A Retrospective Study of Actifuse Synthetic Bone Graft Ve... | NCT01833962

Studies
A Retrospective Study of Actifuse Synthetic Bone Graft Versus Other Bone Graft Substitutes in Patients Requiring Lumbar Fusion

NCT01833962

Sponsor

OrthoGeorgia

Status

Unknown status

Last Update Posted

Apr 21, 2015Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Lumbar Fusion

Interventions

Not provided

Countries

United States

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

Jan 2013

Primary Completion Date

Aug 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Apr 12, 2013

First Submission Date that Met QC Criteria

Apr 16, 2013

First Posted Date

Apr 17, 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

Apr 20, 2015

Last Update Posted Date

Apr 21, 2015Estimated

Name	Class
Baxter Healthcare Corporation	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 purpose of this study is to assess fusion status in patients who underwent spinal fusion with Actifuse synthetic bone graft versus other bone graft material (including autograft) in achieving lumbar spinal fusion.

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Actifuse		Patients who recieved Actifuse synthetic bone brafting material

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Achievement of fusion prior to or at 12 months postoperatively		6 - 12 months year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any patient 18 years of age or older
Patients with a minimum follow up of 1 year
Patients who have previously undergone TLIF, PLIF,PLF, XLIF procedures

Exclusion Criteria:

Patients under the age of 18
Any patient with less than 1 year of follow up history at the time of first data analysis
Any patient that the primary investigator deems as an unfit candidate

Accepts Healthy Volunteers

Yes

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

All study patients will be extracted from our current patient population. A total of 50 patients treated with Actifuse and 50 patients treated with other synthetic bone grafting substitutes

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
William B Dasher, MD	Physician	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
OrthoGeorgia		Macon	Georgia	31210	United States