Hip FracturesNCT04441723
Comparison of Dynamic Versus Static Lag Screw Modes for Cephalomedullary Nails Used to Fix Intertrochanteric Fragility Fractures
A study testing Osteosynthesis with Gamma 3 nail , using a dynamic lag screw as a proximal fixation. and Osteosynthesis with Gamma 3 nail , using a static lag screw as a proximal fixation. in people with Hip Fractures, run by Instituto Traumatologico Dr. Teodoro Gebauer Weisser at 1 site in Chile.
Trial summary
The objective of this study is to compare the failure rate between two modes of fixing the lag screw of the cephalomedullary nail. The sample studied will be patients who have been diagnosed with a fragility intertrochanteric fracture. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Osteosynthesis with Gamma 3 nail , using a dynamic lag screw as a proximal fixation. and Osteosynthesis with Gamma 3 nail , using a static lag screw as a proximal fixation.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChile
- Study dates
- 11 Jan 2020to 30 Jul 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, 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
- A fracture due to malignancy
- Previous contralateral fracture
- Inability to walk before the fracture
- An inability to comply with rehabilitation
- Follow-up of less than 6 months
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Instituto Traumatologico
Santiago
Pablo Suarez, MD, +56961572181, pablosuarez088@gmail.com
Enrique Cifuentes, MD
About this study
Official title: Comparison of Dynamic Versus Static Lag Screw Modes for Cephalomedullary Nails Used to Fix Peritrochanteric Fragility Fractures
The objective of this study is to compare the failure rate between two modes of fixing the lag screw of the cephalomedullary nail.
The sample studied will be patients who have been diagnosed with a fragility intertrochanteric fracture.
Investigators hypothesis is that the dynamic mode will have a lower failure rate compared to the static mode.
Read the detailed description
Intertrochanteric fragility fractures are one of the most frequent fractures in the elderly . They produce great disability and complications in our patients and they are recognized worldwide as a major public health problem.
The treatment that presents the best results is surgical treatment, since it reduces the mortality of the patients and allows early loading . Thus, avoids secondary complications to the prostration state such as pneumonia, bedsores, pulmonary embolisms, among others.
Currently, the treatment that has shown the best clinical and biomechanical results is osteosynthesis with a cephalomedullary nail, which despite having good results is not free from complications such as implant failure, loss of femoral offset.
Changes are constantly made in the design and surgical techniques of these implants in order to decrease the rate of complications.
This study will particularly assess whether there is any difference in the complication rate between dynamic versus static lag screw modes.
Biomechanical studies that compare these two lag screw modes show that axial and lateral stiffness of the femur-nail construction is greater in static mode than in dynamic modes and the torsional stiffness is greater in dynamic mode than in static modes.
There are no studies comparing the clinical results of these two variants.
- Conditions
- Hip Fractures
- Being tested
- Osteosynthesis with Gamma 3 nail , using a dynamic lag screw as a proximal fixation., Osteosynthesis with Gamma 3 nail , using a static lag screw as a proximal fixation.
- Keywords
- Hip fractures, Intertrochanteric fractures, Cephalomedullary Nails, Cut-out, Cut through
- 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 Gamma 3 nail , using a dynamic lag screw as a proximal fixation.Device
Closed reduction and surgical stabilization of intertrochanteric hip fractures using Gamma 3 nail , with dynamic lag screw as proximal fixation
Osteosynthesis with Gamma 3 nail , using a static lag screw as a proximal fixation.Device
Closed reduction and surgical stabilization of intertrochanteric hip fractures using Gamma 3 nail , with static lag screw as proximal fixation
| Study group | Role | What they receive |
|---|---|---|
| lag screw with dynamic mode | Active comparator | Device: Gamma 3 nail whit lag screw on dynamic mode Surgical stabilization of intertrochanteric hip fractures using two different lag screw modes Receives: Device: Osteosynthesis with Gamma 3 nail , using a dynamic lag screw as a proximal fixation. |
| lag screw with static mode | Active comparator | Device: Gamma 3 nail whit lag screw on dynamic mode Surgical stabilization of intertrochanteric hip fractures using two different lag screw modes Receives: Device: Osteosynthesis with Gamma 3 nail , using a static lag screw 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.
Measured: 6 months
Secondary outcomes (2)
Complications
Rate of Infection and Non Union.
Measured: 3 weeks, 3 months , 6 months
Offset
Changes in femoral offset
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start11 Jan 2020
- Primary completion1 Feb 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Traumatologico Dr. Teodoro Gebauer Weisser
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441723
- Sponsor's protocol ID
- STVSDY
- Status last verified
- Jun 2020
- First submitted
- 18 Jun 2020
- Last updated
- 24 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Kuzyk PR, Shah S, Zdero R, Olsen M, Waddell JP, Schemitsch EH. A biomechanical comparison of static versus dynamic lag screw modes for cephalomedullary nails used to fix unstable peritrochanteric fractures. J Trauma Acute Care Surg. 2012 Feb;72(2):E65-70. doi: 10.1097/ta.0b013e3182170823.
PubMed 22439235Mahomed N, Harrington I, Kellam J, Maistrelli G, Hearn T, Vroemen J. Biomechanical analysis of the Gamma nail and sliding hip screw. Clin Orthop Relat Res. 1994 Jul;(304):280-8.
PubMed 8020229Bhandari M, Swiontkowski M. Management of Acute Hip Fracture. N Engl J Med. 2017 Nov 23;377(21):2053-2062. doi: 10.1056/NEJMcp1611090. No abstract available.
PubMed 29166235
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dynamic Versus Static Lag Screw Modes for Cephalomedullary Nails Used to Fix Peritrochanteric Fragility Fractures
- ClinicalTrials.gov ID
- NCT04441723
- Acronym / sponsor ID
- STVSDY
- Conditions
- Hip Fractures
- Keywords
- Hip fractures, Intertrochanteric fractures, Cephalomedullary Nails, Cut-out, Cut through
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Instituto Traumatologico Dr. Teodoro Gebauer WeisserUniversity, hospital or other
- Study start
- 11 Jan 2020 (actual)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 22 Jun 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 objective of this study is to compare the failure rate between two modes of fixing the lag screw of the cephalomedullary nail.
The sample studied will be patients who have been diagnosed with a fragility intertrochanteric fracture.
Investigators hypothesis is that the dynamic mode will have a lower failure rate compared to the static mode.
Detailed description
Intertrochanteric fragility fractures are one of the most frequent fractures in the elderly . They produce great disability and complications in our patients and they are recognized worldwide as a major public health problem.
The treatment that presents the best results is surgical treatment, since it reduces the mortality of the patients and allows early loading . Thus, avoids secondary complications to the prostration state such as pneumonia, bedsores, pulmonary embolisms, among others.
Currently, the treatment that has shown the best clinical and biomechanical results is osteosynthesis with a cephalomedullary nail, which despite having good results is not free from complications such as implant failure, loss of femoral offset.
Changes are constantly made in the design and surgical techniques of these implants in order to decrease the rate of complications.
This study will particularly assess whether there is any difference in the complication rate between dynamic versus static lag screw modes.
Biomechanical studies that compare these two lag screw modes show that axial and lateral stiffness of the femur-nail construction is greater in static mode than in dynamic modes and the torsional stiffness is greater in dynamic mode than in static modes.
There are no studies comparing the clinical results of these two variants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lag screw with dynamic mode | Active comparator | Device: Osteosynthesis with Gamma 3 nail , using a dynamic lag screw as a proximal fixation.Device: Gamma 3 nail whit lag screw on dynamic mode Surgical stabilization of intertrochanteric hip fractures using two different lag screw modes |
| lag screw with static mode | Active comparator | Device: Osteosynthesis with Gamma 3 nail , using a static lag screw as a proximal fixation.Device: Gamma 3 nail whit lag screw on dynamic mode Surgical stabilization of intertrochanteric hip fractures using two different lag screw modes |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, 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 (5 listed)
- A fracture due to malignancy
- Previous contralateral fracture
- Inability to walk before the fracture
- An inability to comply with rehabilitation
- Follow-up of less than 6 months
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 Gamma 3 nail , using a dynamic lag screw as a proximal fixation.Closed reduction and surgical stabilization of intertrochanteric hip fractures using Gamma 3 nail , with dynamic lag screw as proximal fixation | Device | lag screw with dynamic mode |
| Osteosynthesis with Gamma 3 nail , using a static lag screw as a proximal fixation.Closed reduction and surgical stabilization of intertrochanteric hip fractures using Gamma 3 nail , with static lag screw as proximal fixation | Device | lag screw with static mode |
Primary outcome
Implant failure
Time frame: 6 months
Rate of cut out , cut through.
2 secondary outcomes
Complications
Time frame: 3 weeks, 3 months , 6 months
Offset
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2020.
- Background: PubMed 22439235Kuzyk PR, Shah S, Zdero R, Olsen M, Waddell JP, Schemitsch EH. A biomechanical comparison of static versus dynamic lag screw modes for cephalomedullary nails used to fix unstable peritrochanteric fractures. J Trauma Acute Care Surg. 2012 Feb;72(2):E65-70. doi: 10.1097/ta.0b013e3182170823.
- Background: PubMed 8020229Mahomed N, Harrington I, Kellam J, Maistrelli G, Hearn T, Vroemen J. Biomechanical analysis of the Gamma nail and sliding hip screw. Clin Orthop Relat Res. 1994 Jul;(304):280-8.
- Background: PubMed 29166235Bhandari M, Swiontkowski M. Management of Acute Hip Fracture. N Engl J Med. 2017 Nov 23;377(21):2053-2062. doi: 10.1056/NEJMcp1611090. No abstract available.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteosynthesis with Gamma 3 nail , using a dynamic lag screw as a proximal fixation. and Osteosynthesis with Gamma 3 nail , using a static lag screw as a proximal fixation. in people with Hip Fractures, run by Instituto Traumatologico Dr. Teodoro Gebauer Weisser at 1 site in Chile.
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 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 24 Jun 2020. 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 Chile. 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 Pablo Suarez, MD (+56961572181, pablosuarez088@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 NCT04441723, which also lists 3 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 24 Jun 2020.