LimiFlex Clinical Trial for the Treatment of Degenerative Spondylolisthesis With Spinal Stenosis

Summary

The LimiFlex™ Clinical Trial is a prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of decompression and stabilization with the Empirical Spine LimiFlex™ Paraspinous Tension Band compared to decompression and transforaminal lumbar interbody fusion (TLIF) with concomitant posterolateral fusion (PLF) for the treatment of lumbar degenerative spondylolisthesis (Grade I per Meyerding classification) with spinal stenosis. Clinical trial sites will enroll solely LimiFlex subjects or solely TLIF/PLF subjects.

Conditions

• Degenerative Spondylolisthesis
• Lumbar Spinal Stenosis

Interventions

DEVICE

LimiFlex

LimiFlex implantation at a single level after surgical decompression.

DEVICE

Fusion Instrumentation

Titanium alloy top-loading, polyaxial pedicle screws and cylindrical, titanium alloy rod instrumentation using autograft and/or allograft bone (i.e., cancellous and/or corticocancellous bone only), and/or a synthetic bone graft extender that is on-label for these indications (i.e., decorticated posterolateral gutter only). The TLIF requires a single PEEK or Titanium TLIF cage cleared by FDA for this indication filled with autograft and/or allograft bone (i.e., cancellous and/or corticocancellous bone only).

PROCEDURE

Decompression

Surgical decompression at one or two contiguous levels from L1 to S1.

PROCEDURE

Fusion

Transforaminal lumbar interbody fusion (TLIF) with concomitant posterolateral fusion (PLF) at a single level after surgical decompression.

Sponsors & Collaborators

• Biomedical Statistical Consulting

  collaborator UNKNOWN

• Medical Metrics Diagnostics, Inc

  collaborator INDUSTRY

• MCRA

  collaborator INDUSTRY

• Empirical Spine, Inc.

  lead INDUSTRY

Principal Investigators

• Rick Sasso, MD · Indiana Spine Group

• William C Welch, MD · Pennsylvania Hospital Neurosurgery

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-07-17

Primary Completion

2025-12-30

Completion

2026-01-16

FDA Device

Yes

Countries

• United States

Study Locations