Clinical trial NCT01549366: Comparison of the Aspen Device Versus Pedicle Screws for Supplemental Posterior Fixation in Lumbar Interbody Fusion
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degeneration of Lumbar Intervertebral Disc
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2012-03-09
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. The Aspen™ device will be compared to pedicle screw instrumentation in Oswestry Disability Index (ODI) improvement and success of fusion.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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.)

Primary outcomes:
measure: Absolute change in Oswestry Disability Index (ODI)
timeFrame: baseline to 12 months post-operative
Secondary outcomes:
measure: Fusion success
timeFrame: 12 months and 24 months
measure: Neurological status
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 12 months, & 24 months
measure: Change in EQ-5D-3L
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 12 months, & 24 months
measure: Change in SF-36
timeFrame: Baseline, 12 months & 24 months
measure: Change in Visual Analogue Scale (VAS) (pain)
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 12 months, & 24 months
measure: Change in Zurich Claudication Questionnaire
timeFrame: Baseline, 12 months & 24 months
measure: Pain medication usage
timeFrame: Baseline, surgery, 6 weeks, 3 months, 6 months, 12 months, & 24 months
measure: Operative parameters (estimate blood loss, fluor time, length of hospital stay)
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Paducah
country: United States
facility: Clint Hill
state: Kentucky
city: Lockport
country: United States
facility: Buffalo Spine Surgery
state: New York
city: Medford
country: United States
facility: Andy Kranenburg
state: Oregon
Study officials:
affiliation: University of Colorado, Denver
name: Patel
role: PRINCIPAL_INVESTIGATOR
affiliation: Buffalo Spine Surgery
name: Cappuccino
role: PRINCIPAL_INVESTIGATOR
References: