Avascular Necrosis (AVN) Long-Term Follow-up

NCT ID: NCT00833430

Last Updated: 2016-02-19

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2013-02-28

Brief Summary

Long-term follow-up of IDE patients for publication

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.

Conditions

Avascular Necrosis; Femoral Head Collapse

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Emory Orthopedic Clinic

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

IC006-99

Identifier Type: -

Identifier Source: org_study_id