Management of Bone Defects Around the Elbow | NCT00873145

Studies
Management of Bone Defects Around the Elbow

NCT00873145

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

Apr 15, 2015Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Tumor
Fracture
Cancer

Interventions

HMRS

Countries

Austria

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

Mar 2009

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 2008

Primary Completion Date

Sep 2009Actual

Completion Date

Jan 2010Actual

First Submitted Date

Mar 31, 2009

First Submission Date that Met QC Criteria

Mar 31, 2009

First Posted Date

Apr 1, 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 14, 2015

Last Update Posted Date

Apr 15, 2015Estimated

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

Background:

Bone defects of the distal humerus require complex reconstructions, for which standard prostheses may be insufficient. The researchers therefore investigated the clinical and radiological outcome of elbow reconstructions by megaprostheses.

Detailed Description

Type of prosthesis:

STRYKER Humerus-HMRS

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Patients with major bone defects around the elbow.	Procedure: HMRS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HMRS	Procedure	Modular prosthetic replacement of the humerus and elbow.	1

Measure	Description	Time Frame
Patient Survival		20 Years

Measure	Description	Time Frame
Prosthetic Survival		20 Years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HMRS of the elbow, distal humerus or total humerus

Exclusion Criteria:

Unwillingness to participate

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

Patients with major bone defects around the elbow and/or distal humerus due to cancer or failed arthroplasty.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Vienna Department of Orthopaedics		Vienna		1090	Austria

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms
D050723	Fractures, Bone
D007239	Infections

Ancestor Terms

ID	Term
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided