Degenerative Spondylolisthesis or RetrolisthesisPhase 3NCT00759057
A Clinical Study of the Dynesys(R) Spinal System
A Phase 3 study testing Posterior Pedicle Screw System in people with Degenerative Spondylolisthesis or Retrolisthesis and Spinal Stenosis, run by Zimmer Biomet at 26 sites in United States.
Trial summary
This non-inferiority study will compare the clinical outcomes of subjects implanted with the Dynesys Spinal System versus the clinical outcomes of subjects implanted with an instrumented posterior lateral spinal fusion. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Degenerative Spondylolisthesis or Retrolisthesis, Spinal Stenosis, Stenosing Lesion.
- What is being tested?
- Posterior Pedicle Screw System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 399 participants
- Where
- 26 sitesUnited States
- Study dates
- Mar 2003to Dec 2015
- Phase
- Phase 3
- 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
Who may be able to join
- Patients having degenerative spondylolisthesis or retrolisthesis (up to Grade 1) AND/OR Patients having lateral or central spinal stenosis or other stenosing lesion as diagnosed by radiculopathic signs, neurogenic claudication or imaging studies;
- Candidate for single-level or contiguous two-level PLF between L1-S1;
- Patients have a predominate component of leg rather than back symptoms; symptoms include pain, muscle weakness, and/or sensation abnormality as evidenced by patient history and diagnostic studies.
- Patients may require decompression at the levels considered for treatment
- Pre-operative leg pain score greater than or equal to 40 mm on a 100 mm Visual Analog Scale (VAS);
- Leg pain must be unresponsive to conservative (non-surgical) management for minimum of 3 months;
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- Pre-operative Oswestry score greater than or equal to 30 indicating at least moderate disability;
- Skeletally mature individual between ages 20 and 80;
- Must be willing and able to comply with study requirements; including willing and able to sign a study-specific, IRB-approved informed consent form, complete necessary study paperwork and return for required follow-up visits.
Who cannot join
- Primary diagnosis of discogenic back pain at affected levels as evidenced by a larger back than leg pain component. In the event of multi-level pathology a discogram should be considered;
- Patients with leg pain due to etiologies other than those listed above, such as trauma, peripheral vascular disease and neuropathy should be excluded;
- Degenerative scoliosis greater than 10 degrees at the affected motion segment;
- Supplemental interbody column support (e.g., bone graft, spacers or fusion cages) is planned at the affected level(s);
- Greater than Grade I spondylolisthesis or retrolisthesis at the affected level(s);
- Radiculopathic signs from more than two contiguous or two noncontiguous vertebral body segment(s);
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- Previous lumbar fusion attempt(s), previous total facetectomy or trauma at the affected level(s);
- Gross obesity defined as exceeding ideal weight by greater than 40% (measurement details are given in Appendix A);
- Active local or systemic infection;
- Advanced osteoporosis as evidenced by plain film radiographs or history of fractures and confirmed by DEXA scan to confirm adequate bone density;
- Receiving immunosuppressive or long-term steroid therapy;
- Active hepatitis (viral or serum) or HIV positive, renal failure, systemic lupus erythematosus, or any other significant medical conditions which would substantially increase the risk of surgery;
- Documented history of titanium alloy, PET or PCU allergy, or intolerance;
- Active malignancy or other significant medical comorbidities;
- Current chemical dependency or significant emotional and/or psychosocial disturbance that may impact treatment outcome or study participation as evidenced by three or more positive Waddell Signs;
- Pregnancy;
- Incarceration;
- Severe muscular, neural or vascular diseases that endanger the spinal column;
- Missing bone structures, due to severely deformed anatomy or congenital anomalies, which make good anchorage of the implant impossible;
- All concomitant diseases that can jeopardize the functioning and success of the patient;
- Vertebral fractures;
- Treatment of the thoracic and cervical spine;
- Severely deformed anatomy due to congenital anomalies;
- Paralysis
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Peachtree Orthopaedic Clinic
Atlanta, Georgia, 30342
Orthopedic Care & Sports Medicine Center
Aventura, Florida, 33180
Baltimore Neurosurgical Associates, PA
Baltimore, Maryland, 21204
Spine Specialty Center (SSC)
Baton Rouge, Louisiana, 70810
College Station Neurosurgery
College Station, Texas, 77845
Denver Spine Center
Denver, Colorado, 80218
Triangle Orthopedic Associates
Durham, North Carolina, 27704
Orthopedic Consultants, PA
Edina, Minnesota, 55435
Orthopaedic Spine Associates
Eugene, Oregon, 97401
Fort Wayne Orthopedic
Fort Wayne, Indiana, 46804
Park Plaza Hospital
Houston, Texas, 77004
Indiana University Neurosurgical
Indianapolis, Indiana, 46202
Cedars-Sinai Medical Center, The Spine Institute
Los Angeles, California, 90048
Pacific Regional Neurosurgery
Modesto, California, 95350
SPINE
Mt. Pleasant, South Carolina, 29464
Manhattan Orthopaedics, PC
New York, New York, 10021
Heartland Spine and Hand Center
Overland Park, Kansas, 66211
Sports Medicine North
Peabody, Massachusetts, 01960
Dept. of Neurosurgery UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213-2582
SpineMark CRO at TBI
Plano, Texas, 75093
Scottsdale Spine Center
Scottsdale, Arizona, 85251
SUNY Upstate Medical University Dept of Orthopedic Surgery
Syracuse, New York, 13202
Orthopaedic Associates
Towson, Maryland, 21204
Northwest NeuroSpecialists
Tucson, Arizona, 85741
Medical Faculty Associates - The George Washington University
Washington D.C., District of Columbia, 20037
Abington Hospital
Willow Grove, Pennsylvania, 19090
About this study
Official title: A Clinical Study of the Dynesys(R) Spinal System As a Non-fusion Device for Spinal Stabilization
This non-inferiority study will compare the clinical outcomes of subjects implanted with the Dynesys Spinal System versus the clinical outcomes of subjects implanted with an instrumented posterior lateral spinal fusion.
Read the detailed description
The purpose of this clinical study is to demonstrate the safety and effectiveness of the Dynesys Spinal System for patients requiring one or contiguous two-level posterior spinal stabilization of the lumbar, and/or sacral spine following decompression. The ability for this implant to maintain spinal alignment and non-fusion of spinal segments, while positively affecting clinical outcomes, will be assessed and compared to a posterior lateral spinal fusion (PLF) procedure using autogenous bone with a semi-rigid, polyaxial posterior spinal fixation system.
- Being tested
- Posterior Pedicle Screw System
- Keywords
- Spinal Stenosis, Spinal Instability, Leg Pain
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior Pedicle Screw SystemDevice
Implantation of Posterior Pedicle Screw System
| Study group | Role | What they receive |
|---|---|---|
| 1 - Investigational | Experimental | Dynesys Non-Fusion Spinal System Receives: Device: Posterior Pedicle Screw System |
| 2 - Control | Active comparator | Silhouette Posterior Pedicle Screw System as an adjunct to Posterior Lateral Fusion with Autograft. Receives: Device: Posterior Pedicle Screw System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Clinical Success (VAS Leg Pain, ODI, Major Complications, Additional Surgical Procedures, Neurological Status)
Measured: 24 Months
Secondary outcomes (1)
Radiographic Success, SF-12, Back Pain, Economic and Function Assessment, Subject Perception
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startMar 2003
- Primary completionJun 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: PMA not approved. FDA granted permission to close the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Spondylolisthesis or RetrolisthesisStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 399 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
- NCT00759057
- Sponsor's protocol ID
- G020291
- Status last verified
- Jun 2012
- First submitted
- 23 Sep 2008
- Last updated
- 28 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of the Dynesys(R) Spinal System As a Non-fusion Device for Spinal Stabilization
- ClinicalTrials.gov ID
- NCT00759057
- Acronym / sponsor ID
- G020291
- Keywords
- Spinal Stenosis, Spinal Instability, Leg Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PMA not approved. FDA granted permission to close the study.
- Enrolment
- 399 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 25 Sep 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.
This non-inferiority study will compare the clinical outcomes of subjects implanted with the Dynesys Spinal System versus the clinical outcomes of subjects implanted with an instrumented posterior lateral spinal fusion.
Detailed description
The purpose of this clinical study is to demonstrate the safety and effectiveness of the Dynesys Spinal System for patients requiring one or contiguous two-level posterior spinal stabilization of the lumbar, and/or sacral spine following decompression. The ability for this implant to maintain spinal alignment and non-fusion of spinal segments, while positively affecting clinical outcomes, will be assessed and compared to a posterior lateral spinal fusion (PLF) procedure using autogenous bone with a semi-rigid, polyaxial posterior spinal fixation system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 - Investigational | Experimental | Device: Posterior Pedicle Screw SystemDynesys Non-Fusion Spinal System |
| 2 - Control | Active comparator | Device: Posterior Pedicle Screw SystemSilhouette Posterior Pedicle Screw System as an adjunct to Posterior Lateral Fusion with Autograft. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients having degenerative spondylolisthesis or retrolisthesis (up to Grade 1) AND/OR Patients having lateral or central spinal stenosis or other stenosing lesion as diagnosed by radiculopathic signs, neurogenic claudication or imaging studies;
- Candidate for single-level or contiguous two-level PLF between L1-S1;
- Patients have a predominate component of leg rather than back symptoms; symptoms include pain, muscle weakness, and/or sensation abnormality as evidenced by patient history and diagnostic studies.
- Patients may require decompression at the levels considered for treatment
- Pre-operative leg pain score greater than or equal to 40 mm on a 100 mm Visual Analog Scale (VAS);
Key exclusion criteria (24 listed)
- Primary diagnosis of discogenic back pain at affected levels as evidenced by a larger back than leg pain component. In the event of multi-level pathology a discogram should be considered;
- Patients with leg pain due to etiologies other than those listed above, such as trauma, peripheral vascular disease and neuropathy should be excluded;
- Degenerative scoliosis greater than 10 degrees at the affected motion segment;
- Supplemental interbody column support (e.g., bone graft, spacers or fusion cages) is planned at the affected level(s);
- Greater than Grade I spondylolisthesis or retrolisthesis at the affected level(s);
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 |
|---|---|---|
| Posterior Pedicle Screw SystemImplantation of Posterior Pedicle Screw System | Device | 1 - Investigational, 2 - Control |
Primary outcome
Overall Clinical Success (VAS Leg Pain, ODI, Major Complications, Additional Surgical Procedures, Neurological Status)
Time frame: 24 Months
1 secondary outcome
Radiographic Success, SF-12, Back Pain, Economic and Function Assessment, Subject Perception
Time frame: 24 Months
Results and safety
The study was stopped early (reason given: PMA not approved. FDA granted permission to close the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2012.
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.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Posterior Pedicle Screw System in people with Degenerative Spondylolisthesis or Retrolisthesis and Spinal Stenosis, run by Zimmer Biomet at 26 sites 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 9 inclusion and 24 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 28 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: PMA not approved. FDA granted permission to close the study.). 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?
Overall Clinical Success (VAS Leg Pain, ODI, Major Complications, Additional Surgical Procedures, Neurological Status) (time frame: 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 28 Jun 2012.