedure: 3-Nail-ESIN in femoral shaft fracturesProspectively all patients treated with the 3-nail-configuration for dislocated femoral shaft fractures were enrolled; 25 patients are planned, 18 could be enrolled Comparison will be with own previous data of patients treated with the "classical" 2-C-shaped ESIN-osteosynthesis |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Dislocated femoral fracture
- ESIN osteosynthesis
Key exclusion criteria (2 listed)
- No given informed consent
- Other osteosynthesis than ESIN
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 |
|---|---|---|
| 3-Nail-ESIN in femoral shaft fractures | Procedure or surgery | Femoral fracture, ESIN |
Primary outcome
Intraoperative and postoperative complications
Time frame: 12 months
All complications will be recorded: Intraoperative and postoperative complications, Re-Do operations
2 secondary outcomes
misalignment
Time frame: 12 m
Pseudarthrosis
Time frame: 12 m
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 14 Feb 2014.
- Background: PubMed 22529097Kaiser MM, Zachert G, Wendlandt R, Eggert R, Stratmann C, Gros N, Schulze-Hessing M, Rapp M. Increasing stability by pre-bending the nails in elastic stable intramedullary nailing: a biomechanical analysis of a synthetic femoral spiral fracture model. J Bone Joint Surg Br. 2012 May;94(5):713-8. doi: 10.1302/0301-620X.94B5.28247.
- Background: PubMed 21923948Kaiser MM, Zachert G, Wendlandt R, Rapp M, Eggert R, Stratmann C, Wessel LM, Schulz AP, Kienast BJ. Biomechanical analysis of a synthetic femoral spiral fracture model: Do end caps improve retrograde flexible intramedullary nail fixation? J Orthop Surg Res. 2011 Sep 18;6:46. doi: 10.1186/1749-799X-6-46.
- Background: PubMed 21345557Kaiser MM, Wessel LM, Zachert G, Stratmann C, Eggert R, Gros N, Schulze-Hessing M, Kienast B, Rapp M. Biomechanical analysis of a synthetic femur spiral fracture model: Influence of different materials on the stiffness in flexible intramedullary nailing. Clin Biomech (Bristol). 2011 Jul;26(6):592-7. doi: 10.1016/j.clinbiomech.2011.01.012. Epub 2011 Feb 22.
- Results publication: PubMed 24397612Kaiser MM, Stratmann C, Zachert G, Schulze-Hessing M, Gros N, Eggert R, Rapp M. Modification of elastic stable intramedullary nailing with a 3rd nail in a femoral spiral fracture model - results of biomechanical testing and a prospective clinical study. BMC Musculoskelet Disord. 2014 Jan 8;15:3. doi: 10.1186/1471-2474-15-3.
- Department of Pediatric Surgery LuebeckLink provided by the sponsor.
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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.
Martin M Kaiser, PD Dr. med. principal investigator
University Luebeck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-Nail-ESIN in femoral shaft fractures in people with Femoral Fracture and Children, run by University of Luebeck 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 2 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 14 Feb 2014. 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?
Intraoperative and postoperative complications (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01673048, which also lists 4 linked publications.
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 14 Feb 2014.