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Status unknownNCT01850537Updated May 9, 2013

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

An interventional study of treatment of degenerative disc disease using the PROW LIF in Degenerative Disc Disease, sponsored by NLT Spine. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-05-09.

Sponsored by NLT Spine · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2013), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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).

Read the 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.
02

Conditions studied

  • Degenerative Disc Disease

Keywords

  • DDD
  • PROW
  • FUSION
  • eSPIN
  • Cage
  • IBF
  • Discectomy
  • Lumbar Fusion
  • TLIF
  • MIS
03

In context

Intervertebral Disc Degeneration

464 studies on the registry are indexed under Intervertebral Disc Degeneration; 98 are open to participants now.

This study's planned enrollment of 15 is below the median of 60 across 261 interventional studies indexed under Intervertebral Disc Degeneration.

Browse Intervertebral Disc Degeneration studies →

Lead sponsor

This is the only study on the registry with NLT Spine as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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;

    -

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    single arm study

    treatment of degenerative disc disease using the PROW LIF

    Device: treatment of degenerative disc disease using the PROW LIF

Interventions

  • Devicetreatment of degenerative disc disease using the PROW LIF

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

    Also known as: PROW LIF Procedure

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 24 months follow up

07

Study locations

1 site
  • Spine Surgery Department, Meir Hospital, Israel
    Kfar Saba, Israel
    • Joseph Leitner, MD Dr. · Contact · leitner@clalit.org.il · +972- 97472590
    • Joseph Leitner, MD Dr. · Principal investigator
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01850537
Lead sponsor
NLT Spine
Responsible party
Sponsor
First posted
May 9, 2013
Start date
May 2013
Primary completion
Dec 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
May 9, 2013

Study contacts

Josef Leitner, MD DR.
Contact
leitner@clalit.org.il
+972-9-7472590
Orly Schwartz, B.Sc
Contact
orly.s@nlt-spine.com
+972-3-6344514 ext. 218
Joseph Leitner, MD Dr.
principal investigator · Head of the Spine surgery department, Meir Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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