SpondylolisthesisNCT00791180
Posterior Lateral Fusion (PLF) With Dynesys
An observational study of Spondylolisthesis, run by Zimmer Biomet at 1 site in United States.
Trial summary
The primary purpose of this study is to track and document the clinical outcomes of patients with radicular pathology following posterior lateral fusion with the Dynesys Spinal System. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Spondylolisthesis
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Mar 2011
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinical outcomes following postierior lateral fusion with the Dynesys(R) Spinal System
Who may be able to join
- Spondylolisthesis of less than Grade II at the index level (degenerative with intact pars)
- Will receive a decompression for lumbar stenosis
- Symptoms of leg and/or back pain
- One pathological level
- Between the ages of 20 and 80 at the time of surgery
- Non-responsive to non-surgical treatment for at least six months
Who cannot join
- Osteolytic spondylolisthesis
- Planned complete facetectomy
- Two or more pathological levels (and as enumerated int he Dynesys Spinal system instructions for use)
- Use in the cervical spine
- Active systemic or local infection
- Extreme obesity as defined by a Body Mass Index (BMI)over 40. BMI calculated using Appendix A, adapted from the National Heart, Lung, and Blood Institute, Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults.
Show all 16Show fewer
- Pregnancy
- Mental illness
- Severe osteoporosis or osteopenia. The World Health Organization defines osteoporosis as BMD<-2.5t. Professional discretion should be used and if bone quality is in question a DEXA scan is recommended.
- Sensitivities/allergy to metals, polymers, polyethylene, polycarbonate urethane and polyethylene terephthalate
- Alcohol or drug abuse
- Patient unwilling or unable to follow postoperative instructions
- Soft tissue deficit not allowing sound closure
- Any medical or physical condition that would preclude the potential benefit of spinal surgery
- Inadequate pedicles of the lumbar or sacral vertebrae; congenital abnormalities, tumors or other conditions that would prevent secure component fixation that has the potential to decrease the useful life of othe devices;
- Any medical or mental condition which would exclude the patient at high risk from surgery of the severity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcomes Following Posterior Lateral Fusion With the Dynesys(R) Spinal System
The primary purpose of this study is to track and document the clinical outcomes of patients with radicular pathology following posterior lateral fusion with the Dynesys Spinal System. Secondary purpose of this study is to assess outcomes with historical controls along a continuum of motion and anatomy sparing procedures.
Read the detailed description
This study will help the patient to the extent that it will allow the comparison of this unique treatment to the corpus of literature on radicular pathology, thus focusing a specific treatment for a specific pathology.
- Conditions
- Spondylolisthesis
- Keywords
- dynamic stabilization, Dynesys, fusion success, Immobilization of spinal segments as an adjunct to fusion in the treatment of the following:, acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine, degenerative spondylolisthesis with objective evidence of neurologic impairment, failed previous fusion (pseudarthrosis).
- Medical subject headings
- Spondylolisthesis, Pseudarthrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Outcomes
Measured: Pre-op, Surgery, 3 month, 6 month, 12 months and 24 months
Secondary outcomes (1)
Surgical Outcomes
Measured: Pre-op, Surgery, 3 months, 6 months, 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2008 (estimated)
- Study startMar 2006
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondylolisthesisStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jozef Murar, M.D., Study director, Zimmer Spine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00791180
- Sponsor's protocol ID
- 2006-002
- Status last verified
- Sep 2011
- First submitted
- 13 Nov 2008
- Last updated
- 29 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes Following Posterior Lateral Fusion With the Dynesys(R) Spinal System
- ClinicalTrials.gov ID
- NCT00791180
- Acronym / sponsor ID
- 2006-002
- Conditions
- Spondylolisthesis
- Keywords
- dynamic stabilization, Dynesys, fusion success, Immobilization of spinal segments as an adjunct to fusion in the treatment of the following:, acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine, degenerative spondylolisthesis with objective evidence of neurologic impairment, failed previous fusion (pseudarthrosis).
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 14 Nov 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.
The primary purpose of this study is to track and document the clinical outcomes of patients with radicular pathology following posterior lateral fusion with the Dynesys Spinal System. Secondary purpose of this study is to assess outcomes with historical controls along a continuum of motion and anatomy sparing procedures.
Detailed description
This study will help the patient to the extent that it will allow the comparison of this unique treatment to the corpus of literature on radicular pathology, thus focusing a specific treatment for a specific pathology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinical outcomes following postierior lateral fusion with the Dynesys(R) Spinal System
Key inclusion criteria (6 listed)
- Spondylolisthesis of less than Grade II at the index level (degenerative with intact pars)
- Will receive a decompression for lumbar stenosis
- Symptoms of leg and/or back pain
- One pathological level
- Between the ages of 20 and 80 at the time of surgery
Key exclusion criteria (16 listed)
- Osteolytic spondylolisthesis
- Planned complete facetectomy
- Two or more pathological levels (and as enumerated int he Dynesys Spinal system instructions for use)
- Use in the cervical spine
- Active systemic or local infection
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
Clinical Outcomes
Time frame: Pre-op, Surgery, 3 month, 6 month, 12 months and 24 months
1 secondary outcome
Surgical Outcomes
Time frame: Pre-op, Surgery, 3 months, 6 months, 12 months and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2011.
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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.
Jozef Murar, M.D. study director
Zimmer Spine
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 Spondylolisthesis, 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 6 inclusion and 16 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: finished, as of the sponsor's last update on 29 Sep 2011. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical Outcomes (time frame: Pre-op, Surgery, 3 month, 6 month, 12 months and 24 months). 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 29 Sep 2011.