Avascular NecrosisNCT00833430
Avascular Necrosis (AVN) Long-Term Follow-up
An observational study of Avascular Necrosis and Femoral Head Collapse, run by Zimmer Biomet at 1 site in United States.
Trial summary
Long-term follow-up of IDE patients for publication Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Avascular Necrosis, Femoral Head Collapse
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Feb 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Patient qualifies for core decompression based on physical exam
- No history of core decompression
- Patient is willing and able to provide written informed consent
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hedrocel Avascular Necrosis (AVN) Intervention Implant
Long-term follow-up of IDE patients for publication
Read the 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
- Keywords
- AVN, Femoral Head Collapse
- Medical subject headings
- Osteonecrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, Efficacy and longevity of device with patient as opposed to conventional total hip replacement
Measured: 5 Year Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2009 (estimated)
- Study startJun 2006
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Avascular NecrosisStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833430
- Sponsor's protocol ID
- IC006-99
- Status last verified
- Feb 2016
- First submitted
- 28 Jan 2009
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hedrocel Avascular Necrosis (AVN) Intervention Implant
- ClinicalTrials.gov ID
- NCT00833430
- Acronym / sponsor ID
- IC006-99
- Conditions
- Avascular Necrosis, Femoral Head Collapse
- Keywords
- AVN, Femoral Head Collapse
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 2 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patient qualifies for core decompression based on physical exam
- No history of core decompression
- Patient is willing and able to provide written informed consent
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety, Efficacy and longevity of device with patient as opposed to conventional total hip replacement
Time frame: 5 Year Follow-up
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Avascular Necrosis and Femoral Head Collapse, run by Zimmer Biomet at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety, Efficacy and longevity of device with patient as opposed to conventional total hip replacement (time frame: 5 Year Follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2016.