Inter Spinal Fixation and Stabilization Device for Lumbar Radiculopathy and Back Pain

Area of Science:

• Spinal Surgery
• Orthopedic Devices
• Pain Management

Background:

• Interspinal distractor fixation devices are indicated for severe low back pain, neurogenic claudication, and radiculopathy due to spinal stenosis.
• This study evaluates the efficacy of such a device in patients with severe low back pain and lumbar radiculopathy.

Purpose of the Study:

• To assess the outcomes of interspinal distractor fixation for severe low back pain and lumbar radiculopathy.
• To evaluate the safety and effectiveness of this spinal fixation system.

Main Methods:

• A retrospective study involving 13 patients treated with interspinal distractor fixation.
• Data collected via phone calls included pain scores at various timelines, with final follow-up ranging from 14 to 24 months.
• Verbal consent was obtained from all patients prior to data inclusion.

Main Results:

• 13 patients with disc protrusion and/or spinal stenosis were treated.
• No complications or reoperations were reported.
• Significant improvement was observed in the Numeric Pain Rating Scale for both back pain (p=0.000552) and radicular leg pain (p=0.000291).

Conclusions:

• The interspinal distractor fixation system is a safe and effective device for spinal decompression and stabilization.
• The procedure demonstrated statistically significant pain improvement in patients with severe low back pain and radiculopathy.
• Despite a small sample size, the results indicate excellent outcomes with this fixation system.