Evaluation of Partial and Total Femoral Replacement | NCT03045536

Studies
Evaluation of Partial and Total Femoral Replacement

NCT03045536

Sponsor

Technical University of Munich

Status

Unknown status

Last Update Posted

Apr 25, 2017Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Survival, Prostheses

Interventions

MML (Fa. ESKA/Orthodynamics)

Countries

Germany

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

Feb 2017

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

Jan 1, 2016Actual

Primary Completion Date

Mar 1, 2018Estimated

Completion Date

Apr 1, 2019Estimated

First Submitted Date

Feb 4, 2017

First Submission Date that Met QC Criteria

Feb 6, 2017

First Posted Date

Feb 7, 2017Estimated

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 24, 2017

Last Update Posted Date

Apr 25, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Harrasser, Principal Investigator, Technical University of MunichPrincipal Investigator

Lead Sponsor

Technical University of MunichOTHER

Collaborators

Not provided

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

Several surgical options for the reconstruction of massive bone defects have been described and include biologic methods with autografts and allografts, and the use of tumor endoprostheses (total femoral replacement, TFR). Several types of modular TFR are available, but nevertheless unpredictable outcomes and high complication rates have been described from most authors. The aim of the present study was to compare complication rates after TFR performed with modular total femur prosthesis MML (Fa. ESKA/Orthodynamics) in patients with and without malignant disease.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with TFR		Patients treated with TFR for oncologic or non-oncologic reason	Device: MML (Fa. ESKA/Orthodynamics)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MML (Fa. ESKA/Orthodynamics)	Device	Classification of complications according to MSTS	Patients with TFR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survival of device	Any device-related complications are defined failure	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Total or partial femoral replacement

Exclusion Criteria:

Failure of device

Accepts Healthy Volunteers

Not provided

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

The investigators retrospectivel review our institution's database for patients who underwent resection of the partial or whole femur due to bone tumors or failed revision arthroplasties and reconstruction by TFR from January 1995 to January 2011.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
norbert harrasser	Contact	15232716657		norbert.harrasser@gmx.net

Overall Officials

Name	Affiliation	Role
norbert harrasser	Klinikum rechts der Isar	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum rechts der Isar	Recruiting	Munich		80992	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided