Status:
TERMINATED
Avascular Necrosis (AVN) Long-Term Follow-up
Lead Sponsor:
Zimmer Biomet
Conditions:
Avascular Necrosis
Femoral Head Collapse
Eligibility:
All Genders
18-75 years
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00833430
Start Date
June 1 2006
End Date
February 1 2013
Last Update
February 19 2016
Active Locations (1)
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1
Emory Orthopedic Clinic
Atlanta, Georgia, United States, 30329