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

Trial Summary

What is the purpose of this 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.

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 data supports the effectiveness of the treatment Dynamic Rotational Locking, Dynamic Rotational Locking, Dynamic Locking, Static Locking, Static Helical Screw Locking, TFN-A Static Locking for hip fracture?

Research shows that the Trochanteric Fixation Nail (TFN) with a helical blade, which is similar to some of the techniques mentioned, has promising results in treating hip fractures. It has been found to improve stability and reduce complications compared to other methods, suggesting that these techniques could be effective for hip fractures. ^{1 2 3 4 5}

Is the screw locking technique for hip fracture generally safe for humans?

The Trochanteric Fixation Nail (TFN) with a helical blade, used in similar procedures, shows promising safety results with a lower complication rate compared to other methods. However, some complications like nonunion (failure to heal) and avascular necrosis (bone tissue death due to lack of blood supply) have been observed, indicating the need for further studies to confirm safety. ^{1 2 4 5 6}

How is the Dynamic Rotational Locking treatment for hip fractures different from other treatments?

Dynamic Rotational Locking is unique because it uses a helical blade design to improve stability and prevent rotation of the bone, which can help reduce complications like cutout (when the screw or blade moves out of place). This approach is different from traditional methods like the dynamic hip screw, which may not offer the same level of rotational stability. ^{1 2 6 7 8}

Research Team

David Cinats, MD

Principal Investigator

Orthopaedic Surgeon, Fraser Health Authority

Bertrand Perey, MD, FRCSC

Principal Investigator

Royal Columbian Hospital/Fraser Health Authority

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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 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]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Trochanteric Fixation Nail® with Helical Blade Compared with Femoral Neck Screw for Operative Treatment of Intertrochanteric Femoral Fractures. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Mechanical complications of intertrochanteric hip fractures treated with trochanteric femoral nails. [2022]

3. India pubmed.ncbi.nlm.nih.gov

Screw versus helical proximal femoral nail in the treatment of unstable trochanteric fractures in the elderly. [2022]

4. England 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. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

First clinical and biomechanical results of the Trochanteric Fixation Nail (TFN). [2013]

6. Switzerland 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). [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Prevention of rotation of the femoral head during internal fixation of subcapital fractures. [2019]

8. Italy 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. [2019]