Avascular Necrosis (AVN) Long-Term Follow-up

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