Prospective Trial on Trochanteric Femur Fractures Treated... | NCT00626470

Studies
Prospective Trial on Trochanteric Femur Fractures Treated With or Without a Trochanter Support Plate

NCT00626470

Sponsor

St. Olavs Hospital

Status

Completed

Last Update Posted

Oct 2, 2017Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Femoral Fractures

Interventions

Addition of TSP to DHS

Countries

Norway

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

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008Actual

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2014Actual

First Submitted Date

Feb 15, 2008

First Submission Date that Met QC Criteria

Feb 28, 2008

First Posted Date

Feb 29, 2008Estimated

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

Sep 28, 2017

Last Update Posted Date

Oct 2, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Fractures just below the hip often are treated with a so called Gliding Screw and Plate (DHS). Recently a new additional plate called a Trochanter Support Plate (TSP) which attaches to the DHS has become available which is claimed to give extra support to the fracture. In a prospective randomised study we wish to test the hypothesis that the TSP does not give any additional stability to the fracture treated with the DHS.

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

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
-TSP	Active Comparator	Patients operated without TSP	Procedure: Addition of TSP to DHS
+TSP	Active Comparator	Patients operated with TSP	Procedure: Addition of TSP to DHS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Addition of TSP to DHS	Procedure	All patients operated with DHS. Of these two groups. One operated with TSP and one without.	+TSP -TSP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fracture movement postoperatively		One year

Secondary Outcomes

Measure	Description	Time Frame
Reoperation		One year
Pain postoperatively		one year
Hip function postoperatively

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of unstable trochanteric femur fracture.(Evans-Jensen class.3-5)
(can include; Patients with cognitive problems (ie. dementia etc)

Exclusion Criteria:

Patients with pathological fractures
Multitrauma patients
Patients not able to walk before the fracture
Under 19 years old.
Patients with fractures needing other treatments than gliding hip screws
Reverse oblique fractures.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
James Haddon, MD	St. Olavs Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ortopaedic Department, St.Olavs Hospital		Trondheim		7000	Norway

Condition Browse Module

MeSH Terms

ID	Term
D005264	Femoral Fractures
D050723	Fractures, Bone

Ancestor Terms

ID	Term
D014947	Wounds and Injuries
D007869	Leg Injuries

Browse Leaves

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Browse Branches

Not provided