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

May 6, 2013 updated by: NLT Spine
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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Kfar Saba, Israel
        • Spine Surgery Department, Meir Hospital, Israel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NLT Spine

Investigators

  • Principal Investigator: Joseph Leitner, MD Dr., Head of the Spine surgery department, Meir Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

April 30, 2013

First Submitted That Met QC Criteria

May 6, 2013

First Posted (Estimate)

May 9, 2013

Study Record Updates

Last Update Posted (Estimate)

May 9, 2013

Last Update Submitted That Met QC Criteria

May 6, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN0171

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Degenerative Disc Disease

Clinical Trials on treatment of degenerative disc disease using the PROW LIF

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe