Clinical trial NCT01560273: Aspen Spinous Process Fixation System for Use in PLF in Patients With Spondylolisthesis
Official title: A Multi-Center Prospective Study Evaluation Aspen Spinous Process Fixation System for Use in Posterolateral Fusion (PLF) in Patients With Spondylolisthesis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Spondylolisthesis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2012-03-22
Enrollment: 25
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 50 years and older with spondylolisthesis requiring a single level posterolateral decompression and posterolateral fusion

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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
* 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).

Primary outcomes:
measure: Absolute change in Oswestry Disability Index (ODI)
timeFrame: baseline to 12 months post-operative
Secondary outcomes:
measure: Title: Fusion success
timeFrame: 12 Months post-operative
measure: Change in Visual Analogue Scale (VAS) (pain)
timeFrame: Baseline, 6 weeks, 2 weeks, 3 months, 6 months, 12 months, & 24 months
measure: Neurological status
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 12 months, & 24 months
measure: Operative parameters (estimate blood loss, surgery time, fluoroscopy time, and length of hospital stay)
timeFrame: Surgical Visit
measure: Pain medication usage
timeFrame: Baseline, surgery, 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 Zurich Claudication Questionnaire
timeFrame: Baseline, 12 months & 24 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
city: Mission Viejo
country: United States
facility: Community Orthopedic Medical Group
state: California
city: Indianapolis
country: United States
facility: Goodman Campbell Brian and Spine
state: Indiana
city: Lockport
country: United States
facility: Buffalo Spine Surgery
state: New York
city: Tualatin
country: United States
facility: Pacific Spine Specialists
state: Oregon
Study officials:
affiliation: Goodman Campbell brain and Spine
name: Shah
role: PRINCIPAL_INVESTIGATOR
References: