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: December 20, 2011
Last verified: December 2011
  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)
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.

  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
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

Locations
United States, Georgia
Emory Orthopedic Clinic
Atlanta, Georgia, United States, 30329
Sponsors and Collaborators
Zimmer, Inc.
  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 July 22, 2014