NCT02131389

Brief Summary

The purpose of this study is to evaluate the use and efficacy of the I-Hip for primary total hip replacement surgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 6, 2014

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

May 6, 2014

Status Verified

May 1, 2014

Enrollment Period

5.7 years

First QC Date

April 28, 2014

Last Update Submit

May 2, 2014

Conditions

Degenerative Joint Disease

Keywords

HipArthroplastyArthroplastiesProsthesisIconacyOsteoarthritisArthritisTHATHRDJD

Outcome Measures

Primary Outcomes (3)

  • Radiographic Success as a Measure of Radiolucency and Component Migration

    A subject will be considered a failure for Overall Radiographic Success if one or more of the below conditions are met: The subject will be considered a RADIOGRAPHIC FAILURE if: 1. there is a complete radiolucent line\> 3mm wide at the bone/cement interface or 2. there is a \>5 degree migration (shift) of the component or 3. there is a \>5 mm migration (shift) of the component.

    2 years

  • Improvement of Harris Hip Score (with Charnley Score and other comorbidities considered)

    2 years

  • Patient satisfaction clinical assessment utilizing questionnaire

    Clinical assessment of patient satisfaction will be made by utilizing a Patient Satisfaction (PS) questionnaire.

    2 years

Secondary Outcomes (1)

  • Revision of Implant Prosthesis as a Measure of Efficacy

    5 years

Study Arms (1)

Iconacy Hip System

OTHER

Iconacy hip system prosthesis components

Device: Iconacy Hip System

Interventions

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

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A candidate for primary hip replacement on this operative hip.
  • Is 30 to 80 years of age.
  • Has hip joint disease related to one or more of the following:
  • Degenerative joint disease, (including osteoarthritis or post-traumatic arthritis)
  • Avascular Necrosis (AVN).
  • Will be available for evaluation for the duration of the study.
  • Is able and willing to speak and read English, read and sign the informed consent, fill out the WOMAC and Patient Satisfaction questionnaires, and follow all study procedures.

You may not qualify if:

  • Is younger than 30 years of age or older than 80 years of age.
  • Has undergone partial hip replacement or previous ORIF (open reduction internal fixation of femur or acetabulum).
  • Has undergone total hip replacement on this hip in the past (no revisions allowed in study).
  • Infection, or history of infection, acute or chronic, in the hip joint, or acute or chronic unresolved systemic infection.
  • Is currently experiencing radicular pain from the spine down operative leg.
  • Has participated in an IDE/IND clinical investigation with an investigational product in the last three months, or is involved in any personal injury litigation, medical-legal or worker's compensation claim.
  • Is a known drug or alcohol abuser or has a psychological disorder that could affect the ability to complete patient reported questionnaires.
  • Has been diagnosed with fibromyalgia or has a significant neurological or musculoskeletal disorder or disease that may adversely affect gait or weight bearing (e.g. muscular dystrophy, multiple sclerosis, Charcot disease).
  • Has been diagnosed with Paget's disease or Congenital hip deformity (dysplasia and/or dislocation).
  • Is suffering from inflammatory arthritis (e.g. rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.)
  • Is Obese: (Defined for this study as having a BMI\>45).
  • Has insufficient bone quality.
  • Has loss of ligamentous structures.
  • Has materials sensitivity.
  • Is currently a prisoner.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Baptist Health Louisville

Louisville, Kentucky, 40207, United States

RECRUITING

Sts. Mary & Elizabeth Hospital - KentuckyOne Health

Louisville, Kentucky, 40215, United States

RECRUITING

MeSH Terms

Conditions

Joint DiseasesOsteoarthritisArthritis

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Donald L Pomeroy, MD

    Pomeroy & Rhoads Orthopaedics, Inc.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Donald L Pomeroy, MD

CONTACT

502-364-9883arthroplastyfoundation@gmail.com

Jan Empson, RN

CONTACT

502-364-0902empsonja@aol.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2014

First Posted

May 6, 2014

Study Start

April 1, 2014

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

May 6, 2014

Record last verified: 2014-05

Locations

US(2)