An interventional study of Pedicle Lengthening Osteotomy with Altum® Device and Control in Lumbar Spinal Stenosis, Spondylolisthesis, Grade 1 and Neurogenic Claudication, sponsored by Innovative Surgical Designs. Suspended at 1 site in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-08-03.
Sponsored by Innovative Surgical Designs · Not applicable, Interventional, and Treatment
Among 151 studies in Spinal Stenosis with a site in United States — 27 open to participants now, 32 under way, 2 of them phase 3. Spinal Stenosis · United States.
Among the 151 studies in Spinal Stenosis with a site in United States, this one is the 9th largest by planned enrollment of the 110 interventional ones that give a count, is one of 14 that started in 2017, is one of 68 with no phase, and was the 87th registered.
458 studies on the registry are indexed under Spinal Stenosis; 105 are open to participants now.
Browse Spinal Stenosis studies →27 of the 151 studies in Spinal Stenosis with a site in United States are open now. Recruiting first, the newest first:
Brigham and Women's Hospital · Sites in United States
EicOsis Human Health Inc. · Sites in United States
VA Office of Research and Development · Sites in United States
Spinal Simplicity LLC · Sites in United States
Dartmouth-Hitchcock Medical Center · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 66 Spinal Stenosis studies recruiting now, 30 (45%) set no upper age limit and 9 (14%) stop at 75 or younger; 2 take children under 18; 6 take healthy volunteers.
This study: 40 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
151 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 10 · Phase 3 10 · Phase 4 19
First in 2000; this study’s year is marked. 14 started in 2017.
This study's planned enrollment of 344 is above the median of 80 across 281 interventional studies indexed under Spinal Stenosis.
Median enrollment 60 across the 110 interventional studies, 200 across the 41 observational. Of the 96 that completed or were terminated, 41 (43%) have results posted.
This tab as a report to print or save as PDF → With an account.
59 of 151 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Innovative Surgical Designs as lead sponsor.
Innovative Surgical Designs has 1 study filed under Spinal Stenosis — fewer than ten, so there is no comparison to draw.
10 of the studies in Spinal Stenosis with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06140927Phase 3University of California, San FranciscoEffect of Ketamine on Intraoperative Motor Evoked Potentials | 2026-12-01 |
| NCT05058287Phase 3Hospital for Special Surgery, New YorkLumbar Steroid Use in Patients Undergoing Posterior Lumbar Decompression | 2026-12-31 |
| NCT06157177Primus PharmaceuticalsEfficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions. | 2026-11-15 |
| NCT03072927Stryker InstrumentsMILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study | 2026-12 |
| NCT04992572Stanford UniversityStudy Comparing Local/ MAC Anesthesia in Lumbar Decompression | 2026-12-31 |
Among the 151 studies in Spinal Stenosis with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lumbar decompressive surgery via Pedicle Lengthening Osteotomy Procedure with the Altum® Device
Device: Pedicle Lengthening Osteotomy with Altum® Device
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.
Device: Control
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.
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
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
Started Oct 2017 (actual). Primary completion is estimated for Oct 2022, 60 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is suspended, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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