Avascular Necrosis (AVN) Long-Term Follow-up

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ClinicalTrials.gov Identifier: NCT00833430

Recruitment Status : Terminated

First Posted : February 2, 2009

Last Update Posted : February 19, 2016

Sponsor:

Information provided by (Responsible Party):

Zimmer Biomet

Study Description

Brief Summary:

Long-term follow-up of IDE patients for publication

Condition or disease
Avascular Necrosis Femoral Head Collapse

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 Design


Study Type :	Observational
Actual Enrollment :	35 participants
Official Title:	Hedrocel Avascular Necrosis (AVN) Intervention Implant
Study Start Date :	June 2006
Actual Primary Completion Date :	February 2013
Actual Study Completion Date :	February 2013

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
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.

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00833430

Locations


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

Sponsors and Collaborators

Zimmer Biomet

More Information


Responsible Party:	Zimmer Biomet
ClinicalTrials.gov Identifier:	NCT00833430 History of Changes
Other Study ID Numbers:	IC006-99
First Posted:	February 2, 2009 Key Record Dates
Last Update Posted:	February 19, 2016
Last Verified:	February 2016

Keywords provided by Zimmer Biomet:


AVN Femoral Head Collapse

Additional relevant MeSH terms:


Necrosis Osteonecrosis Shock	Pathologic Processes Bone Diseases Musculoskeletal Diseases

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