Post-Market Study of the ICONACY Hip System

NCT02027974 | Withdrawn DMC

• 1 other identifier: 13-1-M-239
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the use and efficacy of the Iconacy Hip System for total hip replacement surgery.

Conditions

Degenerative Joint Disease

Keywords

Hip; Arthroplasty; Arthroplasties; Prosthesis; Iconacy; Osteoarthritis; Arthritis; THA; THR; DJD

Outcome Measures

Primary Outcomes (3)

• 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 (3)

• 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

  1, 2, and 3 years

Study Arms (2)

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

Iconacy Hip System DEVICE

Comparison of Iconacy I-Hip system to the Stryker Accolade hip system using a randomized study.

Also known as: Iconacy I-Hip, I-Hip, iHip

Iconacy Hip System

Stryker Accolade Hip System DEVICE

Comparison of Iconacy I-Hip system to the Stryker Accolade hip system using a randomized study.

Also known as: Accolade

Stryker Accolade Hip System

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Iconacy Orthopedic Implants, LLC.: lead

MeSH Terms

Conditions

Joint Diseases; Osteoarthritis; Arthritis

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• William A Hodge, MD

  Eastern Maine Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2014
• First Posted: January 6, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 13, 2014

Record last verified: 2014-05