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Avascular Necrosis (AVN) Long-Term Follow-up

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Zimmer, Inc.
ClinicalTrials.gov Identifier:
NCT00833430
First received: January 28, 2009
Last updated: February 18, 2016
Last verified: February 2016

January 28, 2009
February 18, 2016
June 2006
February 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00833430 on ClinicalTrials.gov Archive Site
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Not Provided
 
Avascular Necrosis (AVN) Long-Term Follow-up
Hedrocel Avascular Necrosis (AVN) Intervention Implant
Long-term follow-up of IDE patients for publication
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.
Observational
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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.
  • Avascular Necrosis
  • Femoral Head Collapse
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
35
February 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00833430
IC006-99
No
Not Provided
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Zimmer, Inc.
Zimmer, Inc.
Not Provided
Not Provided
Zimmer, Inc.
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP