Failure of Total HipNCT02239406
Acetabular Bone Vascularity in Metal-on-Metal Revisions
An observational study of Failure of Total Hip, run by OrthoCarolina Research Institute, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine if avascular necrosis of the acetabulum is present in metal-on-metal revisions and to what depth this dead avascular bone occurs. A convenient sample of a consecutive series of 15 patients treated for metal on metal acetabular revision surgery will be included. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Failure of Total Hip
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Apr 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A convenience sample of a total of 15 patients will be enrolled at OrthoCarolina.
Who may be able to join
- Patients being revised for an aseptic metal on metal acetabular revision.
- Patient is greater than one year postoperative.
- Patient has had cobalt and chromium metal ion levels tested within 6 months of the planned revision surgery.
- Understands the local language and is willing and able to follow the requirements of the protocol.
- Understands the informed consent and signs the institutional review board or independent ethics committee (IRB/IEC) approved informed consent form.
Who cannot join
- History of infection
- Evidence of current substance or alcohol abuse
- Being treated with radiation, chemotherapy, immunosupression, or chronic steroid therapy (prednisone use up to 5 mg/qd or its equivalent is allowed)
- Is a prisoner
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if avascular necrosis of the acetabulum is present in metal-on-metal revisions and to what depth this dead avascular bone occurs.
A convenient sample of a consecutive series of 15 patients treated for metal on metal acetabular revision surgery will be included.
Read the detailed description
Patients being treated for metal on metal acetabular revision surgery by a physician at OrthoCarolina, PA will be screened for eligibility. These patients will be approached by their surgeon and asked to volunteer their participation in the study. Potential subjects will meet with a research coordinator to discuss details of the study and those you volunteer participation will be asked to sign an informed consent prior to the collection of study data. . Basic demographic information (initials, age, gender, height, weight, BMI), dates of original index surgery, reason for revision, type of implant being removed, and standard of care cobalt and chromium metal ion levels will be collected via chart review.
Patients who meet all eligibility criteria will have three biopsies performed at the time of their revision surgery. A pathologist will note the presence or absence of bone necrosis and will measure the length (mm) of necrosis, acute inflammation, chronic inflammation, normal bone, and entire bone specimen in order to obtain a ratio.
Biopsy Protocol:
A bone biopsy is a procedure in which bone samples are removed (with a special instrument during surgery) and looked at under a microscope for necrosis (tissue death), infection, or other bone disorders. Once the acetabular hip replacement implants have been removed the following steps will occur:
- The biopsy needle will be inserted into the bone (3 locations; 2 from ilium, 1 from pubis or ischium = 3 total).
- The biopsy needle will be withdrawn and firm pressure will be applied to the biopsy site for a few minutes, until the bleeding has stopped.
- Each bone biopsy sample will be labeled sequentially and by anatomic location (i.e., ilium #1, ilium #2)
- The normal bone will be marked on the bone sample.
- The bone biopsy sample will be sent to the lab for examination.
- The acetabulum bone will be reamed so the new implant can be seated.
- Conditions
- Failure of Total Hip
- Keywords
- metal on metal total hip, avasuclar necrosis, acetabular revision, bone vascularity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Metal-on-Metal Revision | Patients who have a failed metal on metal total hip implant and are presenting for revision surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The depth (mm) of avascular bone from the acetabular surface per each patient
A bone biopsy is a procedure in which bone samples are removed (with a special instrument during surgery) and looked at under a microscope for necrosis (tissue death), infection, or other bone disorders. Once the acetabular hip replacement implants have been removed the following steps will occur:
- The biopsy needle will be inserted into the bone (3 locations; 2 from ilium, 1 from pubis or ischium = 3 total).
- The biopsy needle will be withdrawn and firm pressure will be applied to the biopsy site for a few minutes, until the bleeding has stopped.
- Each bone biopsy sample will be labeled sequentially and by anatomic location (i.e., ilium #1, ilium #2)
- The normal bone will be marked on the bone sample.
- The bone biopsy sample will be sent to the lab for examination.
Measured: participants will be followed for the duration of their surgery, an expected average of 2 hours
Secondary outcomes (1)
The ratio of necrotic bone per each patient
The ratio of each bone type (necrotic, acute inflammation, chronic inflammation, and normal bone) in relation to the length of the entire bone specimen will be measured.
Measured: paricipants will be followed for the duration of their surgery, an expected average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startNov 2014
- Primary completionApr 2016
- Study completionApr 2016
Why it stopped: Lack of enrollment interest.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Failure of Total HipStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- OrthoCarolina Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Presbyterian Pathology Group
- Responsible party
- Sponsor
- Investigators
- Thomas Fehring, MD, Principal investigator, OrthoCarolina Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02239406
- Sponsor's protocol ID
- HK025
- Status last verified
- Jul 2016
- First submitted
- 10 Sep 2014
- Last updated
- 22 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acetabular Bone Vascularity in Metal-on-Metal Revisions
- ClinicalTrials.gov ID
- NCT02239406
- Acronym / sponsor ID
- HK025
- Conditions
- Failure of Total Hip
- Keywords
- metal on metal total hip, avasuclar necrosis, acetabular revision, bone vascularity
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of enrollment interest.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- OrthoCarolina Research Institute, Inc.University, hospital or other
- Collaborators
- Presbyterian Pathology Group
- Study start
- Nov 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 12 Sep 2014 (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.
The purpose of this study is to determine if avascular necrosis of the acetabulum is present in metal-on-metal revisions and to what depth this dead avascular bone occurs.
A convenient sample of a consecutive series of 15 patients treated for metal on metal acetabular revision surgery will be included.
Detailed description
Patients being treated for metal on metal acetabular revision surgery by a physician at OrthoCarolina, PA will be screened for eligibility. These patients will be approached by their surgeon and asked to volunteer their participation in the study. Potential subjects will meet with a research coordinator to discuss details of the study and those you volunteer participation will be asked to sign an informed consent prior to the collection of study data. . Basic demographic information (initials, age, gender, height, weight, BMI), dates of original index surgery, reason for revision, type of implant being removed, and standard of care cobalt and chromium metal ion levels will be collected via chart review.
Patients who meet all eligibility criteria will have three biopsies performed at the time of their revision surgery. A pathologist will note the presence or absence of bone necrosis and will measure the length (mm) of necrosis, acute inflammation, chronic inflammation, normal bone, and entire bone specimen in order to obtain a ratio.
Biopsy Protocol:
A bone biopsy is a procedure in which bone samples are removed (with a special instrument during surgery) and looked at under a microscope for necrosis (tissue death), infection, or other bone disorders. Once the acetabular hip replacement implants have been removed the following steps will occur:
- The biopsy needle will be inserted into the bone (3 locations; 2 from ilium, 1 from pubis or ischium = 3 total).
- The biopsy needle will be withdrawn and firm pressure will be applied to the biopsy site for a few minutes, until the bleeding has stopped.
- Each bone biopsy sample will be labeled sequentially and by anatomic location (i.e., ilium #1, ilium #2)
- The normal bone will be marked on the bone sample.
- The bone biopsy sample will be sent to the lab for examination.
- The acetabulum bone will be reamed so the new implant can be seated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metal-on-Metal Revision | – | –Patients who have a failed metal on metal total hip implant and are presenting for revision surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A convenience sample of a total of 15 patients will be enrolled at OrthoCarolina.
Key inclusion criteria (5 listed)
- Patients being revised for an aseptic metal on metal acetabular revision.
- Patient is greater than one year postoperative.
- Patient has had cobalt and chromium metal ion levels tested within 6 months of the planned revision surgery.
- Understands the local language and is willing and able to follow the requirements of the protocol.
- Understands the informed consent and signs the institutional review board or independent ethics committee (IRB/IEC) approved informed consent form.
Key exclusion criteria (4 listed)
- History of infection
- Evidence of current substance or alcohol abuse
- Being treated with radiation, chemotherapy, immunosupression, or chronic steroid therapy (prednisone use up to 5 mg/qd or its equivalent is allowed)
- Is a prisoner
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
The depth (mm) of avascular bone from the acetabular surface per each patient
Time frame: participants will be followed for the duration of their surgery, an expected average of 2 hours
A bone biopsy is a procedure in which bone samples are removed (with a special instrument during surgery) and looked at under a microscope for necrosis (tissue death), infection, or other bone disorders. Once the acetabular hip replacement implants have been removed the following steps will occur: * The biopsy needle will be inserted into the bone (3 locations; 2 from ilium, 1 from pubis or ischium = 3 total). * The biopsy needle will be withdrawn and firm pressure will be applied to the biopsy site for a few minutes, until the bleeding has stopped. * Each bone biopsy sample will be labeled sequentially and by anatomic location (i.e., ilium #1, ilium #2) * The normal bone will be marked on the bone sample. * The bone biopsy sample will be sent to the lab for examination.
1 secondary outcome
The ratio of necrotic bone per each patient
Time frame: paricipants will be followed for the duration of their surgery, an expected average of 2 hours
Results and safety
The study was stopped early (reason given: Lack of enrollment interest.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2016.
- Individual participant dataSharing planned: No
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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.
Thomas Fehring, MD principal investigator
OrthoCarolina Research Institute, Inc.
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 Failure of Total Hip, run by OrthoCarolina Research Institute, Inc. 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 5 inclusion and 4 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 22 Jul 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 (reason given: Lack of enrollment interest.). 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?
The depth (mm) of avascular bone from the acetabular surface per each patient (time frame: participants will be followed for the duration of their surgery, an expected average of 2 hours). 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 22 Jul 2016.