Avascular Necrosis (AVN) Long-Term Follow-up

Avascular Necrosis Clinical Trial

Official title:

Hedrocel Avascular Necrosis (AVN) Intervention Implant

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00833430
• Other study ID #: IC006-99
• Status: Terminated
• Phase: N/A
• First received: January 28, 2009
• Last updated: February 18, 2016
• Start date: June 2006
• Est. completion date: February 2013

Study information

• Verified date: February 2016
• Source: Zimmer, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Long-term follow-up of IDE patients for publication

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Avascular Necrosis
• Femoral Head Collapse
• Necrosis
• Osteonecrosis

Locations

Country	Name	City	State
United States	Emory Orthopedic Clinic	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety, Efficacy and longevity of device with patient as opposed to conventional total hip replacement		5 Year Follow-up	No