Pertrochanteric FractureTFN-ANCT04851509
Static Helical Screw Locking of Pertrochanteric Femur Fractures Using the TFN-A
A study testing Dynamic Rotational Locking and Static Locking in people with Pertrochanteric Fracture, run by Fraser Orthopaedic Research Society at 1 site in Canada.
Trial summary
The study will investigate the shortening and collapse of pertrochanteric fractures following surgical management with the TFN-Advanced nailing system. The focus will be on comparing radiographic assessments of nails which have been statically locked versus dynamically locked. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pertrochanteric Fracture
- What is being tested?
- Dynamic Rotational Locking and Static Locking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 siteCanada
- Study dates
- 17 May 2021to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients >18 years of age
- AO/OTA 31-A fractures who the surgeon deems eligible for treatment with a cephalomedullary nail
- Open and closed fractures
- Ambulatory prior to injury (with or without walking aides)
- Native (non-fractured, no implant) contralateral hip
- Willing and able to sign consent (substitute decision maker)
Who cannot join
- Contralateral hip fracture or hip arthroplasty
- Fracture not amenable to treatment with a cephalomedullary nail
- Non-ambulatory patient
- Fractures >14 days (time of injury to OR)
- Bilateral pertrochanteric hip fractures
- Non-unions
Show all 13Show fewer
- Pathologic fractures
- Periprosthetic fractures
- Patients with spinal injury
- Incarceration
- Pregnancy
- Limited life expectancy due to significant medical co-morbidities or medical contra-indications to surgery
- Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e., patients with no fixed address, report a plan to move out of town, or intellectually challenged patients without adequate family support).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Royal Columbian Hospital/Fraser Health Authority
New Westminster, British Columbia, V3L 3W7
Kyrsten Butterfield, BSc, 604-553-3247, kyrsten.butterfield@fraserhealth.ca
About this study
Official title: Static Helical Screw Locking of Pertrochanteric Femur Fractures Using the TFN-Advanced Proximal Femoral Nailing System - a Randomized Trial
The study will investigate the shortening and collapse of pertrochanteric fractures following surgical management with the TFN-Advanced nailing system. The focus will be on comparing radiographic assessments of nails which have been statically locked versus dynamically locked. This is a randomized control study with the initial invention being randomized to either statically locking or dynamically locking. For a two-month period, all eligible patients will receive the randomized allocated treatment, then treatment will switch to the alternate treatment for the next two months and will continue to alternate treatments for two-month periods until study enrollment has completed.
Read the detailed description
Hip fractures are common injuries in the elderly population that result in significant morbidity and mortality and a significant burden on health care systems. Hip fractures can be treated with arthroplasty or with internal fixation, depending on the fracture pattern. Cephalomedullary nailing (CMN) has become one of the established treatments for intertrochanteric hip fractures with a wide variety of implant designs from many different companies. The TFN-ADVANCED™ Proximal femoral nailing system (TFN-A) is a novel implant for treating intertrochanteric and subtrochanteric proximal femur fractures with a paucity of published literature on the performance of this implant.
A method to decrease the amount of fracture compression is to use the set screw to lock the screw "statically" so it does not slide to the same degree as if the screw is placed in the "dynamic" or sliding position. To the knowledge of the investigators, the role of statically locking the screw to prevent fracture collapse has not been studied. Statically locking CMN to treat hip fractures has become standard of care at the Royal Columbian Hospital with all the investigating surgeons having adopted this practice in an attempt to prevent significant fracture collapse and neck shortening. Anecdotally, the investigators have not seen significant rates of cephalic screw cut-out over the past five years, and believe the investigators' screw cut-out rates are lower than what is reported in the literature. The investigators have been using the Gamma Nail (Stryker) to statically lock the screw as the previous TFN lacked the ability for static locking. However, with the advent of the TFN-A, the investigators have adopted this implant as their long cephalomedullary nail of choice for fixation of pertrochanteric femur fractures.
- Conditions
- Pertrochanteric Fracture
- Being tested
- Dynamic Rotational Locking, Static Locking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Rotational LockingProcedure or surgery
Performed, as per the Synthes technique guide, using the 5mm hex flexible set screwdriver and then loosening the set screw by one-half turn of the screwdriver.
Static LockingProcedure or surgery
Performed by using the torque-limiting set screwdriver and locking the set screw down onto the helical screw to prevent dynamic sliding of the screw within the nail.
| Study group | Role | What they receive |
|---|---|---|
| Dynamic rotational locking | Active comparator | Using a fracture table, the affected leg will be placed into traction and the patient will be prepped and draped in the usual fashion. The fracture will be provisionally reduced using closed techniques. A 3cm incision will be used to gain access to the intramedullary canal and the nail (either a short nail or long nail, at the discretion of the treating surgeon) will be introduced to the femur. The screw will be placed across the fracture and into the femoral head, aiming for a tip-to-apex distance less than 25mm. The compression nut will be used to compress the fracture. The screw will be rotationally locked by using the 5mm hex flexible screwdriver by advancing the set screw until it stops completely. The screw will then be turned counterclockwise by a ½ turn. Receives: Procedure: Dynamic Rotational Locking |
| Static locking | Experimental | Using a fracture table, the affected leg will be placed into traction and the patient will be prepped and draped in the usual fashion. The fracture will be provisionally reduced using closed techniques. A 3cm incision will be used to gain access to the intramedullary canal and the nail (either a short nail or long nail, at the discretion of the treating surgeon) will be introduced to the femur. The screw will be placed across the fracture and into the femoral head, aiming for a tip-to-apex distance of less than 25mm. The compression nut will be used to compress the fracture. The screw will then be statically locked using the 6Nm torque-limiting blue handle with 6mm hex coupling to completely lock the set screw down on the helical screw. Receives: Procedure: Static Locking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Assessment
The primary objective of this study will be to investigate how statically locking the TFN-A influences shortening or collapse of pertrochanteric fractures by measuring radiographic shortening or collapse of pertrochanteric fractures treated with the TFN-A implant.
Measured: 12 months post treatment
Secondary outcomes (4)
Fracture Reduction Quality
Assessed through x-rays of the entire proximal femur
Measured: Intra-operatively
Femoral Offset
Measured in a method described by O. Paul et al
Measured: 1 day post-op, 6 weeks, 12 weeks, 6 months, and 12 months
Tip-Apex distance
Measured as described by Baumgaertner et al
Measured: 1 day post-op, 6 weeks, 12 weeks, 6 months, and 12 months
Complications
SAEs/AEs
Measured: intra-operatively, 1 day post-op, 6 weeks, 12 weeks, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start17 May 2021
- Primary completionJun 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pertrochanteric 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized trial design utilizing alternating treatment allocation to assign patients to treatment arms, treatment allocations will last for two months at a time.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fraser Orthopaedic Research Society
- Sponsor type
- Research network
- Collaborators
- DePuy Synthes
- Responsible party
- Sponsor
- Investigators
- Bertrand Perey, MD, FRCSC, Principal investigator, Royal Columbian Hospital/Fraser Health AuthorityDavid Cinats, MD, Principal investigator, Orthopaedic Surgeon, Fraser Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851509
- Sponsor's protocol ID
- FHREB#: 2021-015
- Acronym
- TFN-A
- Status last verified
- Feb 2025
- First submitted
- 14 Apr 2021
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will be kept confidential. Study findings and de-identified study data will be available to other researchers in the form of a published paper.
Publications
Kanis JA, Oden A, McCloskey EV, Johansson H, Wahl DA, Cooper C; IOF Working Group on Epidemiology and Quality of Life. A systematic review of hip fracture incidence and probability of fracture worldwide. Osteoporos Int. 2012 Sep;23(9):2239-56. doi: 10.1007/s00198-012-1964-3. Epub 2012 Mar 15.
PubMed 22419370Zickel RE. A new fixation device for subtrochanteric fractures of the femur: a preliminary report. Clin Orthop Relat Res. 1967 Sep-Oct;54:115-23. No abstract available.
PubMed 5589594Stapert JW, Geesing CL, Jacobs PB, de Wit RJ, Vierhout PA. First experience and complications with the long Gamma nail. J Trauma. 1993 Mar;34(3):394-400. doi: 10.1097/00005373-199303000-00015.
PubMed 8483181Lecerf G, Fessy MH, Philippot R, Massin P, Giraud F, Flecher X, Girard J, Mertl P, Marchetti E, Stindel E. Femoral offset: anatomical concept, definition, assessment, implications for preoperative templating and hip arthroplasty. Orthop Traumatol Surg Res. 2009 May;95(3):210-9. doi: 10.1016/j.otsr.2009.03.010. Epub 2009 May 6.
PubMed 19423418Paul O, Barker JU, Lane JM, Helfet DL, Lorich DG. Functional and radiographic outcomes of intertrochanteric hip fractures treated with calcar reduction, compression, and trochanteric entry nailing. J Orthop Trauma. 2012 Mar;26(3):148-54. doi: 10.1097/BOT.0b013e31821e3f8c.
PubMed 21918483Yoo JH, Kim TY, Chang JD, Kwak YH, Kwon YS. Factors influencing functional outcomes in united intertrochanteric hip fractures: a negative effect of lag screw sliding. Orthopedics. 2014 Dec;37(12):e1101-7. doi: 10.3928/01477447-20141124-58.
PubMed 25437085Gausden EB, Sin D, Levack AE, Wessel LE, Moloney G, Lane JM, Lorich DG. Gait Analysis After Intertrochanteric Hip Fracture: Does Shortening Result in Gait Impairment? J Orthop Trauma. 2018 Nov;32(11):554-558. doi: 10.1097/BOT.0000000000001283.
PubMed 30239477Bishop JA, Palanca AA, Bellino MJ, Lowenberg DW. Assessment of compromised fracture healing. J Am Acad Orthop Surg. 2012 May;20(5):273-82. doi: 10.5435/JAAOS-20-05-273.
PubMed 22553099
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Static Helical Screw Locking of Pertrochanteric Femur Fractures Using the TFN-Advanced Proximal Femoral Nailing System - a Randomized Trial
- ClinicalTrials.gov ID
- NCT04851509
- Acronym / sponsor ID
- TFN-A / FHREB#: 2021-015
- Conditions
- Pertrochanteric Fracture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- Fraser Orthopaedic Research SocietyResearch network
- Collaborators
- DePuy Synthes
- Study start
- 17 May 2021 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 20 Apr 2021 (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 study will investigate the shortening and collapse of pertrochanteric fractures following surgical management with the TFN-Advanced nailing system. The focus will be on comparing radiographic assessments of nails which have been statically locked versus dynamically locked. This is a randomized control study with the initial invention being randomized to either statically locking or dynamically locking. For a two-month period, all eligible patients will receive the randomized allocated treatment, then treatment will switch to the alternate treatment for the next two months and will continue to alternate treatments for two-month periods until study enrollment has completed.
Detailed description
Hip fractures are common injuries in the elderly population that result in significant morbidity and mortality and a significant burden on health care systems. Hip fractures can be treated with arthroplasty or with internal fixation, depending on the fracture pattern. Cephalomedullary nailing (CMN) has become one of the established treatments for intertrochanteric hip fractures with a wide variety of implant designs from many different companies. The TFN-ADVANCED™ Proximal femoral nailing system (TFN-A) is a novel implant for treating intertrochanteric and subtrochanteric proximal femur fractures with a paucity of published literature on the performance of this implant.
A method to decrease the amount of fracture compression is to use the set screw to lock the screw "statically" so it does not slide to the same degree as if the screw is placed in the "dynamic" or sliding position. To the knowledge of the investigators, the role of statically locking the screw to prevent fracture collapse has not been studied. Statically locking CMN to treat hip fractures has become standard of care at the Royal Columbian Hospital with all the investigating surgeons having adopted this practice in an attempt to prevent significant fracture collapse and neck shortening. Anecdotally, the investigators have not seen significant rates of cephalic screw cut-out over the past five years, and believe the investigators' screw cut-out rates are lower than what is reported in the literature. The investigators have been using the Gamma Nail (Stryker) to statically lock the screw as the previous TFN lacked the ability for static locking. However, with the advent of the TFN-A, the investigators have adopted this implant as their long cephalomedullary nail of choice for fixation of pertrochanteric femur fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized trial design utilizing alternating treatment allocation to assign patients to treatment arms, treatment allocations will last for two months at a time.
| Arm | Type | Receives |
|---|---|---|
| Dynamic rotational locking | Active comparator | Procedure: Dynamic Rotational LockingUsing a fracture table, the affected leg will be placed into traction and the patient will be prepped and draped in the usual fashion. The fracture will be provisionally reduced using closed techniques. A 3cm incision will be used to gain access to the intramedullary canal and the nail (either a short nail or long nail, at the discretion of the treating surgeon) will be introduced to the femur. The screw will be placed across the fracture and into the femoral head, aiming for a tip-to-apex distance less than 25mm. The compression nut will be used to compress the fracture. The screw will be rotationally locked by using the 5mm hex flexible screwdriver by advancing the set screw until it stops completely. The screw will then be turned counterclockwise by a ½ turn. |
| Static locking | Experimental | Procedure: Static LockingUsing a fracture table, the affected leg will be placed into traction and the patient will be prepped and draped in the usual fashion. The fracture will be provisionally reduced using closed techniques. A 3cm incision will be used to gain access to the intramedullary canal and the nail (either a short nail or long nail, at the discretion of the treating surgeon) will be introduced to the femur. The screw will be placed across the fracture and into the femoral head, aiming for a tip-to-apex distance of less than 25mm. The compression nut will be used to compress the fracture. The screw will then be statically locked using the 6Nm torque-limiting blue handle with 6mm hex coupling to completely lock the set screw down on the helical screw. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients >18 years of age
- AO/OTA 31-A fractures who the surgeon deems eligible for treatment with a cephalomedullary nail
- Open and closed fractures
- Ambulatory prior to injury (with or without walking aides)
- Native (non-fractured, no implant) contralateral hip
Key exclusion criteria (13 listed)
- Contralateral hip fracture or hip arthroplasty
- Fracture not amenable to treatment with a cephalomedullary nail
- Non-ambulatory patient
- Fractures >14 days (time of injury to OR)
- Bilateral pertrochanteric hip fractures
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 |
|---|---|---|
| Dynamic Rotational LockingPerformed, as per the Synthes technique guide, using the 5mm hex flexible set screwdriver and then loosening the set screw by one-half turn of the screwdriver. | Procedure or surgery | Dynamic rotational locking |
| Static LockingPerformed by using the torque-limiting set screwdriver and locking the set screw down onto the helical screw to prevent dynamic sliding of the screw within the nail. | Procedure or surgery | Static locking |
Primary outcome
Radiographic Assessment
Time frame: 12 months post treatment
The primary objective of this study will be to investigate how statically locking the TFN-A influences shortening or collapse of pertrochanteric fractures by measuring radiographic shortening or collapse of pertrochanteric fractures treated with the TFN-A implant.
4 secondary outcomes
Fracture Reduction Quality
Time frame: Intra-operatively
Femoral Offset
Time frame: 1 day post-op, 6 weeks, 12 weeks, 6 months, and 12 months
Tip-Apex distance
Time frame: 1 day post-op, 6 weeks, 12 weeks, 6 months, and 12 months
Complications
Time frame: intra-operatively, 1 day post-op, 6 weeks, 12 weeks, 6 months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Background: PubMed 22419370Kanis JA, Oden A, McCloskey EV, Johansson H, Wahl DA, Cooper C; IOF Working Group on Epidemiology and Quality of Life. A systematic review of hip fracture incidence and probability of fracture worldwide. Osteoporos Int. 2012 Sep;23(9):2239-56. doi: 10.1007/s00198-012-1964-3. Epub 2012 Mar 15.
- Background: PubMed 5589594Zickel RE. A new fixation device for subtrochanteric fractures of the femur: a preliminary report. Clin Orthop Relat Res. 1967 Sep-Oct;54:115-23. No abstract available.
- Background: PubMed 8483181Stapert JW, Geesing CL, Jacobs PB, de Wit RJ, Vierhout PA. First experience and complications with the long Gamma nail. J Trauma. 1993 Mar;34(3):394-400. doi: 10.1097/00005373-199303000-00015.
- Background: PubMed 19423418Lecerf G, Fessy MH, Philippot R, Massin P, Giraud F, Flecher X, Girard J, Mertl P, Marchetti E, Stindel E. Femoral offset: anatomical concept, definition, assessment, implications for preoperative templating and hip arthroplasty. Orthop Traumatol Surg Res. 2009 May;95(3):210-9. doi: 10.1016/j.otsr.2009.03.010. Epub 2009 May 6.
- Background: PubMed 21918483Paul O, Barker JU, Lane JM, Helfet DL, Lorich DG. Functional and radiographic outcomes of intertrochanteric hip fractures treated with calcar reduction, compression, and trochanteric entry nailing. J Orthop Trauma. 2012 Mar;26(3):148-54. doi: 10.1097/BOT.0b013e31821e3f8c.
- Background: PubMed 25437085Yoo JH, Kim TY, Chang JD, Kwak YH, Kwon YS. Factors influencing functional outcomes in united intertrochanteric hip fractures: a negative effect of lag screw sliding. Orthopedics. 2014 Dec;37(12):e1101-7. doi: 10.3928/01477447-20141124-58.
- Background: PubMed 30239477Gausden EB, Sin D, Levack AE, Wessel LE, Moloney G, Lane JM, Lorich DG. Gait Analysis After Intertrochanteric Hip Fracture: Does Shortening Result in Gait Impairment? J Orthop Trauma. 2018 Nov;32(11):554-558. doi: 10.1097/BOT.0000000000001283.
- Background: PubMed 22553099Bishop JA, Palanca AA, Bellino MJ, Lowenberg DW. Assessment of compromised fracture healing. J Am Acad Orthop Surg. 2012 May;20(5):273-82. doi: 10.5435/JAAOS-20-05-273.
- Individual participant dataSharing planned: No. Participant data will be kept confidential. Study findings and de-identified study data will be available to other researchers in the form of a published paper.
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.
Bertrand Perey, MD, FRCSC principal investigator
Royal Columbian Hospital/Fraser Health Authority
David Cinats, MD principal investigator
Orthopaedic Surgeon, Fraser Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Rotational Locking and Static Locking in people with Pertrochanteric Fracture, run by Fraser Orthopaedic Research Society at 1 site in Canada.
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 6 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 28 Feb 2025. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kyrsten Butterfield, BSc (604-553-3247, kyrsten.butterfield@fraserhealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Assessment (time frame: 12 months post treatment). 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 NCT04851509, which also lists 8 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 28 Feb 2025.