Avascular Necrosis (AVN) Long-Term Follow-up

This study has been terminated.

Sponsor:

Information provided by (Responsible Party):

Zimmer, Inc.

ClinicalTrials.gov Identifier:

NCT00833430

First received: January 28, 2009

Last updated: February 18, 2016

Last verified: February 2016

History of Changes

Purpose

Long-term follow-up of IDE patients for publication

Condition
Avascular Necrosis Femoral Head Collapse


Study Type:	Observational
Official Title:	Hedrocel Avascular Necrosis (AVN) Intervention Implant

Further study details as provided by Zimmer, Inc.:

Primary Outcome Measures:

Safety, Efficacy and longevity of device with patient as opposed to conventional total hip replacement [ Time Frame: 5 Year Follow-up ] [ Designated as safety issue: No ]


Enrollment:	35
Study Start Date:	June 2006
Study Completion Date:	February 2013
Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

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.

Eligibility


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00833430

Locations


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

Sponsors and Collaborators

Zimmer, Inc.

More Information


Responsible Party:	Zimmer, Inc.
ClinicalTrials.gov Identifier:	NCT00833430 History of Changes
Other Study ID Numbers:	IC006-99
Study First Received:	January 28, 2009
Last Updated:	February 18, 2016
Health Authority:	United States: Institutional Review Board

Keywords provided by Zimmer, Inc.:


AVN Femoral Head Collapse

Additional relevant MeSH terms:


Necrosis Osteonecrosis Shock	Pathologic Processes Bone Diseases Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 26, 2016

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