Post Market Clinical Follow-Up of Acetabular Titan-Augmen... | NCT02019433

Studies
Post Market Clinical Follow-Up of Acetabular Titan-Augment Structan®

NCT02019433

Sponsor

Aesculap AG

Status

Terminated

Last Update Posted

Jan 26, 2017Estimated

Enrollment

5Actual

Phase

Not provided

Conditions

Total Hip Arthroplasty Revision

Interventions

Structan®

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

Jan 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Sep 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Dec 5, 2013

First Submission Date that Met QC Criteria

Dec 18, 2013

First Posted Date

Dec 24, 2013Estimated

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

Jan 25, 2017

Last Update Posted Date

Jan 26, 2017Estimated

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

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

5Actual

Label	Type	Description	Intervention Names
Structan®			Device: Structan®

Name	Type	Description	Arm Group Labels	Other Names
Structan®	Device		Structan®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Implant Survival Rates	Implant survival is analysed at follow-up examinations at 3 and 12 months	12 months

Secondary Outcomes

Measure	Description	Time Frame
Clinical Outcome	Harris Hip Score	3 and 12 months
Pain	Visual Analogue Scale (VAS)	3 and 12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Minimum age 18 years
Indication for cementless hip arthroplasty with acetabular defects that need Allograft or titanium augment
Patient consent for study participation
Physical and mental willingness to participate in the follow-ups

Exclusion Criteria:

Patient not available for follow-up
Increased anesthetics risks for the patient according to the "American Society of Anesthesiology": ASA IV
Tumor
Alcohol- or Drug abuse
Permanent cortisone therapy
Clinically relevant infection
(Planned) pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

specialist clinical centre

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charite Campus Berlin Mitte		Berlin		10117	Germany
Klinik am Eichert