Prospective Study To Assess The Safety and Efficacy of the PROW LIF Procedure
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Degenerative Disc Disease
- Sponsor
- NLT Spine
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Fusion rate
- Last Updated
- 12 years ago
Overview
Brief Summary
This is a prospective, single-arm, open-label, non-randomized study. The aim of the study is to assess the safety and efficacy of the Prow LIF procedure in Transforaminal Lumbar Interbody Fusion (TLIF) procedures for the treatment of subjects with symptomatic degenerative disc disease (DDD).
Detailed Description
Primary endpoints: * Safety: Incidence of device-related anticipated and unanticipated serious adverse events (SAE). However, ALL complications and adverse events (AE) will be monitored and recorded. * Primary radiographic effectiveness outcome parameter: evaluations of fusion rate.
Investigators
Eligibility Criteria
Inclusion Criteria
- •main Inclusion Criteria
- •Male and female between 18-65 years of age (skeletally mature).
- •Subjects suffering from degenerative disc disease (DDD) accompanied by back pain with leg pain at a single level between L2 and S1 confirmed by history and radiographic studies and that are scheduled for a fusion operation. DDD is determined to be present if one or more of the following are noted:
- •instability (defined as angulation ≥ 5° and/or translation ≥ 4mm on flexion/extension radiographs);
- •osteophyte formation;
- •decreased disc height;
- •ligamentous thickening;
- •disc degeneration/herniation; or
- •facet joint degeneration.
- •A pre-op Oswestry Low Back Pain Disability Questionnaire (ODI) score of 35 % or more;
Exclusion Criteria
- •The Antero-Posterior (AP) diameter (at midline) of the involved level is \<31mm.
- •Any previous spinal surgery at the involved level;
- •Spondylolisthesis \> grade I;
- •Ankylosed segment at the affected level;
- •History or radiographic evidence of osteoporotic fractures in the spine;
- •Paraparesis;
- •Progressive neurologic conditions;
Outcomes
Primary Outcomes
Fusion rate
Time Frame: 24 months follow up
Primary radiographic effectiveness outcome parameter: evaluations of fusion. Fusion will be evaluated at 6 months, 12 months and 24 months post-op using plain radiographs (AP, lateral and flexion/extension films) and at 24 months using CT scan as well