INBONE Total Ankle Arthroplasty(TAA)Using Calcaneal Stem... | NCT01366989

Studies
INBONE Total Ankle Arthroplasty(TAA)Using Calcaneal Stem Fixation

NCT01366989

Sponsor

Stryker Trauma and Extremities

Status

Terminated

Last Update Posted

Feb 17, 2017Actual

Enrollment

24Actual

Phase

Not provided

Conditions

Arthrodesis
Degenerative Arthritis
Rheumatoid Arthritis
Complications; Arthroplasty, Mechanical

Interventions

Radiographic evaluation of previously implanted patients

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

Feb 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The retrospective data review did not provide adequate information to continue the investigation.

Expanded Access Info

Start Date

Oct 2010Actual

Primary Completion Date

Jun 4, 2013Actual

Completion Date

Jun 4, 2013Actual

First Submitted Date

Jun 2, 2011

First Submission Date that Met QC Criteria

Jun 2, 2011

First Posted Date

Jun 6, 2011Estimated

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

Feb 15, 2017

Last Update Posted Date

Feb 17, 2017Actual

Name	Class
Duke University	OTHER

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 primary objective of this study is to evaluate the radiographic outcomes of Total Ankle Arthroplasty in patients having a calcaneal stem.

Detailed Description

The primary objective of this study is to determine the radiographic outcomes of patients who have received TAA with the calcaneal stem. Due to the fixation of the stem in the calcaneus, talar component position, osteolysis and bone quality are of interest to the FDA. Specifically, subsidence and/or migration of the talar component, osteolysis as a measure of wear, and bone quality of the talus, cuboid and navicular are to be evaluated in this study. Therefore, the radiographic outcomes of this study aim to assess these parameters

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

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Total Ankle Arthroplasty with calcaneal stem		Patients received the TAA with calcaneal stem between 12/6/05 & 11/13/07 at approximately 28 sites.	Device: Radiographic evaluation of previously implanted patients

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radiographic evaluation of previously implanted patients	Device	Radiographs of the ankle	Total Ankle Arthroplasty with calcaneal stem

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Radiographic Evaluation	Bone quality of the talus, navicular, and cuboid will be assessed on both the lateral and mortise views of the latest follow-up radiographs	Post operarative 1.2 -3.1 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who will be recruited for participation in this study received the TAA with calcaneal stem between December 6, 2005 and November 13, 2007 at approximately 28 sites.

Exclusion Criteria:

Patients who will be recruited for participation in this study received the TAA with calcaneal stem between December 6, 2005 and November 13, 2007 at approximately 28 sites.

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

Patients who will be recruited for participation in this study received the TAA with calcaneal stem between December 6, 2005 and November 13, 2007 at approximately 28 sites.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Bolognesi, MD	Duke University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Michael Bolognesi, MD		Durham	North Carolina	27705	United States

Condition Browse Module

MeSH Terms

ID	Term
D000844	Ankylosis
D010003	Osteoarthritis
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D001168	Arthritis
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided