This is a pivotal Randomized Clinical trial to compare the safety and effectiveness of the Pedicle Lengthening Osteotomy Procedure with implantation of the Altum® Device to open surgical decompression and Transforaminal Lumbar Interbody Fusion (TLIF) in patients with symptomatic, one or two level lumbar spinal stenosis (LSS) and one level grade I degenerative spondylolisthesis requiring surgical treatment.
LSS is a narrowing of the spinal canal and/or the intervertebral foramina by bony spurs or soft tissues that decrease space for the neural elements resulting in compression of the nerve roots or spinal cord in the lumbar region of the spine. LSS can cause low back pain, weakness, numbness, and pain and loss of sensation in the buttocks and legs. In most cases the symptoms improve when the patient is sitting or leaning forward, due to the flexed position of the vertebra which leads to reduced impingement of the neural tissue. In addition, many patients with LSS complain of pain when standing and walking referred to as neurogenic intermittent claudication (NIC). Nonsurgical management is well-established as the first-line treatment approach for LSS patients with mild to moderate symptoms. It typically involves the prescription of modified physical activity, physiotherapy, anti-inflammatory drugs, epidural steroid injections, use of a lumbar corset or some combination thereof. Surgical treatment is reserved for patients who do not obtain adequate relief of symptoms by conservative management. The goal of surgical treatment for LSS is to relieve the compression of the spinal nerves in the spinal canal or neural foramina. Such decompressive surgery generally involves laminectomy, laminotomy, foraminotomy, partial facetectomy or some combination thereof. Decompressive surgery in subjects with LSS and spondylolisthesis commonly requires fusion to stabilize the spondylolisthesis. The most commonly performed lumbar fusion for patient's with the combination of LSS and spondylolisthesis is a Transforaminal Lumbar Interbody Fusion (TLIF) which involves stabilizing the motion segment by placing pedicle screws, rods and an interbody fusion cage. Autograft or allograft bone are commonly used to bring about fusion or a bridging of bone across the intervertebral joint. The Altum® Pedicle Osteotomy System contains the implants and instruments required to perform the pedicle lengthening osteotomy procedure for the treatment of LSS. The Altum® implant is an expandable bone screw that is available in a variety of sizes (7.5 mm, 8.5 mm and 9.5 mm). Altum® instruments are manufactured from IXEF PARA GS-1022 GY/51, medical grade titanium alloy (Ti 6AL-4V ELI ASTM F-136), and medical grade stainless steel (17-4 ASTM F899).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
344
Decompressive surgery via Pedicle lengthening osteotomy using Altum Device. Altum is intended for pedicle lengthening to correct degenerative lumbar spinal stenosis in the presence of a grade 1 degenerative spondylolisthesis. The Altum bone saw is designed for creating an osteotomy at the base of each pedicle. The Altum implant is designed for distraction of the pedicle osteotomy and for lengthening of the pedicles. Altum is appropriate for skeletally mature adults with symptomatic stenosis at one or two levels between L2-L5.
Decompressive surgery via open surgical decompression and Transforaminal Lumbar Interbody Fusion (TLIF) using either a midline or paramedian incision with implantation of bilateral pedicle screws (4 screws) and rods (2 rods) and an interbody fusion cage (1 PEEK fusion cage, coated or uncoated): 1. DePuy Synthes Expedium® 5.5 System, Stryker Xia 5.5 System, Medtronic CD Horizon Solera 5.5 Systemor Innovative Surgical Designs True Spinal Fixation System; and 2. DePuy Synthes Concord TLIF cage, Stryker UniLIF TLIF cage, Medtronic Capstone TLIF cage or Meditech Talos TLIF cage.
Rothman Institute
Bryn Mawr, Pennsylvania, United States
Zurich Claudication Questionnaire (ZCQ)
Clinically significant improvement in outcomes ZCQ scores compared to baseline * Improvement in physical function by \> 0.5 points * Improvement in symptom severity by \> 0.5 points * "Satisfied" or "somewhat satisfied" as defined by a score of \< 2.5 points on the patient satisfaction domain
Time frame: 24 months
No reoperations
No re-operations, removals, revisions or supplemental fixation at the index level.
Time frame: Index level
Adjacent level surgery
No additional surgery at the adjacent levels
Time frame: 24 months
Adverse events
No major device-related adverse events
Time frame: 24 months
Radiological Success
Presence of continuous bridging bone across both pedicle osteotomy sites on CT scanning, * No evidence of bridging bone between the upper and lower vertebral endplates on CT scanning, and evidence of continued motion as demonstrated on flexion-extension films * Absence of a major device related adverse event (device breakage, disassembly or migration)
Time frame: 24 months
Oswestry Disability Index
Improvement in Oswestry Disability Index v2.1a \> 15 points from baseline to 24 months
Time frame: 24 months
EQ5D
Change in EQ5D from baseline to 24 months
Time frame: 24 months
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SF-12
Change in SF-12v2.0™ from baseline to 24 months
Time frame: 24 months
Pain Visual Analog Scale (VAS) for Back and Leg
Pain Visual Analog Scale (VAS) is a measure of pain intensity. It is a continuous scale comprised of a 100mm line ranging from 0 (no pain) to 10 (worst imaginable pain). Patients mark a line on the scale depicting their pain level. A VAS score is determined by measuring where the mark is made relative to the ends of the line. VAS will be done separately for low back, right leg and left leg pain.Improvement in VAS for back, right leg and left leg pain of 20/100mm from baseline to 24 months
Time frame: 24 months
Cost
Direct costs of the episode of care
Time frame: Index surgery
Opioid use
Use of opioid analgesics
Time frame: baseline to 24 months
Return to work
Patient will report the date of which they return to work
Time frame: Anytime from discharge after surgery up to 24 months (+/- 60 days)
Daily activities
Time for return to usual daily activities
Time frame: baseline to 24 months
Patient Satisfaction
A series of questions intended to assess the effects of the procedure itself on your well-being, and does not refer to the hospital or its staff. One out of 5 statements will be chosen based on the patient's level of satisfaction: The procedure results met my expectations and I feel better than I did before surgery; The procedure improved my condition enough that I would go through it again for the same outcome; The procedure helped me but I would not go through it again for the same outcome; I feel the same or worse compared to before surgery. Furthermore, patients will be ask to choose one statement based on how they feel today compared to their last visit: I feel much better; I feel somewhat better; I feel somewhat worse; I feel much worse.
Time frame: 24 months