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

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ClinicalTrials.gov Identifier: NCT01850537
Recruitment Status : Unknown
Verified May 2013 by NLT Spine.
Recruitment status was:  Not yet recruiting
First Posted : May 9, 2013
Last Update Posted : May 9, 2013
Sponsor:
Information provided by (Responsible Party):
NLT Spine

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 Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 15 participants
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 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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 Name: PROW LIF Procedure




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01850537


Contacts
Contact: Josef Leitner, MD DR. +972-9-7472590 leitner@clalit.org.il
Contact: Orly Schwartz, B.Sc +972-3-6344514 ext 218 orly.s@nlt-spine.com

Locations
Israel
Spine Surgery Department, Meir Hospital, Israel Not yet recruiting
Kfar Saba, Israel
Contact: Joseph Leitner, MD Dr.    +972- 97472590    leitner@clalit.org.il   
Principal Investigator: Joseph Leitner, MD Dr.         
Sponsors and Collaborators
NLT Spine
Investigators
Principal Investigator: Joseph Leitner, MD Dr. Head of the Spine surgery department, Meir Hospital

Additional Information:
Responsible Party: NLT Spine
ClinicalTrials.gov Identifier: NCT01850537     History of Changes
Other Study ID Numbers: CLN0171
First Posted: May 9, 2013    Key Record Dates
Last Update Posted: May 9, 2013
Last Verified: May 2013

Keywords provided by NLT Spine:
DDD
PROW
FUSION
eSPIN
Cage
IBF
Discectomy
Lumbar Fusion
TLIF
MIS

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases