Comparison of Gamma Nail Versus Dynamic Hip Screw for the... | NCT01173744

Studies
Comparison of Gamma Nail Versus Dynamic Hip Screw for the Treatment of Unstable Intertrochanteric Fractures

NCT01173744

Sponsor

Wolfson Medical Center

Status

Unknown status

Last Update Posted

Jun 17, 2011Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Intertrochanteric Femoral Fractures

Interventions

Gamma-3 Nail
DHS

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Jul 2012Estimated

Completion Date

Jul 2012Estimated

First Submitted Date

Jul 27, 2010

First Submission Date that Met QC Criteria

Jul 29, 2010

First Posted Date

Aug 2, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2011

Last Update Posted Date

Jun 17, 2011Estimated

Description Module

Brief Summary

The objective of the study is to examine the treatment of unstable Intertrochanteric fractures with the short Gamma nail, compared to the use of the dynamic hip screw (DHS).

This is a prospective study. Sixty patients with unstable Intertrochanteric fractures will be randomized to be treated using either Gamma nail or DHS. The patients will be followed for 12 months. The primary endpoint is the clinical outcome as measured by the Merle d'Aubigne and Postelhip score.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gamma-3 Nail	Experimental		Device: Gamma-3 Nail
DHS	Active Comparator		Device: DHS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gamma-3 Nail	Device	Gamma-3 Nail (stryker)	Gamma-3 Nail
DHS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical outcome as measured by the Merle d'Aubigne and Postel hip score		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Acute Intertrochanteric fracture - A1-32 AO/OTA
Abbreviated mental score >6
Community ambulator (pre-fracture state)

Exclusion Criteria:

Previous arthritis
Pathological fracture
Chronic corticosteroid use
Concomitant lower extremity fractures

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dror Lakstein, MD	Contact	++972-3-5028383		drorale@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
E. WOlfson medical center	Recruiting	Holon		58100	Israel