NCT00736684

Brief Summary

The purpose of this study is to compare rates of any fracture fixation complication and revision rates after intramedullary fixation of unstable trochanteric fractures between the Proximal Femoral Nail Antirotation™ (PFNA)(Investigational Group) and Gamma Nail 3™ (Gamma3) (Control Group).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
440

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2007

Typical duration for phase_4

Geographic Reach
1 country

6 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 18, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

February 11, 2011

Status Verified

February 1, 2011

Enrollment Period

1.8 years

First QC Date

August 15, 2008

Last Update Submit

February 10, 2011

Conditions

Unstable Trochanteric Fractures

Keywords

Femoral fractures [MeSH]hip fractures [MeSH]trochanteric fractures (femoral neck fractures [MeSH])intramedullary nailing (fracture fixation, intramedullary [MeSH])complex femoral fracturesfemoral nailsurgical treatment (surgical procedures, operative [MeSH])complications

Outcome Measures

Primary Outcomes (1)

  • Any fracture fixation complication.

    One year

Secondary Outcomes (1)

  • Bone union/fusion as evaluated by CT-scanning, health-related quality of life, disease-specific functional scoring, activities of daily living, mortality, radiological parameters, surgery details and surgeons' evaluation of handling and effectiveness.

    One year

Study Arms (2)

1

ACTIVE COMPARATOR

Proximal Femoral Nail AntirotationTM (PFNA)

Device: Proximal Femoral Nail AntirotationTM (PFNA)

2

OTHER

Gamma Nail 3TM (Gamma3)

Device: Gamma Nail 3TM (Gamma3)

Interventions

Proximal Femoral Nail AntirotationTM (PFNA)DEVICE

intramedullary nailing

1
Gamma Nail 3TM (Gamma3)DEVICE

intramedullary nailing

2

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 55 years and more
  • Patients with isolated, unstable, closed or type 1 open trochanteric fractures, classified as AO 31-A2 or AO 31-A3
  • Definitive primary fracture treatment with PFNA or Gamma3 (defined inTable 1) within three days after the index event
  • Signed written informed consent (by the subjects or legal guardian) and agreement to attend the planned follow-ups

You may not qualify if:

  • Pathologic fracture of any other cause than osteoporosis
  • Patients or legal guardian refusing to sign the informed consent form
  • Multiple trauma
  • Type 2 and 3 open fractures
  • Drug or alcohol abuse
  • Wound and/or bone healing disorders of any other cause than diabetes mellitus or smoking
  • Active malignancy
  • Expected life expectancy ≤ 3 months
  • Neurological and psychiatric disorders that would preclude reliable assessment (eg,, Parkinson disease, Multiple sclerosis, severe depression)
  • Rheumatoid arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hospital Universitario "Marqués de Valdecilla"

Santander, Cantabria, 39008, Spain

Location

Hospital Clinic

Barcelona, Catalonia, 08036, Spain

Location

Hospital Gregorio Marañon

Madrid, Madrid, 28007, Spain

Location

Hospital Puerta de Hierro

Madrid, Madrid, 28035, Spain

Location

H.U. Virgen de la Arrixaca

Murcia, 30071, Spain

Location

Hospital Donostia

San Sebastián, 20014, Spain

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Beate P. Hanson, MD

    AO Clinical Investigation and Documentation, Davos, Switzerland

    STUDY DIRECTOR

  • Javier Vaquero Martin, MD

    Hospital Gregorio Marañon, Madrid, Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 15, 2008

First Posted

August 18, 2008

Study Start

November 1, 2007

Primary Completion

September 1, 2009

Study Completion

September 1, 2010

Last Updated

February 11, 2011

Record last verified: 2011-02

Locations

ES(6)