Post-Market Study of the ICONACY Hip System | NCT02027974

Studies
Post-Market Study of the ICONACY Hip System

NCT02027974

Sponsor

Iconacy Orthopedic Implants, LLC.

Status

Withdrawn

Last Update Posted

May 13, 2014Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Degenerative Joint Disease

Interventions

Iconacy Hip System
Stryker Accolade Hip System

Countries

Not provided

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

May 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Dec 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Jan 3, 2014

First Submission Date that Met QC Criteria

Jan 3, 2014

First Posted Date

Jan 6, 2014Estimated

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

May 12, 2014

Last Update Posted Date

May 13, 2014Estimated

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

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

Not Applicable

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
Iconacy Hip System	Active Comparator	Iconacy hip system prosthesis components	Device: Iconacy Hip System
Stryker Accolade Hip System	Active Comparator	Stryker Accolade hip system prosthesis components	Device: Stryker Accolade Hip System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Iconacy Hip System	Device	Comparison of Iconacy I-Hip system to the Stryker Accolade hip system using a randomized study.	Iconacy Hip System

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Radiographic success		2 years
Harris Hip Score must be > or = 80 at 2 years		2 years
Oxford Hip Score > 40 points at 2 years		2 years

Secondary Outcomes

Measure	Description	Time Frame
Patient Satisfaction at 1, 2, and 3 years		1, 2, and 3 years
Improvement in Harris Hip Score from pre-surgery to 1, 2, and 3 years		1, 2, and 3 years
Improvements in Oxford Hip Score from pre-survey to 1, 2, and 3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

This must be a primary hip replacement on this hip
Patient is 30 years of age or older
Have hip joint disease related to one or more of the following: degenerative joint disease, including osteoarthritis or traumatic arthritis
Patient is likely to be available for evaluation for the duration of the study
Able and willing to sign the informed consent and follow study procedures

Exclusion Criteria:

Is younger than 30 years of age
If there has been a total hip replacement on this hip in the past (no revisions allowed in study)
Infection, or history of infection, acute or chronic, local or systemic
Alcoholism or other addictions
Muscular, neurological or vascular deficiencies which compromise the affected extremity
Obesity(BMI>45)
Insufficient bone quality
Loss of ligamentous structures
High levels of physical activity
Materials sensitivity
Prisoner
Mental conditions that may interfere with the patient's ability to give an informed consent or willingness to fulfill the study requirements
Patient is pregnant
Is not able to read English language

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
William A Hodge, MD	Eastern Maine Medical Center	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D007592	Joint Diseases
D010003	Osteoarthritis
D001168	Arthritis

Ancestor Terms

ID	Term
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided