coflex® Interlaminar Stabilization for Spinal Stenosis
(PAS003 Trial)
Recruiting in Palo Alto (17 mi)
+14 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Surgalign Spine Technologies
Disqualifiers: Osteoporosis, Morbid obesity, Infection, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial evaluates the safety and effectiveness of the coflex® device for patients with spinal stenosis and low back pain. The device is a small implant that helps stabilize the spine and relieve nerve pressure. The study aims to see how well it works over an extended period. The Coflex device has been studied extensively for its effectiveness in treating lumbar spinal stenosis and degenerative lumbar diseases, with multiple studies showing its long-term efficacy and safety.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the Coflex Interlaminar Stabilization treatment for spinal stenosis?
Research shows that the Coflex Interlaminar Stabilization treatment is effective for improving symptoms in patients with lumbar spinal stenosis, as it provides stability and helps relieve pressure on the spine. Studies have demonstrated significant improvements in pain and disability scores, and the treatment has been shown to be a cost-effective alternative to traditional spinal fusion surgery.
12345Is the coflex® Interlaminar Stabilization device safe for humans?
The coflex® Interlaminar Stabilization device has been studied in clinical trials and shown to be safe for use in humans, with successful implantation and significant improvement in patients with lumbar spinal stenosis over a follow-up period of at least four years.
12346How does the Coflex Interlaminar Stabilization treatment differ from other treatments for spinal stenosis?
The Coflex Interlaminar Stabilization treatment is unique because it is a minimally invasive implant that provides dynamic stabilization of the spine after decompression surgery, offering an alternative to more invasive spinal fusion procedures. It is designed to maintain motion in the spine, potentially leading to quicker recovery and less long-term stiffness compared to traditional fusion methods.
12457Eligibility Criteria
This trial is for adults with leg, buttock, or groin pain from spinal stenosis that eases when sitting. They must have significant back pain and disability, confirmed lumbar stenosis needing surgery, tried injections or 6 months of other treatments without relief, and be able to follow the study plan. Excluded are those with prior major spine surgeries, certain bone conditions, severe scoliosis or osteoporosis risks, titanium allergies, infections, specific neurological disorders like cauda equina syndrome.Inclusion Criteria
I am mentally and physically capable of following the study's requirements.
I experience leg or groin pain that eases when I sit or bend forward.
I've had a lumbar injection or 6 months of care without relief.
+9 more
Exclusion Criteria
I have had spine surgery at the specific lower back level.
I have had spine damage due to injury or cancer.
I need a lot of bone removed due to severe spine joint enlargement, which could cause instability.
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo decompression surgery with additional stabilization using the coflex® Interlaminar Technology
6 weeks
1 visit (in-person) for surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment, with evaluations at multiple time points
60 months
Regular visits at 6 weeks, 12, 24, 36, 48, and 60 months
Long-term Evaluation
Extended evaluation of clinical outcomes and device performance over 5 years
60 months
Participant Groups
The study evaluates a device called coflex® Interlaminar Technology used after decompression surgery in patients with degenerative spinal stenosis and low back pain. It's a long-term assessment over 2 and 5 years to see how well this technology works under actual use conditions as approved by the FDA.
2Treatment groups
Experimental Treatment
Active Control
Group I: The coflex® Interlaminar TechnologyExperimental Treatment1 Intervention
The coflex device was designed to address the clinical needs of spinal stenosis patients by providing stabilization of the affected level without fusion. The coflex is an interspinous process functional dynamic implant designed to impart a stabilizing effect at the treated level(s). The coflex device was approved by FDA in 2012.
Group II: DecompressionActive Control1 Intervention
Lumbar decompression back surgery is when a small portion of the bone over the nerve root and/or disc material from under the nerve root is removed to give the nerve root more space and provide a better healing environment.
coflex® Interlaminar Technology is already approved in United States for the following indications:
🇺🇸 Approved in United States as Coflex Interlaminar Technology for:
- Moderate to severe lumbar spinal stenosis with or without back pain
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
23_University Orthopaedic Associates at Great NeckGreat Neck, NY
Northwell Health Physician Partners Orthopaedic Institute at Great NeckGreat Neck, NY
25_Orthopedic Specialist of Northwest IndianaMunster, IN
Desert Institute for Spinal Care (DISC)Phoenix, AZ
More Trial Locations
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Who Is Running the Clinical Trial?
Surgalign Spine TechnologiesLead Sponsor
Xtant MedicalLead Sponsor
MCRA, LLCIndustry Sponsor
MCRAIndustry Sponsor
References
Comparative cost effectiveness of Coflex® interlaminar stabilization versus instrumented posterolateral lumbar fusion for the treatment of lumbar spinal stenosis and spondylolisthesis. [2023]Symptomatic chronic low back and leg pain resulting from lumbar spinal stenosis is expensive to treat and manage. A randomized, controlled, multicenter US Food and Drug Administration Investigational Device Exemption clinical trial assessed treatment-related patient outcomes comparing the Coflex® Interlaminar Stabilization Device, an interlaminar stabilization implant inserted following decompressive surgical laminotomy in the lumbar spine, to instrumented posterolateral fusion among patients with moderate to severe spinal stenosis. This study uses patient-reported outcomes and clinical events from the trial along with costs and expected resource utilization to determine cost effectiveness.
Therapeutic sustainability and durability of coflex interlaminar stabilization after decompression for lumbar spinal stenosis: a four year assessment. [2020]Approved treatment modalities for the surgical management of lumbar spinal stenosis encompass a variety of direct and indirect methods of decompression, though all have varying degrees of limitations and morbidity which potentially limit the efficacy and durability of the treatment. The coflex(®) interlaminar stabilization implant (Paradigm Spine, New York, NY), examined under a United States Food and Drug Administration (US FDA) Investigational Device Exemption (IDE) clinical trial, is shown to have durable outcomes when compared to posterolateral fusion in the setting of post-decompression stabilization for stenotic patients. Other clinical and radiographic parameters, more indicative of durability, were also evaluated. The data collected from these parameters were used to expand the FDA composite clinical success (CCS) endpoint; thus, creating a more stringent Therapeutic Sustainability Endpoint (TSE). The TSE allows more precise calculation of the durability of interlaminar stabilization (ILS) when compared to the fusion control group.
Does an interspinous device (Coflex) improve the outcome of decompressive surgery in lumbar spinal stenosis? One-year follow up of a prospective case control study of 60 patients. [2022]A number of interspinous process devices have recently been introduced to the lumbar spinal market as an alternative to conventional surgical procedures in the treatment of symptomatic lumbar stenosis. One of those "dynamic" devices is the Coflex device which has been already implanted worldwide more than 14,000 times. The aim of implanting this interspinous device is to unload the facet joints, restore foraminal height and provide stability in order to improve the clinical outcome of surgery. Published information is limited, and there are so far no data of comparison between the implant and traditional surgical approaches such as laminotomy. The purpose of our prospective study is to evaluate the surgical outcome of decompressive surgery in comparison to decompressive surgery and additional implantation of the Coflex interspinous Device. 60 patients who were all treated in the Spine Center of Klinikum Neustadt, Germany for a one or two level symptomatic LSS with decompressive surgery were included. Two groups were built. In Group one (UD) we treated 30 patients with decompression surgery alone and group two (CO) in 30 patients a Coflex device was additional implanted. Pre- and postoperatively disability and pain scores were measured using the Oswestry disability index (ODI), the Roland-Morris score (RMS), the visual analogue scale (VAS) and the pain-free walking distance (WD). Patients underwent postoperative assessments 3, 6 and 12 month including the above-mentioned scores as well as patient satisfaction. In both groups we could see a significant improve (p
Application of the Coflex Interlaminar Stabilization in Patients With L5/S1 Degenerative Diseases: Minimum 4-Year Follow-up. [2017]The Coflex is one of the representatives of posterior dynamic interspinous process device, but no study with the application of Coflex interlaminar stabilization in L5/S1 level has been performed. The aim of this study was to evaluate the feasibility and validity of the Coflex interlaminar stabilization in the treatment of degenerative lumbar diseases on L5/S1 level. A retrospective study was conducted for a consecutive series of 33 patients with degenerative lumbar spinal stenosis or lumbar disc herniation located in L5/S1 between November 2007 and September 2010. Subjects were all received decompressive laminectomy with implantation of Coflex device. Clinical effects were evaluated by visual analog scale and Oswestry Disability Index. Radiographs were done preoperatively, postoperatively, and at final follow-up. The Coflex devices were successfully implanted in all subjects. Fourteen cases completed the operations by inverting the prosthesis on account of too short S1 spinous processes. During the minimum 4-year follow-up period, all patients had obvious improvement in clinical effects (P 0.05). The Coflex is an efficacious dynamic interspinous process device for the treatment of degenerative lumbar diseases that can apply to L5/S1.
Early Functional Outcomes in Low Back Pain Subjects with a Novel Interspinous Fusion Device: REFINE Study 6-Month Results. [2023]Lumbar interlaminar decompression with interspinous fixation is an established safe and effective treatment for spinal stenosis. Early maintenance of improvements in pain intensity and function are critical for durability of symptom relief. The purpose of this study was to investigate the efficacy of minimally invasive treatments for low back pain during the early period after treatment and their utility in setting the course for longer term success.
Efficacy and Safety of Lumbar Dynamic Stabilization Device Coflex for Lumbar Spinal Stenosis: A Systematic Review and Meta-analysis. [2023]This systematic review and meta-analysis were performed to investigate evidence for the comparison of lumbar dynamic stabilization device Coflex (Surgalign, Deerfield, IL) with posterior lumbar fusion for lumbar spinal stenosis).
Real world adverse events of interspinous spacers using Manufacturer and User Facility Device Experience data. [2021]Lumbar spinal stenosis is a condition of progressive neurogenic claudication that can be managed with lumbar decompression surgery or less invasive interspinous process devices after failed conservative therapy. Popular interspinous process spacers include X-Stop, Vertiflex and Coflex, with X-Stop being taken off market due to its adverse events profile.