Prospective Study To Assess The Safety and Efficacy of the PROW LIF Procedure

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Study To Assess The Safety and Efficacy of the PROW LIF Procedure

Conditions
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Degenerative Disc Disease

Intervention / Treatment
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* Device: treatment of degenerative disc disease using the PROW LIF


Participation Criteria
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Eligibility Criteria
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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; Be non-responsive to non-operative treatment for at least 6 months; - 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; -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single arm study<br>treatment of degenerative disc disease using the PROW LIF | Device: treatment of degenerative disc disease using the PROW LIF<br>* TLIF procedure for the treatment of degenerative disc disease using the PROW LIF procedure (system)<br>* Other names: PROW LIF Procedure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fusion rate | 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 | 24 months follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DDD, PROW, FUSION, eSPIN, Cage, IBF, Discectomy, Lumbar Fusion, TLIF, MIS