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Avascular Necrosis (AVN) Long-Term Follow-up

Primary Purpose

Avascular Necrosis, Femoral Head Collapse

Status

Terminated

Phase

Locations

United States

Study Type

Observational

Intervention

About this trial

This is an observational trial for Avascular Necrosis focused on measuring AVN, Femoral Head Collapse

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Emory Orthopedic Clinic

Outcomes

Primary Outcome Measures

Safety, Efficacy and longevity of device with patient as opposed to conventional total hip replacement

Secondary Outcome Measures

Full Information

NCT ID

NCT00833430

First Posted

January 28, 2009

Last Updated

February 18, 2016

Sponsor

Zimmer Biomet

1. Study Identification

Unique Protocol Identification Number

NCT00833430

Brief Title

Avascular Necrosis (AVN) Long-Term Follow-up

Official Title

Hedrocel Avascular Necrosis (AVN) Intervention Implant

Study Type

Observational

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Terminated

Study Start Date

June 2006 (undefined)

Primary Completion Date

February 2013 (Actual)

Study Completion Date

February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zimmer Biomet

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Avascular Necrosis, Femoral Head Collapse

Keywords

AVN, Femoral Head Collapse

7. Study Design

Enrollment

35 (Actual)

Primary Outcome Measure Information:

Title

Safety, Efficacy and longevity of device with patient as opposed to conventional total hip replacement

Time Frame

5 Year Follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Study Population Description

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.

Sampling Method

Non-Probability Sample

Facility Information:

Facility Name

Emory Orthopedic Clinic

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30329

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Avascular Necrosis (AVN) Long-Term Follow-up

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