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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
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Brief Summary:
Long-term follow-up of IDE patients for publication

Condition or disease
Avascular Necrosis Femoral Head Collapse

Detailed Description:
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.

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



Primary Outcome Measures :
  1. 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
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

Information from the National Library of Medicine

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


Locations
United States, Georgia
Emory Orthopedic Clinic
Atlanta, Georgia, United States, 30329
Sponsors and Collaborators
Zimmer Biomet

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