Static Locking for Pertrochanteric Fractures

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Royal Columbian Hospital/Fraser Health Authority, New Westminster, Canada
Pertrochanteric Fractures+2 More
Static Locking - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether a new type of nail can shorten and collapse fractures more effectively than the standard type of nail.

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Eligible Conditions

  • Pertrochanteric Fractures

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Static Locking will improve 1 primary outcome and 8 secondary outcomes in patients with Pertrochanteric Fractures. Measurement will happen over the course of intra-operatively, 1 day post-op, 6 weeks, 12 weeks, 6 months, and 12 months.

Month 12
Femoral Offset
Tip-Apex distance
12 months post treatment
Radiographic Assessment
Month 12
Harris Hip Score (HHS)
Month 12
SF-12
Timed Up & Go (TUG)
Visual analog scale (VAS)
Intra-operatively
Fracture Reduction Quality
Month 12
Complications

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Dynamic rotational locking
1 of 2
Static locking
1 of 2
Active Control
Experimental Treatment

This trial requires 218 total participants across 2 different treatment groups

This trial involves 2 different treatments. Static Locking is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Static locking
Procedure
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 helical 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 helical 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.
Dynamic rotational locking
Procedure
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 helical 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 helical 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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 weeks, 12 weeks, 6 months, 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 weeks, 12 weeks, 6 months, 12 months for reporting.

Closest Location

Royal Columbian Hospital/Fraser Health Authority - New Westminster, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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)
Able and willing to answer patient-reported outcome questionnaires and attend standard-of-care clinical visits

Patient Q&A Section

What are the signs of femoral fractures?

"Pain in the thigh, leg and groin is the most common presenting complaint and is suggestive of a femoral fracture. The ability to bear weight on one leg is suggestive of a hip fracture. Pneumothorax is a rare complication that usually occurs within the first week of admission." - Anonymous Online Contributor

Unverified Answer

How many people get femoral fractures a year in the United States?

"An estimated 19,700 femoral fractures occur annually in the United States. The fracture occurs mostly in men 65 and older. Most of these injuries can be traced back to falls or blunt trauma, specifically sports injury." - Anonymous Online Contributor

Unverified Answer

Can femoral fractures be cured?

"A fracture of the femur by a trauma patient should always be treated with open reduction and internal fixation as soon as possible, since in many other respects the patients are good candidates to surgical treatment. But if any doubt about the fracture can be excluded, a closed reduction and percutaneous pinning procedure may be undertaken." - Anonymous Online Contributor

Unverified Answer

What is femoral fractures?

"When an injury is classified as a type A3, X or G it is a femoral shaft fracture. This can be suspected in the absence of any other signs of injury." - Anonymous Online Contributor

Unverified Answer

What causes femoral fractures?

"Over time, we identified several significant risk factors for fracture; however, many factors probably have a small effect, so these factors need to be investigated in finer detail to be useful in risk assessment. We found strong support for a major osteosclerosis factor. As the osteosclerosis is a non-modifiable risk factor, targeting it with treatment could improve the prevention of fractures at this site in older people." - Anonymous Online Contributor

Unverified Answer

What are common treatments for femoral fractures?

"For most femur fractures, nonoperative management is preferred, with conservative care or short-time immobilization being the most popular treatment. Surgery is sometimes utilized, especially for open fractures or fractures involving the neck of the femur or around intertrochanteric joints." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of static locking?

"In our experience, static locking is associated with a high rate of wound infection, compartment syndrome, vascular injury, nerve injuries, and knee arthritis. Especially with the latter, early and aggressive treatment is required to avoid serious complications." - Anonymous Online Contributor

Unverified Answer

Is static locking typically used in combination with any other treatments?

"The data for this study have confirmed a [contribution of static locking] to decrease risk of knee dislocation with a high rate of pain resolution during short immobilization after surgery. For our purposes, this study confirms its use is to prevent knee dislocation when combined with other treatments. We would consider its use of static locking when combined with other treatments (internal fixation and/or physiologic treatments (e.g. Kinemax) to treat a femoral fracture." - Anonymous Online Contributor

Unverified Answer

How does static locking work?

"Static locking screws with diameters outside 3 mm of the ideal size provided better fixation than those without screw widening. With an implant thickness of 4.5 mm, the static locking screws with diameters between 2 and 5 mm provided better fixation than the larger diameter static locking screws. In addition, static locking screws with diameters greater than 5 mm provided better fixation than those with 2 mm diameters. However, the static locking systems with larger diameters worked less well than their larger diameters. Based on the above results, 3." - Anonymous Online Contributor

Unverified Answer

Has static locking proven to be more effective than a placebo?

"Using mechanical compression, static locking does not decrease in-hospital length of stay when applied to non-osteoporotic patients with femoral fractures. The use of compression stockings should not be encouraged to simplify the treatment of non-osteoporotic femoral fractures." - Anonymous Online Contributor

Unverified Answer

How serious can femoral fractures be?

"Femoral fractures commonly require operative treatment; however, the high rates of mortality and morbidity suggest that patient and physician education may be enhanced by the use of clinical prediction rules." - Anonymous Online Contributor

Unverified Answer

Does static locking improve quality of life for those with femoral fractures?

"For those with femoral fractures, a locked plating resulted in higher levels of pain in the knee when compared with open plating. These differences were not seen for those without fractures or with only minor fractures. Although there is no evidence to support the routine use of locked plates, in patients with femoral fractures, our results provide strong support for the use of a locking plate to improve recovery." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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