SpondylolisthesisNCT01560273
Aspen Spinous Process Fixation System for Use in PLF in Patients With Spondylolisthesis
An observational study of Spondylolisthesis, run by Zimmer Biomet at 5 sites in United States.
Trial summary
The purpose of this clinical investigation is to evaluate the clinical outcomes of subject with spondylolisthesis undergoing posterolateral fusion (PLF) surgery utilizing the Aspen™ Spinous Process Fixation System. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Spondylolisthesis
- What is being tested?
- Aspen Spinous Process Fixation Device
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 5 sitesUnited States
- Study dates
- Feb 2012to Sep 2015
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 50 years and older with spondylolisthesis requiring a single level posterolateral decompression and posterolateral fusion
Who may be able to join
- Age between 50 and older
- Diagnosis of mild segmental instability on standing radiography lateral film defined as degenerative spondylolisthesis ≤ 4mm in dynamic imaging (i.e., flexion/extension)
- Scheduled for an elective single-level posterior decompression and posterolateral fusion using AspenTM spinous process fixation system
- Oswestry Disability Index (ODI) v 2.1 score >30%
- Failed at least 3 months of conservative care (non-surgical) OR has clinical signs of neurological deterioration
- Signed Informed Consent Form
Who cannot join
- Pre-operative
- Marked degenerative spondylolisthesis (>4mm)
- Lesions requiring surgery involving two levels
- Prior surgery at index level or adjacent level
- Prior spinal fusion surgery
- Isthmic or lytic spondylolisthesis
Show all 29Show fewer
- Incompetent or missing posterior arch at the affected level (e.g. complete laminectomy, pars defect)
- Requires complete laminectomy at level of surgery
- Facet joints at implant level are absent or fractured
- Vertebral body compromise or acute fracture at implant level
- Body mass Index (BMI) ≥ 35
- Known allergy to titanium
- Osteoporosis: SCORE (Simple Calculated Osteoporosis Risk Estimation) will be used to screen subjects requiring 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 additional segmental fixation (eg. facet screws, anterior/lateral plating, anchored cages)
- Use of Bone Morphogenetic Protein (BMP)*
- Unlikely to comply with the follow-up evaluation schedule
- In the opinion of the Investigator, Subject has history of chemical substance dependency or significant psychosocial disturbance that may impact the outcome or study participation
- Active participation in a clinical trial of another drug or device
- Active systemic infection or any other health condition that would preclude surgery
- 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 study participation
- Involvement in active litigation related to back problems at the time of screening
- Direct involvement in the execution of this protocol
- Pre-existing conditions that could interfere with the evaluation of outcome measures (e.g. musculoskeletal, neuromuscular, etc.)
- Intra-operative Exclusion
- Intra-operative visualization of a > 4mm spondylolisthesis not previously noted radiographically
- Any change in the surgical procedure that violates the inclusion/exclusion criteria. (eg. switching to double level procedure; placing pedicle screws as posterior fixation).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Goodman Campbell Brian and Spine
Indianapolis, Indiana, 47905
Buffalo Spine Surgery
Lockport, New York, 14094
Community Orthopedic Medical Group
Mission Viejo, California, 92691
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
Pacific Spine Specialists
Tualatin, Oregon, 97062
About this study
Official title: A Multi-Center Prospective Study Evaluation Aspen Spinous Process Fixation System for Use in Posterolateral Fusion (PLF) in Patients With Spondylolisthesis
The purpose of this clinical investigation is to evaluate the clinical outcomes of subject with spondylolisthesis undergoing posterolateral fusion (PLF) surgery utilizing the Aspen™ Spinous Process Fixation System. The Aspen™ device will be evaluated using Oswestry Disability Index (ODI) improvement and success of fusion.
Read the detailed description
Evaluate the clinical outcomes of subject with spondylolisthesis undergoing posterolateral fusion (PLF) surgery utilizing the Aspen™ Spinous Process Fixation System. The Aspen™ device will be evaluated using Oswestry Disability Index (ODI) improvement and success of fusion.
- Conditions
- Spondylolisthesis
- Being tested
- Aspen Spinous Process Fixation Device
- Medical subject headings
- Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspen Spinous Process Fixation DeviceDevice
The Aspen device will be placed as posterior fixation to Posterolateral Fusion (PLF)
| Study group | Role | What they receive |
|---|---|---|
| Aspen Spinous Process Fixation Device | The Aspen device provides supplemental posterior fixation for fusion Receives: Device: Aspen Spinous Process Fixation Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in Oswestry Disability Index (ODI)
Measured: baseline to 12 months post-operative
Secondary outcomes (7)
Title: Fusion success
Measured: 12 Months post-operative
Change in Visual Analogue Scale (VAS) (pain)
Measured: Baseline, 6 weeks, 2 weeks, 3 months, 6 months, 12 months, & 24 months
Neurological status
motor functions, reflexes, and sensory
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months, & 24 months
Operative parameters (estimate blood loss, surgery time, fluoroscopy time, and length of hospital stay)
Measured: Surgical Visit
Pain medication usage
Measured: Baseline, surgery, 6 weeks, 3 months, 6 months, 12 months, & 24 months
Change in EQ-5D-3L
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months, & 24 months
Change in Zurich Claudication Questionnaire
Measured: Baseline, 12 months & 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: Will answer study question through other research means.
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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shah, Principal investigator, Goodman Campbell brain and Spine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01560273
- Sponsor's protocol ID
- ASP-11-002
- Status last verified
- Jan 2019
- First submitted
- 15 Mar 2012
- Last updated
- 9 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 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Prospective Study Evaluation Aspen Spinous Process Fixation System for Use in Posterolateral Fusion (PLF) in Patients With Spondylolisthesis
- ClinicalTrials.gov ID
- NCT01560273
- Acronym / sponsor ID
- ASP-11-002
- Conditions
- Spondylolisthesis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Will answer study question through other research means.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 22 Mar 2012 (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 clinical investigation is to evaluate the clinical outcomes of subject with spondylolisthesis undergoing posterolateral fusion (PLF) surgery utilizing the Aspen™ Spinous Process Fixation System. The Aspen™ device will be evaluated using Oswestry Disability Index (ODI) improvement and success of fusion.
Detailed description
Evaluate the clinical outcomes of subject with spondylolisthesis undergoing posterolateral fusion (PLF) surgery utilizing the Aspen™ Spinous Process Fixation System. The Aspen™ device will be evaluated using Oswestry Disability Index (ODI) improvement and success of fusion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aspen Spinous Process Fixation Device | – | Device: Aspen Spinous Process Fixation DeviceThe Aspen device provides supplemental posterior fixation for fusion |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 50 years and older with spondylolisthesis requiring a single level posterolateral decompression and posterolateral fusion
Key inclusion criteria (6 listed)
- Age between 50 and older
- Diagnosis of mild segmental instability on standing radiography lateral film defined as degenerative spondylolisthesis ≤ 4mm in dynamic imaging (i.e., flexion/extension)
- Scheduled for an elective single-level posterior decompression and posterolateral fusion using AspenTM spinous process fixation system
- Oswestry Disability Index (ODI) v 2.1 score >30%
- Failed at least 3 months of conservative care (non-surgical) OR has clinical signs of neurological deterioration
Key exclusion criteria (29 listed)
- Pre-operative
- Marked degenerative spondylolisthesis (>4mm)
- Lesions requiring surgery involving two levels
- Prior surgery at index level or adjacent level
- Prior spinal fusion 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 Fixation DeviceThe Aspen device will be placed as posterior fixation to Posterolateral Fusion (PLF) | Device | Aspen Spinous Process Fixation Device |
Primary outcome
Absolute change in Oswestry Disability Index (ODI)
Time frame: baseline to 12 months post-operative
7 secondary outcomes
Title: Fusion success
Time frame: 12 Months post-operative
Change in Visual Analogue Scale (VAS) (pain)
Time frame: Baseline, 6 weeks, 2 weeks, 3 months, 6 months, 12 months, & 24 months
Neurological status
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, & 24 months
Operative parameters (estimate blood loss, surgery time, fluoroscopy time, and length of hospital stay)
Time frame: Surgical Visit
Pain medication usage
Time frame: Baseline, surgery, 6 weeks, 3 months, 6 months, 12 months, & 24 months
Change in EQ-5D-3L
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, & 24 months
Change in Zurich Claudication Questionnaire
Time frame: Baseline, 12 months & 24 months
Results and safety
The study was stopped early (reason given: Will answer study question through other research means.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 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.
Shah principal investigator
Goodman Campbell brain and Spine
5 sites 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 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 29 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 9 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 stopped early (reason given: Will answer study question through other research means.). 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?
Absolute change in Oswestry Disability Index (ODI) (time frame: baseline to 12 months post-operative). 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 9 Jan 2019.