Aspen Spinous Process Fixation System for Use in PLF in Patients With Spondylolisthesis
Terminated
- Conditions
- Spondylolisthesis
- Interventions
- Device: Aspen Spinous Process Fixation Device
- Registration Number
- NCT01560273
- Lead Sponsor
- Zimmer Biomet
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 25
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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Aspen Spinous Process Fixation Device Aspen Spinous Process Fixation Device The Aspen device provides supplemental posterior fixation for fusion
- Primary Outcome Measures
Name Time Method Absolute change in Oswestry Disability Index (ODI) baseline to 12 months post-operative
- Secondary Outcome Measures
Name Time Method Pain medication usage Baseline, surgery, 6 weeks, 3 months, 6 months, 12 months, & 24 months Change in Zurich Claudication Questionnaire Baseline, 12 months & 24 months Operative parameters (estimate blood loss, surgery time, fluoroscopy time, and length of hospital stay) Surgical Visit Change in EQ-5D-3L Baseline, 6 weeks, 3 months, 6 months, 12 months, & 24 months Title: Fusion success 12 Months post-operative Neurological status Baseline, 6 weeks, 3 months, 6 months, 12 months, & 24 months motor functions, reflexes, and sensory
Change in Visual Analogue Scale (VAS) (pain) Baseline, 6 weeks, 2 weeks, 3 months, 6 months, 12 months, & 24 months
Trial Locations
- Locations (5)
Community Orthopedic Medical Group
🇺🇸Mission Viejo, California, United States
St. Joseph's Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States
Buffalo Spine Surgery
🇺🇸Lockport, New York, United States
Goodman Campbell Brian and Spine
🇺🇸Indianapolis, Indiana, United States
Pacific Spine Specialists
🇺🇸Tualatin, Oregon, United States