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Degeneration of Lumbar Intervertebral DiscNCT01549366

Comparison of the Aspen Device Versus Pedicle Screws for Supplemental Posterior Fixation in Lumbar Interbody Fusion

A study testing Aspen Spinous Process Fixation Device and Pedicle Screws in people with Degeneration of Lumbar Intervertebral Disc, run by Zimmer Biomet at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this clinical investigation is to evaluate the Aspen™ device compared to pedicle screw instrumentation for posterior fixation in the treatment of patients with degenerative disc disease and/or spondylolisthesis. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Aspen Spinous Process Fixation Device and Pedicle Screws
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
3 sitesUnited States
Study dates
Feb 2012to 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 circumferential lumbar fusion by means of supplemental posterior fusion with fixation (allowing for the placement of ASPEN or pedicle screws) for an anterior or lateral interbody fusion
  • Diagnosis of primary symptomatic Degenerative Disc Disease (DDD) and/or spondylolisthesis confirmed with appropriate imaging studies and/or positive lumbar discography
  • Oswestry Disability Index (ODI) v2.1 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

  • Previous fusion at the operative level
  • Spondylolisthesis Grade 3 or more
  • Lytic spondylolisthesis
  • 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
Show all 24Show fewer
  • Vertebral body compromise or acute fracture at implant level
  • Body mass Index (BMI) ≥ 35
  • Known allergy to titanium
  • Osteoporosis: Simple Calculated Osteoporosis Risk Estimation (S.C.O.R.E.) > 6 AND Dual-energy X-ray absorptiometry (DEXA) T-score < -2.5
  • 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)
  • Planned use of Bone Morphogenetic Protein (BMP) for posterolateral fusion*
  • 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
  • Subject is a prisoner
  • 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
  • Pre-existing conditions that could interfere with the evaluation of outcome measures (e.g. musculoskeletal, neuromuscular, etc.)

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Buffalo Spine Surgery

    Lockport, New York, 14094

  • Andy Kranenburg

    Medford, Oregon, 97504

  • Clint Hill

    Paducah, Kentucky, 42001

Other trials in United States

About this study

Official title: A Multi-Center Prospective Randomized Study Comparing Supplemental Posterior Instrumentation, Aspen™ Spinous Process System Versus Pedicle Screw Fixation, in Lateral Lumbar Interbody Fusion (LLIF) or Anterior Lumbar Interbody Fusion (ALIF)

The purpose of this clinical investigation is to evaluate the Aspen™ device compared to pedicle screw instrumentation for posterior fixation in the treatment of patients with degenerative disc disease and/or spondylolisthesis. The Aspen™ device will be compared to pedicle screw instrumentation in Oswestry Disability Index (ODI) improvement and success of fusion.

Read the detailed description

This is a multi-center, prospective randomized clinical study to evaluate the clinical outcome of subjects with degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) and/or spondylolisthesis utilizing either Aspen Spinous Process Fixation System or Pedicle Screws for supplemental posterior instrumentation as an adjunct to an anterior or lateral approach to lumbar interbody fusion.

The primary hypothesis is that change in Oswestry Disability Index (ODI) of subjects in the study group (Aspen) will be non-inferior to the control group (pedicle screw instrumentation). The non-inferiority margin is pre-specified to be 10 ODI score points. If the non-inferiority is established, superiority of Aspen to the control will be tested.

The study will involve up to 25 investigational sites. Enrollment is expected to take approximately 24 months. Subjects will be followed for 2 years, with the anticipated duration of the study being approximately 4 years from start to finish.

Being tested
Aspen Spinous Process Fixation Device, Pedicle Screws

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 Lateral Lumbar Interbody Fusion (LLIF) or Anterior Lumbar Interbody Fusion (ALIF)

  • Pedicle ScrewsDevice

    Pedicle Screws will be placed as posterior fixation to Lateral Lumbar Interbody Fusion (LLIF) or Anterior Lumbar Interbody Fusion (ALIF)

Study groups in NCT01549366
Study groupRoleWhat they receive
Aspen Spinous Process Fixation DeviceExperimentalSubjects 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 Fixation Device
Pedicle ScrewsActive comparatorSubjects randomized to the pedicle screw group will have polyaxial top loading 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 Screws

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absolute change in Oswestry Disability Index (ODI)

    Measured: baseline to 12 months post-operative

Secondary outcomes (8)

  1. Fusion success

    Measured: 12 months and 24 months

  2. Neurological status

    Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months, & 24 months

  3. Change in EQ-5D-3L

    Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months, & 24 months

  4. Change in SF-36

    Measured: Baseline, 12 months & 24 months

  5. Change in Visual Analogue Scale (VAS) (pain)

    Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months, & 24 months

  6. Change in Zurich Claudication Questionnaire

    Measured: Baseline, 12 months & 24 months

  7. Pain medication usage

    Measured: Baseline, surgery, 6 weeks, 3 months, 6 months, 12 months, & 24 months

  8. Operative parameters (estimate blood loss, fluor time, length of hospital stay)

    Measured: Intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionJan 2016
  4. Study completionJan 2016

Resources

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
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01549366
Sponsor's protocol ID
ASP-11-001
Status last verified
Mar 2018
First submitted
29 Feb 2012
Last updated
7 Mar 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Aspen Spinous Process Fixation Device and Pedicle Screws in people with Degeneration of Lumbar Intervertebral Disc, run by Zimmer Biomet at 3 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 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: finished, as of the sponsor's last update on 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

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?

On the ClinicalTrials.gov record for NCT01549366.

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 7 Mar 2018.

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