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Pertrochanteric Fracture of Femur, ClosedNCT03491189

Blade vs Screw Intertrochanteric Hip Fracture Fixation Study

A study testing Lag screw fixation and Helical blade fixation in people with Pertrochanteric Fracture of Femur, Closed, run by Milton S. Hershey Medical Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study evaluates the rate of cut-out and fixation failures in helical blade fixation versus lag screw fixation for cephalomedullary nailing of peritrochanteric femur fractures. Read more about this study

Who is it for?
Ages 55 years and older
What is being tested?
Lag screw fixation and Helical blade fixation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Apr 2018to 19 Jun 2018
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

  • patients presenting with low-energy peritrochanteric femur fractures
  • Age 55 years and older
  • Sex: male or female

Who cannot join

  • Non English speaking
  • Age < 55 years

About this study

Official title: Helical Blade vs Lag Screw Fixation for Intertrochanteric Hip Fractures: A Prospective Randomized Controlled Study

This study evaluates the rate of cut-out and fixation failures in helical blade fixation versus lag screw fixation for cephalomedullary nailing of peritrochanteric femur fractures.

Read the detailed description

As the population ages, the prevalence of peritrochanteric femur fractures continues to increase each year. An increase in the use of intramedullary devices as treatment has accompanied this increase in peritrochanteric femur fractures. Intramedullary devices are now used more frequently than plate and screw constructs nationwide to treat peritrochanteric femur fractures1. While the prognosis following intramedullary device placement remains favorable compared to other treatment options, there are still complications that exist. Cut-out of the cephalomedullary implant through the femoral head has long been one of the more prevalent complications when using an intramedullary device.2 To address the shortcomings that cause lag screw cut-out, the helical blade was designed. In theory, it provides improved fixation over the lag screw by compacting cancellous bone as it is inserted and may also be more effective at supporting torsional loading.3 Additionally, the helical blade has been shown to require less operation time and less fluoroscopy time during implantation.4

Currently, there is a lack of a randomized prospective study comparing the rates of cut-out in lag screw fixation and helical blade fixation of peritrochanteric femur fractures using third generation cephalomedullary femoral nails. A recent retrospective study by Stern et al analyzed the rate of cut-out of helical blades and lag screws in peritrochanteric femur fractures treated with cephalomedullary nails and found that the helical blade was much more prone to cut-out than the lag screw. Cut-out rates were 15.1% and 3.0% for the implants respectively.5 While this study seems to suggest that, in terms of cutout, the helical blade is inferior to the lag screw, there are many factors that limit its validity and applicability. First, the study was a retrospective study which inherently induces some level of bias. Next, the study recorded a cut-out rate for the helical blade that is much higher than and not consistent with studies that have been previously reported. Flores et al reported a cut-out rate of 3.4% in 258 patients treated with the helical blade, Gardner et al reported a cut-out rate of 5.15% in 97 patients treated with the helical blade, and Liu et al reported a cut-out rate of 6.7% in 223 patients treated with the helical blade.6,7,8 These numbers are all drastically lower than the rates of cut-out reported by Stern et al. Another limitation to their study was that 26 surgeons operated on the 362 patients that were included in the study. This large number of surgeons introduced a significant amount of variability that could not be controlled for. While this study provides some evidence that the helical blade may be inferior to the lag screw in terms of cut-out, it is not definitive and a prospective study is needed to truly validate this claim. Additionally, factors such as tip-apex distance, time to cut-out, direction of cut-out reduction quality, and fracture pattern must be analyzed to accurately assess the usefulness of the helical blade compared to the lag screw and determine predictors for cut-out.

While the primary purpose of this study will be to analyze rates of cut-out between the two fixation devices, we are also interested in determining a threshold tip-apex distance that is predictive of cut-out. While Stern et al reported data that supported the hypothesis that increased tip-apex distance is predictive of cut-out, they did not identify a threshold that, itself, is predictive of cut-out.5 It was previously thought that a tip-apex distance greater than 25mm is predictive of cut-out.4 Other studies, however, have shown that tip-apex distances that are too small are also predictive of cutout.8 It will be our goal to measure tip-apex distance in all patients and attempt to determine if there is a threshold that is predictive of cut-out.

Another factor of importance that we will investigate is the direction of cut-out of the two implants. Previous comparisons have found that while the lag screw tends to cutout superiorly, the helical blade is much more likely to cutout medially.5,8 This is thought to be due to the compaction of bone that occurs when the helical blade is inserted and also why there appears to be greater rates of cut-out with smaller tip-apex distances.8 By gaining a further understanding of the direction that these implants typically fail we hope to have another predictor of cut-out.

Finally, it will be our goal to attempt to assess reduction quality and fracture pattern to determine each factor's predictive value of cut-out. It has already been suggested that non-anatomical reduction and complex fracture patterns increase the likelihood of cut-out.9

Being tested
Lag screw fixation, Helical blade fixation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lag screw fixationDevice

    Also called Cephalomedullary Hip Screw

    surgical fixation

  • Helical blade fixationDevice

    Also called Cephalomedullary Blade

    surgical fixation

Study groups in NCT03491189
Study groupRoleWhat they receive
Lag screw fixationActive comparatorLag screw fixation
Receives: Device: Lag screw fixation
Helical Blade fixationActive comparatorHelical Blade fixation
Receives: Device: Helical blade fixation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Implant cut-out

    Rate of implant cut-out after cephalomedullary nailing of peritrochanteric femur fractures in a randomized prospective study.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2018
  2. Study startApr 2018 (estimated)
  3. Primary completion19 Jun 2018
  4. Study completion19 Jun 2018

Why it stopped: Protocol change

Resources

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03491189
Sponsor's protocol ID
00008033
Status last verified
Aug 2018
First submitted
29 Mar 2018
Last updated
4 Sep 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Lag screw fixation and Helical blade fixation in people with Pertrochanteric Fracture of Femur, Closed, run by Milton S. Hershey Medical Center.

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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 4 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Implant cut-out (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 4 Sep 2018; AzTrials last refreshed its copy on 30 Oct 2026.

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