Avascular Necrosis (AVN) Long-Term Follow-up
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ClinicalTrials.gov Identifier: NCT00833430 |
Recruitment Status
:
Terminated
First Posted
: February 2, 2009
Last Update Posted
: February 19, 2016
|
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Condition or disease |
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Avascular Necrosis Femoral Head Collapse |
Study Type : | Observational |
Actual Enrollment : | 35 participants |
Official Title: | Hedrocel Avascular Necrosis (AVN) Intervention Implant |
Study Start Date : | June 2006 |
Actual Primary Completion Date : | February 2013 |
Actual Study Completion Date : | February 2013 |
- Safety, Efficacy and longevity of device with patient as opposed to conventional total hip replacement [ Time Frame: 5 Year Follow-up ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00833430
United States, Georgia | |
Emory Orthopedic Clinic | |
Atlanta, Georgia, United States, 30329 |
Responsible Party: | Zimmer Biomet |
ClinicalTrials.gov Identifier: | NCT00833430 History of Changes |
Other Study ID Numbers: |
IC006-99 |
First Posted: | February 2, 2009 Key Record Dates |
Last Update Posted: | February 19, 2016 |
Last Verified: | February 2016 |
Keywords provided by Zimmer Biomet:
AVN Femoral Head Collapse |
Additional relevant MeSH terms:
Necrosis Osteonecrosis Shock |
Pathologic Processes Bone Diseases Musculoskeletal Diseases |