Cemented vs Non-cemented Semiendoprosthesis in the Treatm... | NCT00859378

Studies
Cemented vs Non-cemented Semiendoprosthesis in the Treatment of Proximal Femoral Fractures

NCT00859378

Sponsor

Kuopio University Hospital

Status

Unknown status

Last Update Posted

Apr 7, 2015Estimated

Enrollment

400Estimated

Phase

Not Applicable

Conditions

Hip Fracture
Proximal Femoral Fracture

Interventions

Cemented semiendoprosthesis
non-cemented

Countries

Finland

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

Apr 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2015Estimated

First Submitted Date

Mar 10, 2009

First Submission Date that Met QC Criteria

Mar 10, 2009

First Posted Date

Mar 11, 2009Estimated

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

Apr 3, 2015

Last Update Posted Date

Apr 7, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tero Yli-Kyyny, M.D., Kuopio University HospitalPrincipal Investigator

Lead Sponsor

Kuopio University HospitalOTHER

Collaborators

Name	Class
The Finnish Research Foundation for Orthopaedics and Traumatology	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The hip semiendoprosthesis is an acceptable method to treat the proximal femoral fractures. Traditionally, the cemented version of the semiendoprosthesis has been used for this indication. However, the cementing carries a risk of fat embolism during the pressurization of the cement. The fat embolism can be avoided when using the non-cemented semiendoprosthesis. In this study we want to find out whether there are any differences in the treatment results between the cemented and non-cemented semiendoprostheses when treating the proximal femoral fractures.

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

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1 - cemented	Active Comparator	Patients are treated with a cemented semiendoprosthesis	Device: Cemented semiendoprosthesis
2 - non-cemented	Active Comparator	Patients are treated with a non-cemented semiendoprosthesis	Device: non-cemented

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cemented semiendoprosthesis	Device	Application of a cemented semiendoprosthesis (Basis, Smith & Nephew)	1 - cemented

Measure	Description	Time Frame
Primary mortality		3 months

Measure	Description	Time Frame
Prosthetic complications		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A proximal femoral fracture

Exclusion Criteria:

Rheumatoid arthritis
Pathologic fracture
Severe dementia (preventing the informed consent)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Central Hospital of North Carelia		Joensuu		80200	Finland
Kuopio University Hospital

Condition Browse Module

MeSH Terms

ID	Term
D006620	Hip Fractures
D000092526	Proximal Femoral Fractures
D005264	Femoral Fractures

Ancestor Terms

ID	Term
D050723	Fractures, Bone
D014947	Wounds and Injuries
D025981	Hip Injuries
D007869	Leg Injuries

Browse Leaves

Not provided

Browse Branches

Not provided