Clinical Trial of Experimental LimiFlex for Treating Degenerative Spondylolisthesis With Spinal Stenosis (narrowing of the spine)

Enter your info and the study team will contact you soon!
Your data is securely stored and only shared with the research team
Logo Image
"UC Davis is participating in the Control Arm for this study. Website: https://limiflextrial.com/"
Age: 25 to 80 years old
Gender:
Any
Healthy Volunteers: No
Keywords: Lumbar Degenerative Spondylolisthesis with Spinal Stenosis, Lumbar Degenerative Spondylolisthesis, spinal stenosis, leg pain, back pain
Type: Device study
Target:
30 Participants
Investigator:
Description
Degenerative spondylolisthesis is when one of the bones in your spine has moved forward in relation to the vertebra below it. Degenerative spondylolisthesis can cause or worsen lumbar spinal stenosis. This is a narrowing of one or more areas in the lower part of your spine. This narrowing can put pressure on the spinal cord or spinal nerves and cause pain, numbness or weakness in your legs, back, or buttocks. To treat your condition, your doctor is recommending spinal surgery.

Before patients are enrolled into this study, doctor offices will be considered a Control Site or an Investigative Site. All patients will be offered posterior decompression surgery to help relieve abnormal pressure on nerves that are causing the pain and discomfort. This standard of care surgery is also called laminectomy. During the decompression surgery, your doctor will remove the bone in your spine that is causing your pain. The purpose of the decompression surgery is to help relieve abnormal pressure on your nerves that is causing pain and discomfort.

Dr. Kim and University of California Davis Health will be considered a Control Site. After the decompression, patients at the Control Sites will have a procedure called spinal fusion. This surgery is also called a transforaminal lumbar interbody fusion (TLIF) with posterolateral fusion (PLF) or a posterior decompression surgery with spinal fusion. In the spinal fusion procedure, bone is placed around the vertebrae to cause the vertebra to connect so that they behave and move as one block. This is called a posterior (done from the back) lumbar fusion and is done to help stabilize the spine.
This study requires

Screening visit

6 week follow-up visit,

3 month follow-up visit,

6 month follow-up visit,

1 year follow-up visit,

2 year follow-up visit.

Who can participate

Inclusion criteria (abbr.):

  1. Participants between the ages of 25 - 80
  2. Diagnosis of Grade I spondylolisthesis with Lumbar spinal stenosis
  3. Experiencing symptoms including leg pain, muscle weakness, and/or sensation abnormality, with or without back pain
  4. Persistent symptoms despite at least 3 months of conservative treatment (may include but is not limited to physical therapy, medications, and/or epidural injections)
  5. Candidate for surgical decompression and stabilization at only one level between L1-S1
  6. Participants who are willing and able to participate in the study for the duration of the study follow-up and are able to comply with study requirements

Exclusion criteria (abbr.):

  1. History of any previous surgery* at any level in the lumbosacral spine except for a discectomy or decompression
  2. History of any previous surgery* at the level planned for treatment (previous surgery includes spinal stimulator placement but does NOT include epidural injections)
  3. Isthmic spondylolisthesis or spondylolysis (pars fracture) at any level in the lumbar spine
  4. Degenerative lumbar scoliosis with a Cobb angle >10° at the affected motion segment
  5. Symptomatic lumbar stenosis that is not amenable to a direct decompression
  6. Severe osteoporosis
  7. Planned hip or knee replacement surgery
  8. Receiving immunosuppressive or long-term steroid therapy
  9. Women who are pregnant or are interested in becoming pregnant within the study period
  10. Currently seeking or receiving worker's compensation for back pain or spinal condition
  11. Current involvement in a study of another investigational product for similar purpose
  12. Current history (within 12 months) of substance abuse, including alcohol abuse
  13. A prisoner
Benefits and risks of participating
BENEFITS:

There are no benefits to you from your taking part in this research. We cannot promise any benefits to others from your taking part in this research. There are possible benefits of the standard of care surgical procedure. These include decrease in the pain, numbness or weakness in your legs, back or buttocks.

RISKS:

The study doctor will answer any questions you might have about the potential risks associated with this research study.
Compensation
You will receive compensation for your time and effort per the below schedule once each visit is completed.

$75 for each of the following study visits:
screening (if in addition to standard of care visit)
6 week
3 month

$150 for each of the following study visits:
6 month
12 month

$250 for the 2 year visit
Resources
Schedule
Study duration and period
We expect that you will be in this research study for approximately 2 years after your surgery.
Recruitment period
From Nov. 1, 2017
Location
UC Davis Spine Center
3301 C Street
Suite 1500
Sacramento, CA 95816
Contact
Revati Vishwasrao
Research Topic
Conditions:
  • Degenerative Spondylolisthesis
  • Lumbar Spinal Stenosis

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


Sending

Send SMS with Study Info:

SMS Sent!

Share Study Info via Email:


E-mail Preview