Avascular Necrosis (AVN) Long-Term Follow-up
This study has been terminated.
Sponsor:
Zimmer, Inc.
Information provided by (Responsible Party):
Zimmer, Inc.
ClinicalTrials.gov Identifier:
NCT00833430
First received: January 28, 2009
Last updated: December 20, 2011
Last verified: December 2011
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Purpose
Long-term follow-up of IDE patients for publication
| Condition |
|---|
|
Avascular Necrosis Femoral Head Collapse |
| Study Type: | Observational |
| Official Title: | Hedrocel Avascular Necrosis (AVN) Intervention Implant |
Resource links provided by NLM:
Further study details as provided by Zimmer, Inc.:
Primary Outcome Measures:
- Safety, Efficacy and longevity of device with patient as opposed to conventional total hip replacement [ Time Frame: 5 Year Follow-up ] [ Designated as safety issue: No ]
| Enrollment: | 35 |
| Study Start Date: | June 2006 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
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.
Criteria
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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Zimmer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00833430 History of Changes |
| Other Study ID Numbers: | IC006-99 |
| Study First Received: | January 28, 2009 |
| Last Updated: | December 20, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Zimmer, Inc.:
|
AVN Femoral Head Collapse |
Additional relevant MeSH terms:
|
Necrosis Osteonecrosis Shock |
Pathologic Processes Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on June 18, 2013