Avascular Necrosis (AVN) Long-Term Follow-up

February 18, 2016 updated by: Zimmer Biomet

Hedrocel Avascular Necrosis (AVN) Intervention Implant

Long-term follow-up of IDE patients for publication

Study Overview

Status

Terminated

Conditions

Detailed Description

This device (Hedrocel AVN Intervention Implant) was approved via 510(k) on April 15, 2005. One site was left open to follow patients to 5 year follow-up for publication of device survivorship.

Study Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Emory Orthopedic Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients enrolled at investigational sites who had Stage I or Stage II Osteonecrosis of the femoral head and who would qualify for core decompression based upon physical and radiographic exam and medical history.

Description

Inclusion Criteria:

  • Patient qualifies for core decompression based on physical exam
  • No history of core decompression
  • Patient is willing and able to provide written informed consent

Exclusion Criteria:

  • Patient has been diagnosed as Stage 0, III, IV, V or VI using the Steinberg/UPenn staging system.
  • Patient's BMI is >40
  • Patient is mentally compromised
  • Patient has neurological condition in ipsilateral or contralateral limb, which affect lower limb function
  • The patient has had a proximal femoral osteotomy or internal fixation in the affected hip.
  • The patient has undergone previous treatment for AVN
  • Previous hip conditions
  • Patient's bone stock is insufficient
  • Patient has diagnosed systemic disease
  • Patient is a pregnant female
  • Patient is unable or unwilling to attend postop follow-up visits
  • Patient has received investigational drug within the previous 6 months or an investigational device within the last 12 months
  • Patient has an active or latent infection
  • Patient has metal sensitivity
  • Patient is a prisoner

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety, Efficacy and longevity of device with patient as opposed to conventional total hip replacement
Time Frame: 5 Year Follow-up
5 Year Follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

January 28, 2009

First Submitted That Met QC Criteria

January 29, 2009

First Posted (Estimate)

February 2, 2009

Study Record Updates

Last Update Posted (Estimate)

February 19, 2016

Last Update Submitted That Met QC Criteria

February 18, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IC006-99

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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