Hip FracturesNCT04306198
Helical Blade vs Lag Screw Fixation for Cephalomedullary Nailing of Low Energy Intertrochanteric Hip Fractures
A study testing Osteosynthesis with Trochanteric Fixation Nail (TFN), using a lag screw as a proximal fixation. and Osteosynthesis with Trochanteric Fixation Nail (TFN), using a helical blade as a proximal fixation. in people with Hip Fractures, run by Instituto Traumatologico Dr. Teodoro Gebauer Weisser.
Trial summary
The purpose of this study will be to compare the failure and complications rates of and orthopedic implant (Cephalomedullary Nail) fixed with two different options actually available: lag screw or helical blade. The study population will be patient who have been diagnosed with an intertrochanteric hip fracture. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Osteosynthesis with Trochanteric Fixation Nail (TFN), using a lag screw as a proximal fixation. and Osteosynthesis with Trochanteric Fixation Nail (TFN), using a helical blade as a proximal fixation.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Mar 2020to Nov 2021
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Low Energy Mechanism
- Hip fracture classified as 31.A1.2 - 31 A1.3 and 31.A2 in the AO classification (year 2018)
Who cannot join
- Medical contraindication to surgery
- A fracture due to malignancy
- Peri implant fractures
- Inability to walk before the fracture
- An inability to comply with rehabilitation
- Non-ambulatory pre-fracture
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Helical Blade vs Lag Screw Fixation for Cephalomedullary Nailing of Low Energy Intertrochanteric Hip Fractures: Are There Differences in the Failure Rate? A Prospective, Randomized Study
The purpose of this study will be to compare the failure and complications rates of and orthopedic implant (Cephalomedullary Nail) fixed with two different options actually available: lag screw or helical blade.
The study population will be patient who have been diagnosed with an intertrochanteric hip fracture.
Hypothesis: Our hypothesis is that the helical blade will have a higher failure rate compared to the lag screw
Read the detailed description
Hip fractures in the elderly are recognized worldwide as a major public health problem, its incidence is increasing and it is expected to have 6,26 million cases per year worldwide by 2050.
Surgical treatment is recognized as the best option in these patients because it allows early rehabilitation and decreases mortality and complications.
Currently, the fixation with a cephalomedullary nail is the most commonly used treatment, since it has some mechanical advantages compared to other fixation methods and achieves adequate stability allowing early weight bearing and rehabilitation with low failure rates.
Changes in the design of these implants have tried to reduce the failure rate. The main change has been the introduction of the helical blade for cephalic fixation, instead of a lag screw. The concept behind this modification is that the blade would have greater fixation to the bone and less risk of cut out, because it is supposed to compact the bone around the helical blade instead of removing it.
In spite of some biomechanical studies in cadaveric or artificial models validating this biomechanical advantage, clinical series have shown controversial results. Recently, retrospective clinical studies have shown similar results with the use of the helical blade, and even some studies have shown a higher failure rate compared to the sliding screw.
Currently there is no prospective evidence regarding the failure rate of these two fixation methods. Our objective is to contribute with solid evidence to solve this answer. That is why we have designed a prospective randomized study with strict inclusion criteria, follow up and radiographic measurements.
- Conditions
- Hip Fractures
- Being tested
- Osteosynthesis with Trochanteric Fixation Nail (TFN), using a lag screw as a proximal fixation., Osteosynthesis with Trochanteric Fixation Nail (TFN), using a helical blade as a proximal fixation.
- Keywords
- Hip fractures, Intertrochanteric fractures, Helical blade, Cut-out
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteosynthesis with Trochanteric Fixation Nail (TFN), using a lag screw as a proximal fixation.Device
Closed reduction and surgical stabilization of intertrochanteric hip fractures using Trochanteric Fixation Nail (TFN), with lag screw as proximal fixation
Osteosynthesis with Trochanteric Fixation Nail (TFN), using a helical blade as a proximal fixation.Device
Closed reduction and surgical stabilization of intertrochanteric hip fractures using Trochanteric Fixation Nail (TFN), with helical blade as proximal fixation
| Study group | Role | What they receive |
|---|---|---|
| Lag Screw | Active comparator | Device: Trochanteric Fixation Nail (TFN) whit lag screw Surgical stabilization of intertrochanteric hip fractures using two different proximal fixation implants Receives: Device: Osteosynthesis with Trochanteric Fixation Nail (TFN), using a lag screw as a proximal fixation. |
| Helical Blade | Active comparator | Device: Trochanteric Fixation Nail (TFN) whit helical blade Surgical stabilization of intertrochanteric hip fractures using two different proximal fixation implants Receives: Device: Osteosynthesis with Trochanteric Fixation Nail (TFN), using a helical blade as a proximal fixation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Failure
Rate of cut out , cut through, varus collapse
Measured: 6 months
Secondary outcomes (2)
Complications
Rate of Infection and Non Union.
Measured: 3 weeks, 3 months , 6 months
Parker Mobility score
Score , Minimum value 0 , maximum value 9 , higher scores mean a better outcome.
Measured: 3 months , 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study startMar 2020 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionNov 2021 (estimated)
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 Hip FracturesStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Traumatologico Dr. Teodoro Gebauer Weisser
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomas Amenabar MD, Instituto Traumatologico Dr. Teodoro Gebauer Weisser
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306198
- Sponsor's protocol ID
- 1937
- Status last verified
- Mar 2020
- First submitted
- 4 Mar 2020
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Cooper C, Campion G, Melton LJ 3rd. Hip fractures in the elderly: a world-wide projection. Osteoporos Int. 1992 Nov;2(6):285-9. doi: 10.1007/BF01623184.
PubMed 1421796Sommers MB, Roth C, Hall H, Kam BC, Ehmke LW, Krieg JC, Madey SM, Bottlang M. A laboratory model to evaluate cutout resistance of implants for pertrochanteric fracture fixation. J Orthop Trauma. 2004 Jul;18(6):361-8. doi: 10.1097/00005131-200407000-00006.
PubMed 15213501Al-Munajjed AA, Hammer J, Mayr E, Nerlich M, Lenich A. Biomechanical characterisation of osteosyntheses for proximal femur fractures: helical blade versus screw. Stud Health Technol Inform. 2008;133:1-10.
PubMed 18376008Ibrahim I, Appleton PT, Wixted JJ, DeAngelis JP, Rodriguez EK. Implant cut-out following cephalomedullary nailing of intertrochanteric femur fractures: Are helical blades to blame? Injury. 2019 Apr;50(4):926-930. doi: 10.1016/j.injury.2019.02.015. Epub 2019 Feb 20.
PubMed 30885393
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helical Blade vs Lag Screw Fixation for Cephalomedullary Nailing of Low Energy Intertrochanteric Hip Fractures: Are There Differences in the Failure Rate? A Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT04306198
- Acronym / sponsor ID
- 1937
- Conditions
- Hip Fractures
- Keywords
- Hip fractures, Intertrochanteric fractures, Helical blade, Cut-out
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Instituto Traumatologico Dr. Teodoro Gebauer WeisserUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 12 Mar 2020 (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 purpose of this study will be to compare the failure and complications rates of and orthopedic implant (Cephalomedullary Nail) fixed with two different options actually available: lag screw or helical blade.
The study population will be patient who have been diagnosed with an intertrochanteric hip fracture.
Hypothesis: Our hypothesis is that the helical blade will have a higher failure rate compared to the lag screw
Detailed description
Hip fractures in the elderly are recognized worldwide as a major public health problem, its incidence is increasing and it is expected to have 6,26 million cases per year worldwide by 2050.
Surgical treatment is recognized as the best option in these patients because it allows early rehabilitation and decreases mortality and complications.
Currently, the fixation with a cephalomedullary nail is the most commonly used treatment, since it has some mechanical advantages compared to other fixation methods and achieves adequate stability allowing early weight bearing and rehabilitation with low failure rates.
Changes in the design of these implants have tried to reduce the failure rate. The main change has been the introduction of the helical blade for cephalic fixation, instead of a lag screw. The concept behind this modification is that the blade would have greater fixation to the bone and less risk of cut out, because it is supposed to compact the bone around the helical blade instead of removing it.
In spite of some biomechanical studies in cadaveric or artificial models validating this biomechanical advantage, clinical series have shown controversial results. Recently, retrospective clinical studies have shown similar results with the use of the helical blade, and even some studies have shown a higher failure rate compared to the sliding screw.
Currently there is no prospective evidence regarding the failure rate of these two fixation methods. Our objective is to contribute with solid evidence to solve this answer. That is why we have designed a prospective randomized study with strict inclusion criteria, follow up and radiographic measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lag Screw | Active comparator | Device: Osteosynthesis with Trochanteric Fixation Nail (TFN), using a lag screw as a proximal fixation.Device: Trochanteric Fixation Nail (TFN) whit lag screw Surgical stabilization of intertrochanteric hip fractures using two different proximal fixation implants |
| Helical Blade | Active comparator | Device: Osteosynthesis with Trochanteric Fixation Nail (TFN), using a helical blade as a proximal fixation.Device: Trochanteric Fixation Nail (TFN) whit helical blade Surgical stabilization of intertrochanteric hip fractures using two different proximal fixation implants |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Low Energy Mechanism
- Hip fracture classified as 31.A1.2 - 31 A1.3 and 31.A2 in the AO classification (year 2018)
Key exclusion criteria (6 listed)
- Medical contraindication to surgery
- A fracture due to malignancy
- Peri implant fractures
- Inability to walk before the fracture
- An inability to comply with rehabilitation
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 |
|---|---|---|
| Osteosynthesis with Trochanteric Fixation Nail (TFN), using a lag screw as a proximal fixation.Closed reduction and surgical stabilization of intertrochanteric hip fractures using Trochanteric Fixation Nail (TFN), with lag screw as proximal fixation | Device | Lag Screw |
| Osteosynthesis with Trochanteric Fixation Nail (TFN), using a helical blade as a proximal fixation.Closed reduction and surgical stabilization of intertrochanteric hip fractures using Trochanteric Fixation Nail (TFN), with helical blade as proximal fixation | Device | Helical Blade |
Primary outcome
Implant Failure
Time frame: 6 months
Rate of cut out , cut through, varus collapse
2 secondary outcomes
Complications
Time frame: 3 weeks, 3 months , 6 months
Parker Mobility score
Time frame: 3 months , 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Results publication: PubMed 1421796Cooper C, Campion G, Melton LJ 3rd. Hip fractures in the elderly: a world-wide projection. Osteoporos Int. 1992 Nov;2(6):285-9. doi: 10.1007/BF01623184.
- Results publication: PubMed 15213501Sommers MB, Roth C, Hall H, Kam BC, Ehmke LW, Krieg JC, Madey SM, Bottlang M. A laboratory model to evaluate cutout resistance of implants for pertrochanteric fracture fixation. J Orthop Trauma. 2004 Jul;18(6):361-8. doi: 10.1097/00005131-200407000-00006.
- Results publication: PubMed 18376008Al-Munajjed AA, Hammer J, Mayr E, Nerlich M, Lenich A. Biomechanical characterisation of osteosyntheses for proximal femur fractures: helical blade versus screw. Stud Health Technol Inform. 2008;133:1-10.
- Results publication: PubMed 30885393Ibrahim I, Appleton PT, Wixted JJ, DeAngelis JP, Rodriguez EK. Implant cut-out following cephalomedullary nailing of intertrochanteric femur fractures: Are helical blades to blame? Injury. 2019 Apr;50(4):926-930. doi: 10.1016/j.injury.2019.02.015. Epub 2019 Feb 20.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Osteosynthesis with Trochanteric Fixation Nail (TFN), using a lag screw as a proximal fixation. and Osteosynthesis with Trochanteric Fixation Nail (TFN), using a helical blade as a proximal fixation. in people with Hip Fractures, run by Instituto Traumatologico Dr. Teodoro Gebauer Weisser.
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 6 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 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Tomas Amenabar, MD (+56991594716, tomasamenabar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Failure (time frame: 6 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 NCT04306198, 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 12 Mar 2020.