NCT01238068

Brief Summary

The study hypothesis is the the results of the use of Gamma nail will be superior to the use of Dynamic hip screw for unstable intertrochantric hip fracture.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2010

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

First Submitted

Initial submission to the registry

October 26, 2010

Completed
6 days until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 10, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

November 10, 2010

Status Verified

October 1, 2010

Enrollment Period

1 year

First QC Date

October 26, 2010

Last Update Submit

November 9, 2010

Conditions

Intertrochanteric Fractures of the Hip

Outcome Measures

Primary Outcomes (1)

  • hip function score

    at the last clinical visit (1 year) the patient will perform hip score testing and record.

    1 year

Secondary Outcomes (1)

  • x-ray, surgical outcome

    1 year

Study Arms (1)

Gamma nail, fracture stabilization, better walking

ACTIVE COMPARATOR
Device: gamma nail stryker

Interventions

gamma nail strykerDEVICE

for acute unstable pertrochantric fractures the subjects will be treated randomaly with either Gamma nail device Vs Dynamic hip screw

Gamma nail, fracture stabilization, better walking

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients diagozied with acute intertrochantric unstable fracture
  • a minimum minimental score of 6
  • ability to walk 500 meters indepedently

You may not qualify if:

  • pathological fracture
  • multiple fractures
  • neurological conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Medical center

Tel Aviv, Israel

Location

Related Publications (1)

  • Lewis SR, Macey R, Gill JR, Parker MJ, Griffin XL. Cephalomedullary nails versus extramedullary implants for extracapsular hip fractures in older adults. Cochrane Database Syst Rev. 2022 Jan 26;1(1):CD000093. doi: 10.1002/14651858.CD000093.pub6.

    PMID: 35080771DERIVED

Central Study Contacts

ortal segal, MD

CONTACT

972-52-60172ortal_San@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

October 26, 2010

First Posted

November 10, 2010

Study Start

November 1, 2010

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

November 10, 2010

Record last verified: 2010-10

Locations

IL(1)