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Sponsored by: |
Zimmer, Inc. |
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Information provided by: | Zimmer, Inc. |
ClinicalTrials.gov Identifier: | NCT00833430 |
Long-term follow-up of IDE patients for publication
Condition |
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Avascular Necrosis Femoral Head Collapse |
Study Type: | Observational |
Official Title: | Hedrocel Avascular Necrosis (AVN) Intervention Implant |
Enrollment: | 35 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Patients enrolled at investigational sites who had Stage I or Stage II Osteonecrosis of the femoral head and who would qualify for core decompression based upon physical and radiographic exam and medical history.
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Zimmer, Inc ( Kim Rowe, CRS ) |
Study ID Numbers: | IC006-99 |
Study First Received: | January 28, 2009 |
Last Updated: | January 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00833430 History of Changes |
Health Authority: | United States: Institutional Review Board |
AVN Femoral Head Collapse |
Necrosis Musculoskeletal Diseases Osteonecrosis Bone Diseases |
Necrosis Pathologic Processes Musculoskeletal Diseases Osteonecrosis Bone Diseases |