Expired Study
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Atlanta, Georgia 30329


Long-term follow-up of IDE patients for publication

Study summary:

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.


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



Primary Contact:


Backup Contact:


Location Contact:

Atlanta, Georgia 30329
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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