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

Primary Purpose

Degenerative Disc Disease

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
treatment of degenerative disc disease using the PROW LIF
Sponsored by
NLT Spine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Disc Disease focused on measuring DDD, PROW, FUSION, eSPIN, Cage, IBF, Discectomy, Lumbar Fusion, TLIF, MIS

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:main Inclusion Criteria

  1. Male and female between 18-65 years of age (skeletally mature).

  2. 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:

    1. instability (defined as angulation ≥ 5° and/or translation ≥ 4mm on flexion/extension radiographs);
    2. osteophyte formation;
    3. decreased disc height;
    4. ligamentous thickening;
    5. disc degeneration/herniation; or
    6. facet joint degeneration.
  3. A pre-op Oswestry Low Back Pain Disability Questionnaire (ODI) score of 35 % or more;

  4. Be non-responsive to non-operative treatment for at least 6 months;

    -

Exclusion Criteria:

  1. The Antero-Posterior (AP) diameter (at midline) of the involved level is <31mm.
  2. Any previous spinal surgery at the involved level;
  3. Spondylolisthesis > grade I;
  4. Ankylosed segment at the affected level;
  5. History or radiographic evidence of osteoporotic fractures in the spine;
  6. Paraparesis;

  7. Progressive neurologic conditions;

    -

Sites / Locations

  • Spine Surgery Department, Meir Hospital, Israel

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single arm study

Arm Description

treatment of degenerative disc disease using the PROW LIF

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 30, 2013
Last Updated
May 6, 2013
Sponsor
NLT Spine
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1. Study Identification

Unique Protocol Identification Number
NCT01850537
Brief Title
Prospective Study To Assess The Safety and Efficacy of the PROW LIF Procedure
Official Title
Prospective Study To Assess The Safety and Efficacy of the PROW LIF Procedure
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NLT Spine

4. Oversight

Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease
Keywords
DDD, PROW, FUSION, eSPIN, Cage, IBF, Discectomy, Lumbar Fusion, TLIF, MIS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
single arm study
Arm Type
Experimental
Arm Description
treatment of degenerative disc disease using the PROW LIF
Intervention Type
Device
Intervention Name(s)
treatment of degenerative disc disease using the PROW LIF
Other Intervention Name(s)
PROW LIF Procedure
Intervention Description
TLIF procedure for the treatment of degenerative disc disease using the PROW LIF procedure (system)
Primary Outcome Measure Information:
Title
Fusion rate
Description
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
Time Frame
24 months follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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; 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; -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Josef Leitner, MD DR.
Phone
+972-9-7472590
Email
leitner@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Orly Schwartz, B.Sc
Phone
+972-3-6344514
Ext
218
Email
orly.s@nlt-spine.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Leitner, MD Dr.
Organizational Affiliation
Head of the Spine surgery department, Meir Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spine Surgery Department, Meir Hospital, Israel
City
Kfar Saba
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Leitner, MD Dr.
Phone
+972- 97472590
Email
leitner@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Joseph Leitner, MD Dr.

12. IPD Sharing Statement

Links:
URL
http://www.nlt-spine.com
Description
NLT SPINE website

Learn more about this trial

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

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