Avascular Necrosis (AVN) Long-Term Follow-up
This study has been terminated.
Information provided by (Responsible Party):
First received: January 28, 2009
Last updated: December 20, 2011
Last verified: December 2011
Long-term follow-up of IDE patients for publication
Femoral Head Collapse
||Hedrocel Avascular Necrosis (AVN) Intervention Implant
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 ]
| Study Start Date:
| Estimated Study Completion Date:
| 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.
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- Patient qualifies for core decompression based on physical exam
- No history of core decompression
- Patient is willing and able to provide written informed consent
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00833430
|Emory Orthopedic Clinic
|Atlanta, Georgia, United States, 30329 |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 28, 2009
||December 20, 2011
||United States: Institutional Review Board
Keywords provided by Zimmer, Inc.:
Femoral Head Collapse
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 28, 2015