Screw Locking Techniques for Hip Fracture

(TFN-A Trial)

Overseen By Kyrsten Butterfield, BSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Fraser Orthopaedic Research Society

Disqualifiers: Contralateral hip fracture, Non-ambulatory, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 2 months per treatment type, alternating

218 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to fix hip fractures using a special nailing system. It compares two methods: Static Locking, where the screw is locked in place, and Dynamic Rotational Locking, where the screw has some room to move. The goal is to determine which method aids better bone healing. Individuals with a specific type of hip fracture who could walk before their injury might be suitable for this study. As an unphased trial, participants can contribute to advancing medical knowledge and potentially benefit from innovative treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these screw locking techniques are safe for hip fracture treatment?

Research has shown that treatments using dynamic rotational and static locking techniques for hip fractures are generally safe. Studies on dynamic locking methods indicate they often lead to fewer complications during fracture healing, allowing patients to recover with fewer issues.

For static locking, research suggests it is a safe method that does not interfere with bone healing. In fact, some hospitals use static locking as a standard treatment, indicating doctors trust its safety and effectiveness.

Both methods appear well-tolerated based on current data, with no major safety concerns reported in past trials. However, like any medical procedure, risks exist, so participants should discuss these with their healthcare providers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these screw-locking techniques for hip fractures because they aim to enhance stability and healing. Unlike traditional static locking, which firmly locks the screw in place, dynamic rotational locking allows for controlled micro-movements, potentially improving fracture healing by stimulating bone growth. Both methods focus on achieving precise placement of the screw with a tip-to-apex distance of less than 25mm, but dynamic rotational locking might offer the added benefit of flexibility during the healing process. By comparing these two approaches, researchers hope to determine which method provides better outcomes for patients with hip fractures.

What evidence suggests that these screw locking techniques are effective for hip fractures?

This trial will compare dynamic rotational locking with static locking for treating hip fractures. Research has shown that dynamic rotational locking systems, one of the methods under study, can effectively treat hip fractures. Studies have found that these systems often result in less surgical damage, shorter surgery times, and better healing compared to some other methods. Static locking, another method tested in this trial, stabilizes fractures well, but there remains a risk of the bone shortening after surgery. Both methods aim to help fractures heal and maintain bone alignment, but dynamic systems might lead to quicker recovery and better overall results. ^{3 6 7 8 9}

Who Is on the Research Team?

David Cinats, MD

Principal Investigator

Orthopaedic Surgeon, Fraser Health Authority

Bertrand Perey, MD, FRCSC

Principal Investigator

Royal Columbian Hospital/Fraser Health Authority

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a specific type of hip fracture (AO/OTA 31-A) who were able to walk before their injury, even if they needed help. They must have a healthy other hip, be able to give consent, fill out questionnaires, and come to follow-up visits. People can't join if they're unlikely to follow up, have fractures around hip replacements or on both sides, non-healing bones, are bedridden or have dementia.

Inclusion Criteria

I have a broken bone, whether the skin is broken or not.

I am older than 18 years.

My surgeon recommends a specific type of nail for my leg fracture.

Exclusion Criteria

I have had a hip fracture or hip replacement on the opposite side.

My fracture cannot be treated with a specific type of internal fixation.

I cannot walk by myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either statically or dynamically locked TFN-A treatment for pertrochanteric femur fractures, alternating every two months

2 months per treatment type, alternating

Follow-up

Participants are monitored for safety and effectiveness after treatment, with radiographic assessments and measurement of femoral offset and complications

12 months

1 day post-op, 6 weeks, 12 weeks, 6 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Dynamic Rotational Locking
• Static Locking

Trial Overview The study tests two ways of fixing broken hips using the TFN-Advanced nailing system: 'static locking' keeps the nail fixed in place while 'dynamic rotational locking' allows some movement. Patients will randomly get one method for two months before switching to the other; this cycle repeats until everyone's enrolled.

How Is the Trial Designed?

Group I: Static locking Experimental Treatment 1 Intervention

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.

Group II: Dynamic rotational locking Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Fraser Orthopaedic Research Society

Lead Sponsor

Trials

10

Recruited

940+

DePuy Synthes

Industry Sponsor

Trials

33

Recruited

4,900+

Published Research Related to This Trial

In a study of 152 patients with intertrochanteric hip fractures, those treated with the trochanteric fixation nail advance (TFNA) showed significantly better outcomes, achieving full weight-bearing at discharge more effectively than those treated with the dynamic hip screw (DHS).

The TFNA group had a higher incidence of unstable fractures, yet still outperformed the DHS group, which also had higher mortality rates likely linked to longer delays in surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Morbidity and Mortality Analysis in the Treatment of Intertrochanteric Hip Fracture with Two Fixation Systems: Dynamic Hip Screw (DHS) or Trochanteric Fixation Nail Advance (TFNA). López-Hualda, A., Arruti-Pérez, E., Bebea-Zamorano, FN., et al.[2023]

In a study of 320 patients with hip fractures treated with a dynamic locking plate, the overall complication rates were relatively low, with only 2.7% of undisplaced fractures developing nonunion and 15.4% of displaced fractures experiencing similar issues.

The findings suggest that the Targon Femoral Neck plate may offer better stability and lower complication rates compared to other fixation devices, although further research is needed to confirm these advantages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internal fixation of intracapsular fractures of the hip using a dynamic locking plate: Two-year follow-up of 320 patients. Parker, M., Cawley, S., Palial, V.[2022]

The trochanteric fixation nail (TFN) demonstrated a significantly lower overall complication rate in a clinical study of 145 patients compared to traditional osteosynthesis methods for proximal femur fractures, suggesting improved safety and efficacy.

Biomechanical analyses showed that the TFN blade has favorable load-bearing characteristics, indicating enhanced stability and performance under various loading conditions, which may address the common issue of implant failure due to bone quality deterioration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First clinical and biomechanical results of the Trochanteric Fixation Nail (TFN). Lenich, A., Fierlbeck, J., Al-Munajjed, A., et al.[2013]

In a study of 60 patients with unstable trochanteric fractures, both screw proximal femoral nail (PFN) and helical PFN were found to be equally effective for internal fixation, with no significant differences in clinical outcomes.

However, the helical PFN group had a significantly shorter mean surgery duration and less blood loss compared to the screw PFN group, suggesting it may be a more efficient option for this type of fracture management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screw versus helical proximal femoral nail in the treatment of unstable trochanteric fractures in the elderly. Kumar, CN., Srivastava, MPK.[2022]

A new technique has been developed to prevent the rotation of the femoral head during the fixation of subcapital fractures using an AO dynamic hip screw system.

This method aims to improve the stability and effectiveness of the surgical procedure, potentially leading to better patient outcomes in hip fracture management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of rotation of the femoral head during internal fixation of subcapital fractures. Villar, RN., Grover, ML., Thomas, WG.[2019]

In a study of 223 patients with intertrochanteric hip fractures treated using the Trochanteric Fixation Nail System (TFN), the overall rate of mechanical complications was 20.5%, with the most common issue being excessive lateral migration of the helical blade in 9.4% of cases.

The quality of calcar reduction was a significant predictor of failure modes, indicating that proper placement of the device can reduce complications, particularly when the blade is positioned inferiorly with a tip-apex distance of at least 15 mm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanical complications of intertrochanteric hip fractures treated with trochanteric femoral nails. Liu, W., Zhou, D., Liu, F., et al.[2022]

In a study of 150 patients with intertrochanteric femur fractures, the Proximal Femoral Nail Antirotation (PFNA) method showed superior clinical efficacy compared to the Proximal Femoral Locking Compression Plate (PF-LCP) and Dynamic Hip Screw (DHS) methods, with shorter surgical duration, less bleeding, faster callus formation, and quicker healing times.

The PFNA method also resulted in significantly higher Harris scores at 1, 3, and 6 months post-operation, indicating better recovery of hip joint function, while maintaining a lower complication rate compared to the other methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative study of proximal femoral locking compress plate, proximal femoral nail antirotation and dynamic hip screw in intertrochanteric fractures. Zang, W., Liu, PF., Han, XF.[2019]

In a study of 631 patients with intertrochanteric femoral fractures, the use of the Trochanteric Fixation Nail (TFN®) with a helical blade showed no significant difference in cut-out rates compared to the TFN® with a femoral neck screw, with both groups experiencing a low cut-out rate of 2.7%.

The results indicate that there are no significant differences in surgical outcomes between the two types of implants, suggesting that the choice of implant should not be based solely on the outcomes measured in this study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trochanteric Fixation Nail® with Helical Blade Compared with Femoral Neck Screw for Operative Treatment of Intertrochanteric Femoral Fractures. van Leur, JPH., Jakma, TSC., Willemsen, SP., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5669921/

Clinical outcome of dynamic hip locking plates and ... Proximal femoral nail anti-rotation (PFNA) and locking compression plate (LCP) have good effectiveness in the treatment of intertrochanteric fractures with the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9275283/

The efficacy of dynamic compression locking system vs. ... Compared with DHS, DCLS in the treatment of FNF had less surgical trauma, shorter incision length, shorter operation time, lower radiation dose and higher ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1743919118305235

Is dynamic locking plate(Targon FN) a better choice for ... The available evidence indicate that dynamic locking plate offers a superior outcome in comparison with alternative implants and reduces the nonunion, revision ...

4. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-020-3131-x

an RCT on the Dynamic Locking Blade Plate (DLBP) versus ... We hypothesize that the DLBP is superior compared to the DHS in terms of revision surgery rate, union rate, incidence of avascular necrosis and ...

5. frontiersin.org frontiersin.org/journals/surgery/articles/10.3389/fsurg.2025.1546873/full

Comparison of clinical efficacy between proximal femoral ... The PFLP group exhibited a markedly superior fracture healing time, femoral neck shortening, and Harris hip scores in comparison to the CCS group.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11599314/

The dynamic locking blade plate: seven-year follow-up ... This study aimed to investigate the long-term outcomes of patients with a femoral neck fracture (FNF), treated with the Dynamic Locking Blade Plate (DLBP).

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12309159/

Dynamic hip screw versus proximal femoral nailing in ... This review article aims to compare the efficacy and outcomes of DHS and PFN in the treatment of stable intertrochanteric fractures, focusing on ...

8. journals.lww.com journals.lww.com/md-journal/fulltext/2018/11210/is_dynamic_locking_plate_superior_than_other.7.aspx

Is dynamic locking plate superior than other implants for... Results showed that, compared with other implants, the complications related to the healing of the fracture are significantly decreased. However, whether ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2773157X24002303

Investigating hip muscles function in subtrochanteric ... The aim of this study was to compare the results of abductor muscles function in subtrochanteric fracture stabilized with dynamic condyle screw (DCS) versus ...