Comparison Study of Biofoam Porous Metal Versus Allograft... | NCT00949897

Studies
Comparison Study of Biofoam Porous Metal Versus Allograft to Treat Adult Acquired Flatfoot

NCT00949897

Sponsor

OrthoCarolina Research Institute, Inc.

Status

Withdrawn

Last Update Posted

Mar 13, 2013Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

Adult Acquired Flatfoot

Interventions

Biofoam
Iliac Crest Allograft with locked plate

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

Mar 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Funding terminated

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Jul 29, 2009

First Submission Date that Met QC Criteria

Jul 29, 2009

First Posted Date

Jul 31, 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

Mar 11, 2013

Last Update Posted Date

Mar 13, 2013Estimated

Name	Class
Stryker Trauma and Extremities	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 compare the clinical and radiographic outcomes of a randomized, consecutive series of adult patients, with an acquired flatfoot, treated with a lateral column lengthening using an allograft bone wedge versus a titanium porous metal implant (Biofoam, Wright Medical).

Null hypothesis: At six months postoperatively, there is no difference in the degree of correction as measured by the talonavicular coverage angle between patients randomized to allograft and Biofoam.

Alternative hypothesis: At six months postoperatively, the degree of correction as measured by the talonavicular coverage angle will be less in patients randomized to allograft than the degree of correction in patients randomized to Biofoam.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Biofoam	Active Comparator		Device: Biofoam
Iliac Crest Allograft with locked plate	Active Comparator		Other: Iliac Crest Allograft with locked plate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biofoam	Device	Device	Biofoam	510(k) Number: K073535

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The degree of correction as measured by talonavicular coverage angle, which is used to quantify the degree of deformity. Degree of correction is defined as the difference between the preoperative and postoperative talonavicular coverage angle.		2 weeks, 6 weeks, 12 weeks, and 6 months

Secondary Outcomes

Measure	Description	Time Frame
American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score		2 weeks, 6 weeks, 3 months, and 6 months
Foot Function Index (FFI) Score		2 weeks, 6 weeks, 3 months, and 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ages 25-75
Unresponsive to conservative treatment
Patient with acquired flatfoot deformity, who is a candidate for lateral column lengthening (Stage IIB) = (greater than > 40% uncoverage of talar head by navicular on standing AP radiograph)

Exclusion Criteria:

Less than 25 years of age and greater than 75 years
Pre-existing infection
Peripheral neuropathy
Charcot arthropathy
Peripheral vascular disease
Rhematoid Arthritis (RA) or inflammatory arthropathy
Metal allergy or sensitivity to metal

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert B Anderson, MD	OrthoCarolina, P.A.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
OrthoCarolina, P.A.		Charlotte	North Carolina	28203	United States