Avascular Necrosis, Femoral Head Collapse
Conditions
Keywords
AVN, Femoral Head Collapse
Brief summary
Long-term follow-up of IDE patients for publication
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.
Interventions
None listed
Sponsors
Zimmer Biomet
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety, Efficacy and longevity of device with patient as opposed to conventional total hip replacement | 5 Year Follow-up |
Countries
United States
Outcome results
None listed