Degenerative Disc DiseaseNCT00726310
Evaluation Of Spinelink® Fixation In The Treatment Of Degenerative Spondylolisthesis And Spinal Instability
An observational study of Degenerative Disc Disease and Degenerative Spondylolisthesis, run by Zimmer Biomet at 2 sites in United States.
Trial summary
The purpose of this open, multi-center study is to prospectively collect outcome data on patients who are having lumbar spinal fusion surgery with implantation of the SpineLink® system. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Degenerative Disc Disease, Degenerative Spondylolisthesis
- What is being tested?
- SpineLink® , SpineLink® II
- Type of treatment
- Medical device
- How many people
- 202 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2000to Nov 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Multiple site around the US
Who may be able to join
- The patient has demonstrated Grade I or Grade II degenerative spondylolisthesis exhibited by maximum slippage on flexion and extension radiographs with symptoms that include back pain and/or leg pain with spinal fusion indicated, or spinal instability as evidenced by greater than 3 mm of translational motion or greater than 10 degrees of angular motion between the involved vertebrae as evidenced by flexion-extension radiographs.
- This surgery will be the primary fusion attempt with no more than three (3) vertebrae or 2 disc spaces involved.
- The patient must be available for yearly follow-up in the study until completion of the 24 month evaluation.
- The patient must be skeletally mature (epiphyses closed).
- Bone grafting material must be limited to autograft and/or bone-bank allograft.
- The patient must be willing to comply with the treatment regimen, follow-up requirements, and have the legal ability to give informed consent.
Who cannot join
- Patients with supplemental spinal internal fixation devices previously implanted at any other level and/or a previous fusion attempt at the involved level(s) (no interbody fusions, salvage procedures, or prior hardware).
- Patients with other pathology at the involved spinal level, e.g., osteomyelitis, Paget's disease, pathologic fracture, etc.
- Patients with a disease entity or condition that totally precludes the possibility of bony fusion such as known active cancer, etc.
- Patients who have significant metabolic diseases including insulin dependent diabetes, renal dysfunction, etc.
- Patients involved in personal injury litigation.
- Pregnant or nursing females.
- Patient in whom unapproved biologicals (e.g. BMP-2) or bone substitute materials (e.g. Grafton) would be used at the fusion site.
- Patients who are unable to understand and sign an informed consent or who, in the opinion of the investigator, would be psychologically unwilling or unable to understand or complete the protocol, especially those unwilling or unable to participate in the follow-up.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rogozinski Orthopedic Clinic
Jacksonville, Florida, 32216
Alvarado Orthopedic Clinic
San Diego, California, 92120
About this study
Official title: A Multicenter Prospective Patient Outcome Evaluation Of Spinelink® Fixation In The Treatment Of Degenerative Spondylolisthesis And Spinal Instability
The purpose of this open, multi-center study is to prospectively collect outcome data on patients who are having lumbar spinal fusion surgery with implantation of the SpineLink® system.
Read the detailed description
This will be an open, prospective, multi-center outcome study. This study will be conducted at up to ten centers, each of which will enroll approximately 20 patients. A maximum of 200 patients will be enrolled. This patient sample size will allow statistical comparison to historical literature and allow an inter-center comparison of outcome. Enrollment into the study may include all patients who have lumbar spinal fusion performed. All spinal fusion surgery will be performed using the EBI SpineLink® system.
- Being tested
- SpineLink® , SpineLink® II
- Keywords
- Spondylolisthesis, Instability
- Medical subject headings
- Intervertebral Disc Degeneration, Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpineLink® , SpineLink® IIDevice
Spine plate system for lumbar spinal fusions
| Study group | Role | What they receive |
|---|---|---|
| SpineLink® , SpineLink® II Group | Spinal fusion surgery with SpineLink® Receives: Device: SpineLink® , SpineLink® II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of successful fusions achieved
AP radiographs will be evaluated for the evidence of bridging virgin trabecular bone across the fusion mass. In order for a patient to be considered fused, A/P radiographs must show evidence of bridging virgin trabecular bone across the fusion mass.
Measured: 24 Months
Secondary outcomes (3)
Neurologic Assessment
Maintenance or Improvement
Measured: 24 Months
Radiographic Fusion Grade
Radiographic fusion grade will be assessed at each follow up, as defined by Dawson et al. 8, as follows: A0 = Pseudarthrosis A1 = Unilateral Pseudarthrosis A2 = Insufficient Unilateral Bone Mass A3 = Contiguous Fusion without Hypertrophy A4 = Solid Fusion with Hypertrophy of Fusion Mass
Measured: 24 Months
SF-36 Health Survey
Health Survey
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 posted31 Jul 2008 (estimated)
- Study startMay 2000
- Primary completionJul 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 202 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
- NCT00726310
- Sponsor's protocol ID
- CS-044
- Status last verified
- Feb 2020
- First submitted
- 29 Jul 2008
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Patient Outcome Evaluation Of Spinelink® Fixation In The Treatment Of Degenerative Spondylolisthesis And Spinal Instability
- ClinicalTrials.gov ID
- NCT00726310
- Acronym / sponsor ID
- CS-044
- Keywords
- Spondylolisthesis, Instability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- May 2000
- Primary completion
- Jul 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 31 Jul 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 purpose of this open, multi-center study is to prospectively collect outcome data on patients who are having lumbar spinal fusion surgery with implantation of the SpineLink® system.
Detailed description
This will be an open, prospective, multi-center outcome study. This study will be conducted at up to ten centers, each of which will enroll approximately 20 patients. A maximum of 200 patients will be enrolled. This patient sample size will allow statistical comparison to historical literature and allow an inter-center comparison of outcome. Enrollment into the study may include all patients who have lumbar spinal fusion performed. All spinal fusion surgery will be performed using the EBI SpineLink® system.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SpineLink® , SpineLink® II Group | – | Device: SpineLink® , SpineLink® IISpinal fusion surgery with SpineLink® |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Multiple site around the US
Key inclusion criteria (6 listed)
- The patient has demonstrated Grade I or Grade II degenerative spondylolisthesis exhibited by maximum slippage on flexion and extension radiographs with symptoms that include back pain and/or leg pain with spinal fusion indicated, or spinal instability as evidenced by greater than 3 mm of translational motion or greater than 10 degrees of angular motion between the involved vertebrae as evidenced by flexion-extension radiographs.
- This surgery will be the primary fusion attempt with no more than three (3) vertebrae or 2 disc spaces involved.
- The patient must be available for yearly follow-up in the study until completion of the 24 month evaluation.
- The patient must be skeletally mature (epiphyses closed).
- Bone grafting material must be limited to autograft and/or bone-bank allograft.
Key exclusion criteria (8 listed)
- Patients with supplemental spinal internal fixation devices previously implanted at any other level and/or a previous fusion attempt at the involved level(s) (no interbody fusions, salvage procedures, or prior hardware).
- Patients with other pathology at the involved spinal level, e.g., osteomyelitis, Paget's disease, pathologic fracture, etc.
- Patients with a disease entity or condition that totally precludes the possibility of bony fusion such as known active cancer, etc.
- Patients who have significant metabolic diseases including insulin dependent diabetes, renal dysfunction, etc.
- Patients involved in personal injury litigation.
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 |
|---|---|---|
| SpineLink® , SpineLink® IISpine plate system for lumbar spinal fusions | Device | SpineLink® , SpineLink® II Group |
Primary outcome
Percentage of successful fusions achieved
Time frame: 24 Months
AP radiographs will be evaluated for the evidence of bridging virgin trabecular bone across the fusion mass. In order for a patient to be considered fused, A/P radiographs must show evidence of bridging virgin trabecular bone across the fusion mass.
3 secondary outcomes
Neurologic Assessment
Time frame: 24 Months
Radiographic Fusion Grade
Time frame: 24 Months
SF-36 Health Survey
Time frame: 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 13 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease and Degenerative Spondylolisthesis, run by Zimmer Biomet at 2 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 6 inclusion and 8 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 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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?
Percentage of successful fusions achieved (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 13 Feb 2020.