Clinical Evidence

LimiFlex™ Post Market Clinical Trial Shows Improvements in Function and Pain

In clinical trials, implantation with LimiFlex™ resulted in sustained improvements in function and pain. At 6, 12, and 24 months after implantation, patients reported an improved level of daily functioning and reduced leg and back pain.1 These results were seen both in patients with lumbar spinal stenosis and in patients with degenerative spondylolisthesis.

tension-band-clinical-1LimiFlex Improvement in Pain Legend

Improvement in leg pain with LimiFlex

Improvement in leg pain with LimiFlex™

Improvement in back pain with LimiFlex

Improvement in back pain with LimiFlex™

Improvement in disability with LimiFlex

Improvement in disability with LimiFlex™
ODI: Oswestry Disability Index; VAS: visual analog scale.

Improvements in functioning and pain were sustained over 2 years in patients with lumbar spinal stenosis or degenerative spondylolisthesis following implantation with LimiFlex™.

LimiFlex™ Provides Segmental Stability while Preserving Spinal Function

At 12 and 24 months after LimiFlex™ implantation in patients with degenerative spondylolisthesis, change in slip and translation (versus pre-operative baseline) was markedly less than with decompression only.1,2

Quantitative radiographic analysis of slip and translation

Quantitative radiographic analysis of slip and translation at 12 and 24 months after LimiFlex™ implantation in patients with degenerative spondylolisthesis, compared with decompression only.1,2

Radiological Outcomes for Patients with Grade I–II Single-Level Degenerative Spondylolisthesis and Spinal Stenosis5

Quantitative radiographic analysis showed excellent outcome and segmental stability while preserving mobility 24 months after decompression and LimiFlex™ implantation in patients with Grade I–II single-level lumbar degenerative spondylolisthesis.5

Changes in quantitative radiographic measurements over 24 months after decompression and LimiFlex™ implantation in patients with Grade I–II single-level degenerative spondylolisthesis.5

Changes in quantitative radiographic measurements over 24 months after decompression and LimiFlex™ implantation in patients with Grade I–II single-level degenerative spondylolisthesis.5

Dorsal Decompression With and Without LimiFlex™ Stabilization: Prospective Evaluation of 12 Months Results6

A total of sixty patients presenting with leg pain and activity-related back pain due to spinal stenosis and degenerative disc disease. A first group of thirty patients was treated with dorsal decompression and implantation of LimiFlex™. A second group of thirty patients was treated with stand-alone decompression without implantation of any device.

Interlaminar decompression with stabilization using the LimiFlex™ Paraspinous Tension Band led to a significant improvement in pain and function. Interlaminar decompression without any implant first led to significant clinical improvement in pain and function after three months but over twelve months pain and functon started to become worse.

Dorsal Decompression with and without LimiFlex Stabilization: Prospective Evaluation of 12 Month Results

Dorsal Decompression with and without LimiFlex Stabilization: Prospective Evaluation of 12 Month Results

Safety Information

There are risks associated with all surgical procedures. For complete information regarding indications for use, contraindications, warnings, precautions, adverse events, and methods of use, please refer to the instructions for use.

References

1. Simpirica Spine Post Market Clinical Study; data on file
2. Herkowitz HN and Kurz LT. J Bone Joint Surg 1991;73:802–8
3. Fielding LC, Alamin TF, Patwardhan AG et al. Eur Spine J. 2013 Aug 17 DOI 10.1007/s00586-013-2934-y
4. Fry R et al. Spine J 2009;9:139S
5. Gibson et al. Poster presented at the 40th Annual Meeting of the International Society for the Study of the Lumbar Spine, May 13-17, Scottsdale, AZ, USA
6. Pflugmacher et al. Poster presented at the 13th Annual Conference of the International Society for the Advancement of Spinal Surgery, April 3-5, Vancouver, Canada