Degenerative Disc DiseaseNCT01016314
Efficacy of the Aspen Spinous Process System in Anterior Lumbar Interbody Fusion (ALIF)
A study testing Aspen Spinous Process System and Pedicle Screw Fixation in people with Degenerative Disc Disease, run by Zimmer Biomet at 5 sites in United States.
Trial summary
This is a multi-center, prospective randomized clinical study to evaluate the clinical outcome of subjects with degenerative disc disease (DDD) treated with ALIF and supplemental posterior fixation using ASPEN Spinous Process System compared to pedicle screw instrumentation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- Aspen Spinous Process System and Pedicle Screw Fixation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2009to Jan 2016
- Phase
- Interventional
- 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
Who may be able to join
- Age between 18 and 75 years
- Scheduled for an elective single level ALIF with posterior fixation
- Diagnosis of primary symptomatic DDD confirmed with appropriate imaging studies and/or positive lumbar discography
- Oswestry Disability Index (ODI) v 2.1 score >30%
- Failed at least 6 weeks of conservative care (non-surgical)/clinical signs of neurological deterioration
- No contraindications for ASPEN spinous process system (at the discretion of the investigator)
Who cannot join
- Prior lumbar fusion surgery at any level (prior discectomy and/or laminectomy allowed)
- Spondylolisthesis grade 3 or more
- Lytic spondylolisthesis
- Incompetent or missing posterior arch at the affected level (e.g. laminectomy, pars defect)
- Currently requires laminectomy at level of surgery
- Facet joints at implant level are absent or fractured
Show all 21Show fewer
- Post-traumatic vertebral body compromise or acute fracture at implant level
- Body mass Index (BMI) > 40
- Known allergy to titanium
- Osteoporosis: SCORE (Simple Calculated Osteoporosis Risk Estimation) will be used to screen subjects who require DEXA. Subjects with T-score < -2.5 will be excluded
- Paget's disease, osteomalacia, or any other metabolic bone disease
- Use of medications or any drug known to potentially interfere with bone/soft tissue healing (e.g. chronic systemic steroids)
- Planned use of Bone Morphogenetic Protein (BMP)
- Unlikely to comply with the follow-up evaluation schedule
- Subject has recent history (less than 3 years) of chemical substance dependency or significant psychosocial disturbance that may impact the outcome or study participation
- Participation in a clinical trial of another investigational drug or device within the past 30 days
- Systemic infection such as AIDS, HIV, and active hepatitis
- Active malignancy defined as history of invasive malignancy, except if the subject has received treatment and displayed no clinical signs and symptoms for at least five years
- Pregnant or planning to become pregnant during the length of study participation
- Involvement in active litigation related to back problems at the time of screening
- Direct involvement in the execution of this protocol
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Kansas University Medical Center
Kansas City, Kansas, 66160
New York University School of Medicine
New York, New York, 10016
Pomona Valley Hospital Medical Center
Pomona, California, 91767
University of California, Davis
Sacramento, California, 95817
South Texas Spine
San Antonio, Texas, 78229
About this study
Official title: A Multi-Center Prospective Randomized Study to Evaluate the Efficacy of the Aspen Spinous Process System for Use in Anterior Lumbar Interbody Fusion (ALIF)
This is a multi-center, prospective randomized clinical study to evaluate the clinical outcome of subjects with degenerative disc disease (DDD) treated with ALIF and supplemental posterior fixation using ASPEN Spinous Process System compared to pedicle screw instrumentation.
Read the detailed description
This is a multi-center, prospective randomized clinical study to evaluate the clinical outcome of subjects with DDD who are treated with ALIF and supplemental posterior fixation using Aspen compared to pedicle screw instrumentation. The study will involve up to approximately 25 investigational sites and enroll up to 156 67 subjects. The randomization ratio of two Aspen subjects to one pedicle screw subject (2:1) will be utilized.
Subjects with lumbar DDD who are candidates for ALIF at a single level will be screened for inclusion in the study. If the subject meets all of the eligibility criteria, they will be enrolled and randomized to either the Aspen or pedicle screw group. Subjects will continue to be followed by the guidelines set forth in this clinical protocol, which include: a postoperative discharge exam; six week, three month, six month, and one year post-op visits; and, concludes with a two year post-op visit. The follow-up is counted from the day of surgery. The enrollment period is expected to be approximately 12 months and subjects will be followed for 2 years post-op for the duration of the clinical investigation. The anticipated duration of the study is approximated to be 3 years.
- Conditions
- Degenerative Disc Disease
- Being tested
- Aspen Spinous Process System, Pedicle Screw Fixation
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspen Spinous Process SystemDevice
Aspen Spinous Process System is an interspinous process fixation device
Pedicle Screw FixationDevice
Pedicle Screws are used for the fixation of the spine
| Study group | Role | What they receive |
|---|---|---|
| Aspen Spinous Process System | Experimental | Subjects randomized to the Aspen study arm will have the Aspen device implanted as supplemental posterior fixation only and according to the manufacturer's recommendations. Receives: Device: Aspen Spinous Process System |
| Pedicle Screw Fixation | Active comparator | Subjects randomized to the pedicle screw group will have the pedicle screws implanted according to the standard procedures and practices at that institution. The procedure may be performed according to surgeon preference, including a traditional open, minimally invasive or percutaneous approach. Only pedicle screws cleared by FDA for this indication will be used in this study. Receives: Device: Pedicle Screw Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODI)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: Protocol amended to NCT01549366 and participants rolled into study
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kee Kim, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01016314
- Sponsor's protocol ID
- ASP-09-001
- Status last verified
- Jan 2019
- First submitted
- 18 Nov 2009
- Last updated
- 23 Jan 2019
- 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 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Prospective Randomized Study to Evaluate the Efficacy of the Aspen Spinous Process System for Use in Anterior Lumbar Interbody Fusion (ALIF)
- ClinicalTrials.gov ID
- NCT01016314
- Acronym / sponsor ID
- ASP-09-001
- Conditions
- Degenerative Disc Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Protocol amended to NCT01549366 and participants rolled into study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Nov 2009 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 19 Nov 2009 (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 is a multi-center, prospective randomized clinical study to evaluate the clinical outcome of subjects with degenerative disc disease (DDD) treated with ALIF and supplemental posterior fixation using ASPEN Spinous Process System compared to pedicle screw instrumentation.
Detailed description
This is a multi-center, prospective randomized clinical study to evaluate the clinical outcome of subjects with DDD who are treated with ALIF and supplemental posterior fixation using Aspen compared to pedicle screw instrumentation. The study will involve up to approximately 25 investigational sites and enroll up to 156 67 subjects. The randomization ratio of two Aspen subjects to one pedicle screw subject (2:1) will be utilized.
Subjects with lumbar DDD who are candidates for ALIF at a single level will be screened for inclusion in the study. If the subject meets all of the eligibility criteria, they will be enrolled and randomized to either the Aspen or pedicle screw group. Subjects will continue to be followed by the guidelines set forth in this clinical protocol, which include: a postoperative discharge exam; six week, three month, six month, and one year post-op visits; and, concludes with a two year post-op visit. The follow-up is counted from the day of surgery. The enrollment period is expected to be approximately 12 months and subjects will be followed for 2 years post-op for the duration of the clinical investigation. The anticipated duration of the study is approximated to be 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspen Spinous Process System | Experimental | Device: Aspen Spinous Process SystemSubjects randomized to the Aspen study arm will have the Aspen device implanted as supplemental posterior fixation only and according to the manufacturer's recommendations. |
| Pedicle Screw Fixation | Active comparator | Device: Pedicle Screw FixationSubjects randomized to the pedicle screw group will have the pedicle screws implanted according to the standard procedures and practices at that institution. The procedure may be performed according to surgeon preference, including a traditional open, minimally invasive or percutaneous approach. Only pedicle screws cleared by FDA for this indication will be used in this study. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 75 years
- Scheduled for an elective single level ALIF with posterior fixation
- Diagnosis of primary symptomatic DDD confirmed with appropriate imaging studies and/or positive lumbar discography
- Oswestry Disability Index (ODI) v 2.1 score >30%
- Failed at least 6 weeks of conservative care (non-surgical)/clinical signs of neurological deterioration
Key exclusion criteria (21 listed)
- Prior lumbar fusion surgery at any level (prior discectomy and/or laminectomy allowed)
- Spondylolisthesis grade 3 or more
- Lytic spondylolisthesis
- Incompetent or missing posterior arch at the affected level (e.g. laminectomy, pars defect)
- Currently requires laminectomy at level of surgery
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 |
|---|---|---|
| Aspen Spinous Process SystemAspen Spinous Process System is an interspinous process fixation device | Device | Aspen Spinous Process System |
| Pedicle Screw FixationPedicle Screws are used for the fixation of the spine | Device | Pedicle Screw Fixation |
Primary outcome
Oswestry Disability Index (ODI)
Time frame: 2 years
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 23 Jan 2019.
- 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.
Kee Kim, MD principal investigator
University of California, Davis
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspen Spinous Process System and Pedicle Screw Fixation in people with Degenerative Disc Disease, run by Zimmer Biomet at 5 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 21 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 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 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.
What does the primary outcome measure?
Oswestry Disability Index (ODI) (time frame: 2 years). 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 23 Jan 2019.