NCT04441723

Brief Summary

The objective of this study is to compare the failure rate between two modes of fixing the lag screw of the cephalomedullary nail. The sample studied will be patients who have been diagnosed with a fragility intertrochanteric fracture. Investigators hypothesis is that the dynamic mode will have a lower failure rate compared to the static mode.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

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

January 11, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 22, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

June 24, 2020

Status Verified

June 1, 2020

Enrollment Period

1.1 years

First QC Date

June 18, 2020

Last Update Submit

June 22, 2020

Conditions

Hip Fractures

Keywords

Hip fracturesIntertrochanteric fracturesCephalomedullary NailsCut-outCut through

Outcome Measures

Primary Outcomes (1)

  • Implant failure

    Rate of cut out , cut through.

    6 months

Secondary Outcomes (2)

  • Complications

    3 weeks, 3 months , 6 months

  • Offset

    6 months

Study Arms (2)

lag screw with dynamic mode

ACTIVE COMPARATOR

Device: Gamma 3 nail whit lag screw on dynamic mode Surgical stabilization of intertrochanteric hip fractures using two different lag screw modes

Device: Osteosynthesis with Gamma 3 nail , using a dynamic lag screw as a proximal fixation.

lag screw with static mode

ACTIVE COMPARATOR

Device: Gamma 3 nail whit lag screw on dynamic mode Surgical stabilization of intertrochanteric hip fractures using two different lag screw modes

Device: Osteosynthesis with Gamma 3 nail , using a static lag screw as a proximal fixation.

Interventions

Osteosynthesis with Gamma 3 nail , using a dynamic lag screw as a proximal fixation.DEVICE

Closed reduction and surgical stabilization of intertrochanteric hip fractures using Gamma 3 nail , with dynamic lag screw as proximal fixation

lag screw with dynamic mode
Osteosynthesis with Gamma 3 nail , using a static lag screw as a proximal fixation.DEVICE

Closed reduction and surgical stabilization of intertrochanteric hip fractures using Gamma 3 nail , with static lag screw as proximal fixation

lag screw with static mode

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older 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:

  • A fracture due to malignancy
  • Previous contralateral fracture
  • Inability to walk before the fracture
  • An inability to comply with rehabilitation
  • Follow-up of less than 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Traumatologico

Santiago, Chile

RECRUITING

Related Publications (3)

  • Kuzyk PR, Shah S, Zdero R, Olsen M, Waddell JP, Schemitsch EH. A biomechanical comparison of static versus dynamic lag screw modes for cephalomedullary nails used to fix unstable peritrochanteric fractures. J Trauma Acute Care Surg. 2012 Feb;72(2):E65-70. doi: 10.1097/ta.0b013e3182170823.

    PMID: 22439235BACKGROUND

  • Mahomed N, Harrington I, Kellam J, Maistrelli G, Hearn T, Vroemen J. Biomechanical analysis of the Gamma nail and sliding hip screw. Clin Orthop Relat Res. 1994 Jul;(304):280-8.

    PMID: 8020229BACKGROUND

  • Bhandari M, Swiontkowski M. Management of Acute Hip Fracture. N Engl J Med. 2017 Nov 23;377(21):2053-2062. doi: 10.1056/NEJMcp1611090. No abstract available.

    PMID: 29166235BACKGROUND

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

Pablo Suarez, MD

CONTACT

+56961572181pablosuarez088@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2020

First Posted

June 22, 2020

Study Start

January 11, 2020

Primary Completion

February 1, 2021

Study Completion

July 30, 2021

Last Updated

June 24, 2020

Record last verified: 2020-06

Locations

CL(1)