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
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 April 22, 2014