Avascular Necrosis (AVN) Long-Term Follow-up

Stopped early

Conditions studied: Avascular Necrosis, Femoral Head Collapse

In brief

Long-term follow-up of IDE patients for publication

Key facts

Study ID

NCT00833430

Run by

Zimmer Biomet

People needed

35

Starts

2006-06-01

Expected to finish

2013-02-01

Last updated by the study team

2016-02-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Emory Orthopedic Clinic — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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