Assess Motion in Flexion/Extension and Lateral Bending of the Lumbar Vertebrae in Vivo Following Motion Sparing Surgery Using Radiostereometric Analysis (RSA.)NCT00634465
A Biomechanical Assessment of the AST Stabilimax BAR Using Radiostereometric Analysis (RSA)
An observational study of Assess Motion in Flexion/Extension and Lateral Bending of the Lumbar Vertebrae in Vivo Following Motion Sparing Surgery Using Radiostereometric Analysis (RSA.), run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
Assessment of segmental spine motion has been and continues to be, a difficult clinical problem. Errors of up to 10 degrees for simple measurements of flexion, extension and side bending have been recorded using conventional radiographs (xrays.) These errors are usually associated with the inability to acquire… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Assess Motion in Flexion/Extension and Lateral Bending of the Lumbar Vertebrae in Vivo Following Motion Sparing Surgery Using Radiostereometric Analysis (RSA.)
- What is being tested?
- RSA Beads
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Oct 2008
- 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
- No healthy volunteers
- Adult, Older adult
Study population: This is a single-center, non-randomized study. 10 Subjects who are identified to receive the AST Stabilimax BAR device will be approached to participate in this study. All subjects will receive 10 RSA tantalum beads (5 in each vertebra) at the time of their lumbar surgery. After surgery, subjects will have the biplanar xrays taken. The biplanar xrays will be taken from 5 standing positions: neutral, flexion (bending forward), extension (bending backwards), left side bending, and right side bending. RSA analysis will be completed to determine the amount of motion on sagittal and coronal planes.
Who may be able to join
- Subjects scheduled to have lumbar surgery to receive the AST Stabilimax BAR
- All subjects must be skeletally mature, between the ages of 18-75
Who cannot join
- Pregnant women will be excluded due to added radiation exposure
- Prisoners will also be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical University
Syracuse, New York, 13202
About this study
Assessment of segmental spine motion has been and continues to be, a difficult clinical problem. Errors of up to 10 degrees for simple measurements of flexion, extension and side bending have been recorded using conventional radiographs (xrays.) These errors are usually associated with the inability to acquire three-dimensional positions and inaccurate reference points. It has, therefore, been extremely difficult to measure small changes in vertebral alignment, which may prove to be an early, clinically significant, indicator of potential problems. Radiostereometric Analysis, or RSA, is an accurate in vivo measurement technique using two simultaneous radiographs. It provides researchers with three dimensional motion analyses to look not only at routine flexion/extension, but also other rotational and translational changes. The measurement accuracy offered by this technique far exceeds the manual techniques currently used. The purpose of this study is to assess the amount of motion in the lumbar spine in patients with the AST Stabilimax BAR. The AST Stabilimax BAR is designed to allow for motion in the spine while providing the necessary stability to the spinal segment. The amount and degree of this motion is currently unknown clinically. By using tantalum bead markers placed in the spine at the time of the surgery, RSA analysis can determine the amount and degree of motion of the implanted construct. Two questions will be examined with this data: 1) what is the amount of sagittal and coronal plane motion that occurs in vivo with the AST Stabilimax BAR system? and 2) will this change over the 2 year time frame for this study?
Read the detailed description
Radiostereometric Analysis, or RSA, is an accurate in vivo measurement technique using two simultaneous radiographs. It provides researchers with three dimensional motion analyses to look not only at routine flexion/extension, but also other rotational and translational changes. The measurement accuracy offered by this technique far exceeds the manual techniques currently used. Utilization of the RSA technology at the IHP and the United States is in its infancy. The investigators have placed much effort over the past 2-3 years to put the necessary dedicated resources and personnel in place. This has been a collaborative effort between the Department of Orthopedic Surgery and the Imaging Core at IHP. Preliminary work on the accuracy, reliability, and surgical planning for use of RSA has been completed and presented at national conferences.
The purpose of this study is to assess the amount of motion in the lumbar spine in patients with the AST Stabilimax BAR. The AST Stabilimax BAR is designed to allow for motion in the spine while providing the necessary stability to the spinal segment. The amount and degree of this motion is currently unknown clinically, but has been biomechanically tested in vitro. By using tantalum bead markers placed in the spine at the time of the surgery, RSA analysis can determine the amount and degree of motion the implant provides. Two questions will be examined with this data: 1) what is the amount of sagittal and coronal plane motion that occurs in vivo with the AST Stabilimax BAR system? and 2) will this change over the 2 year time frame for this study?
- Being tested
- RSA Beads
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSA BeadsDevice
Radiostereometric Analysis, or RSA, is an accurate in vivo measurement technique using two simultaneous radiographs. It provides researchers with three dimensional motion analyses to look not only at routine flexion/extension, but also other rotational and translational changes
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Device: RSA Beads |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startOct 2006
- Primary completionOct 2008
- Study completionOct 2008
Why it stopped: low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assess Motion in Flexion/Extension and Lateral Bending of the Lumbar Vertebrae in Vivo Following Motion Sparing Surgery Using Radiostereometric Analysis (RSA.)Studies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00634465
- Sponsor's protocol ID
- Stabilimax Bar
- Status last verified
- May 2015
- First submitted
- 4 Mar 2008
- Last updated
- 25 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Biomechanical Assessment of the AST Stabilimax BAR Using Radiostereometric Analysis (RSA)
- ClinicalTrials.gov ID
- NCT00634465
- Acronym / sponsor ID
- Stabilimax Bar
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: low enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 13 Mar 2008 (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.
Assessment of segmental spine motion has been and continues to be, a difficult clinical problem. Errors of up to 10 degrees for simple measurements of flexion, extension and side bending have been recorded using conventional radiographs (xrays.) These errors are usually associated with the inability to acquire three-dimensional positions and inaccurate reference points. It has, therefore, been extremely difficult to measure small changes in vertebral alignment, which may prove to be an early, clinically significant, indicator of potential problems. Radiostereometric Analysis, or RSA, is an accurate in vivo measurement technique using two simultaneous radiographs. It provides researchers with three dimensional motion analyses to look not only at routine flexion/extension, but also other rotational and translational changes. The measurement accuracy offered by this technique far exceeds the manual techniques currently used. The purpose of this study is to assess the amount of motion in the lumbar spine in patients with the AST Stabilimax BAR. The AST Stabilimax BAR is designed to allow for motion in the spine while providing the necessary stability to the spinal segment. The amount and degree of this motion is currently unknown clinically. By using tantalum bead markers placed in the spine at the time of the surgery, RSA analysis can determine the amount and degree of motion of the implanted construct. Two questions will be examined with this data: 1) what is the amount of sagittal and coronal plane motion that occurs in vivo with the AST Stabilimax BAR system? and 2) will this change over the 2 year time frame for this study?
Detailed description
Radiostereometric Analysis, or RSA, is an accurate in vivo measurement technique using two simultaneous radiographs. It provides researchers with three dimensional motion analyses to look not only at routine flexion/extension, but also other rotational and translational changes. The measurement accuracy offered by this technique far exceeds the manual techniques currently used. Utilization of the RSA technology at the IHP and the United States is in its infancy. The investigators have placed much effort over the past 2-3 years to put the necessary dedicated resources and personnel in place. This has been a collaborative effort between the Department of Orthopedic Surgery and the Imaging Core at IHP. Preliminary work on the accuracy, reliability, and surgical planning for use of RSA has been completed and presented at national conferences.
The purpose of this study is to assess the amount of motion in the lumbar spine in patients with the AST Stabilimax BAR. The AST Stabilimax BAR is designed to allow for motion in the spine while providing the necessary stability to the spinal segment. The amount and degree of this motion is currently unknown clinically, but has been biomechanically tested in vitro. By using tantalum bead markers placed in the spine at the time of the surgery, RSA analysis can determine the amount and degree of motion the implant provides. Two questions will be examined with this data: 1) what is the amount of sagittal and coronal plane motion that occurs in vivo with the AST Stabilimax BAR system? and 2) will this change over the 2 year time frame for this study?
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: RSA Beads |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a single-center, non-randomized study. 10 Subjects who are identified to receive the AST Stabilimax BAR device will be approached to participate in this study. All subjects will receive 10 RSA tantalum beads (5 in each vertebra) at the time of their lumbar surgery. After surgery, subjects will have the biplanar xrays taken. The biplanar xrays will be taken from 5 standing positions: neutral, flexion (bending forward), extension (bending backwards), left side bending, and right side bending. RSA analysis will be completed to determine the amount of motion on sagittal and coronal planes.
Key inclusion criteria (2 listed)
- Subjects scheduled to have lumbar surgery to receive the AST Stabilimax BAR
- All subjects must be skeletally mature, between the ages of 18-75
Key exclusion criteria (2 listed)
- Pregnant women will be excluded due to added radiation exposure
- Prisoners will also be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RSA BeadsRadiostereometric Analysis, or RSA, is an accurate in vivo measurement technique using two simultaneous radiographs. It provides researchers with three dimensional motion analyses to look not only at routine flexion/extension, but also other rotational and translational changes | Device | 1 |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2015.
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 Assess Motion in Flexion/Extension and Lateral Bending of the Lumbar Vertebrae in Vivo Following Motion Sparing Surgery Using Radiostereometric Analysis (RSA.), run by State University of New York - Upstate Medical University 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 2 inclusion and 2 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: withdrawn, as of the sponsor's last update on 25 May 2015. 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 withdrawn before enrolling participants, so there are no results.
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.
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 25 May 2015.