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

Sponsor

NLT Spine (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01850537

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Degenerative Disc Disease	Device: treatment of degenerative disc disease using the PROW LIF	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: single arm study treatment of degenerative disc disease using the PROW LIF	Device: treatment of degenerative disc disease using the PROW LIF TLIF procedure for the treatment of degenerative disc disease using the PROW LIF procedure (system) Other Names: PROW LIF Procedure

Arm

Intervention/Treatment

Experimental: single arm study

treatment of degenerative disc disease using the PROW LIF

Device: treatment of degenerative disc disease using the PROW LIF

TLIF procedure for the treatment of degenerative disc disease using the PROW LIF procedure (system)

Other Names:

PROW LIF Procedure

Outcome Measures

Primary Outcome Measures

Fusion rate [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;