NCT04306198

Brief Summary

The purpose of this study will be to compare the failure and complications rates of and orthopedic implant (Cephalomedullary Nail) fixed with two different options actually available: lag screw or helical blade. The study population will be patient who have been diagnosed with an intertrochanteric hip fracture. Hypothesis: Our hypothesis is that the helical blade will have a higher failure rate compared to the lag screw

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 12, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

March 12, 2020

Status Verified

March 1, 2020

Enrollment Period

1.1 years

First QC Date

March 4, 2020

Last Update Submit

March 10, 2020

Conditions

Hip Fractures

Keywords

Hip fracturesIntertrochanteric fracturesHelical bladeCut-out

Outcome Measures

Primary Outcomes (1)

  • Implant Failure

    Rate of cut out , cut through, varus collapse

    6 months

Secondary Outcomes (2)

  • Complications

    3 weeks, 3 months , 6 months

  • Parker Mobility score

    3 months , 6 months

Study Arms (2)

Lag Screw

ACTIVE COMPARATOR

Device: Trochanteric Fixation Nail (TFN) whit lag screw Surgical stabilization of intertrochanteric hip fractures using two different proximal fixation implants

Device: Osteosynthesis with Trochanteric Fixation Nail (TFN), using a lag screw as a proximal fixation.

Helical Blade

ACTIVE COMPARATOR

Device: Trochanteric Fixation Nail (TFN) whit helical blade Surgical stabilization of intertrochanteric hip fractures using two different proximal fixation implants

Device: Osteosynthesis with Trochanteric Fixation Nail (TFN), using a helical blade as a proximal fixation.

Interventions

Osteosynthesis with Trochanteric Fixation Nail (TFN), using a lag screw as a proximal fixation.DEVICE

Closed reduction and surgical stabilization of intertrochanteric hip fractures using Trochanteric Fixation Nail (TFN), with lag screw as proximal fixation

Lag Screw
Osteosynthesis with Trochanteric Fixation Nail (TFN), using a helical blade as a proximal fixation.DEVICE

Closed reduction and surgical stabilization of intertrochanteric hip fractures using Trochanteric Fixation Nail (TFN), with helical blade as proximal fixation

Helical Blade

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Low Energy Mechanism
  • Hip fracture classified as 31.A1.2 - 31 A1.3 and 31.A2 in the AO classification (year 2018)

You may not qualify if:

  • Medical contraindication to surgery
  • A fracture due to malignancy
  • Peri implant fractures
  • Inability to walk before the fracture
  • An inability to comply with rehabilitation
  • Non-ambulatory pre-fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Cooper C, Campion G, Melton LJ 3rd. Hip fractures in the elderly: a world-wide projection. Osteoporos Int. 1992 Nov;2(6):285-9. doi: 10.1007/BF01623184.

    PMID: 1421796RESULT

  • Sommers MB, Roth C, Hall H, Kam BC, Ehmke LW, Krieg JC, Madey SM, Bottlang M. A laboratory model to evaluate cutout resistance of implants for pertrochanteric fracture fixation. J Orthop Trauma. 2004 Jul;18(6):361-8. doi: 10.1097/00005131-200407000-00006.

    PMID: 15213501RESULT

  • Al-Munajjed AA, Hammer J, Mayr E, Nerlich M, Lenich A. Biomechanical characterisation of osteosyntheses for proximal femur fractures: helical blade versus screw. Stud Health Technol Inform. 2008;133:1-10.

    PMID: 18376008RESULT

  • Ibrahim I, Appleton PT, Wixted JJ, DeAngelis JP, Rodriguez EK. Implant cut-out following cephalomedullary nailing of intertrochanteric femur fractures: Are helical blades to blame? Injury. 2019 Apr;50(4):926-930. doi: 10.1016/j.injury.2019.02.015. Epub 2019 Feb 20.

    PMID: 30885393RESULT

MeSH Terms

Conditions

Hip Fractures

Interventions

Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Central Study Contacts

Tomas Amenabar, MD

CONTACT

+56991594716tomasamenabar@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Tomas Amenabar Vial , Head of hip and pelvis department.

Study Record Dates

First Submitted

March 4, 2020

First Posted

March 12, 2020

Study Start

March 1, 2020

Primary Completion

April 1, 2021

Study Completion

November 1, 2021

Last Updated

March 12, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share