Avascular Necrosis (AVN) Long-Term Follow-up
Terminated
- Conditions
- Avascular NecrosisFemoral Head Collapse
- Registration Number
- NCT00833430
- Lead Sponsor
- Zimmer Biomet
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 35
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety, Efficacy and longevity of device with patient as opposed to conventional total hip replacement 5 Year Follow-up
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Emory Orthopedic Clinic
🇺🇸Atlanta, Georgia, United States