A Study of the Effectiveness and Safety of Oxiplex® Gel to Reduce Pain and Symptoms Following Lumbar Disc Surgery

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"Please consider joining this clinical research study if you are having surgery for a herniated lumbar disc."
Age: 22 to 70 years old
Gender:
Any
Healthy Volunteers: No
Keywords: lumbar spine surgery
Type: Device study
Target:
20 Participants
Investigator:
Description
This study will examine the safety and effectiveness of an experimental device called Oxiplex. Oxiplex gel is not yet approved in the U.S. by the FDA. Oxiplex may help prevent some of the side effects that can occur after lower back spine surgery. This includes leg pain not resolved with surgery, back pain, and neurological symptoms such as weakness and numbness.

Oxiplex gel is a sterile, bioresorbable (dissolves and absorbs into the body) product. The gel does not require removal after surgery and clears from the body.

Oxiplex may improve post-surgical leg and back pain by providing a physical barrier for the nerves around your surgical site. It is applied during the lumbar spine surgery to coat the sensory nerves. This barrier isolates the nerves from tissues and fluid that may cause inflammation in that area.
This study requires

We expect that you will be in this research study for approximately 6 months after your surgery. The study involves:

  • Physical examinations

  • Patient questionnaires

Who can participate
  • People who are having surgery for a single lower back herniated disc (L4-5 or L5-S1)

  • Have associated leg/buttocks pain

Who cannot participate:

  • If you have undergone prior lumbar surgery

  • If you are receiving worker's compensation

Please contact the study coordinator for additional participation requirements.

Benefits and risks of participating
We cannot promise any benefits to you or others from your taking part in this research. However, possible benefits include reduced pain following your surgery and or an improved post-operative outcome (for example, you may be better able to do your activities of daily living).

Please talk to your doctor about the potential risks of participation.
Compensation
If you agree to take part in this research study, you will be compensated for your time and effort with a $25.00 gift card for your completed Week 6 study visit (follow-up visit #1). At the completion of your 3 month study visit (follow-up visit #2) you will receive a $50.00 gift card. At the completion of the 6 month study visit (follow-up visit #3), you will receive a $300.00 gift card. The total potential compensation for completing all 3 follow-up visits is $375.00. If you miss a visit or do not finish the study, or if the study ends early, you will be paid only for the visits you have completed.
Resources
Schedule
Study duration and period
We expect that you will be in this research study for approximately 6 months after your surgery.
Recruitment period
From June 18, 2018
Location
UC Davis Spine Center
3301 C Street
Suite 1500
Sacramento, CA 95816
Research Topic
Conditions:
  • Herniated Lumbar Disk