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

NCT01850537 | Unknown

• 1 other identifier: CLN0171
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Degenerative Disc Disease

Keywords

DDD; PROW; FUSION; eSPIN; Cage; IBF; Discectomy; Lumbar Fusion; TLIF; MIS

Outcome Measures

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

  24 months follow up

Study Arms (1)

single arm study

EXPERIMENTAL

treatment of degenerative disc disease using the PROW LIF

Device: treatment of degenerative disc disease using the PROW LIF

Interventions

treatment of degenerative disc disease using the PROW LIF DEVICE

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

Also known as: PROW LIF Procedure

single arm study

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• NLT Spine: lead

Study Sites (1)

Spine Surgery Department, Meir Hospital, Israel

Kfar Saba, Israel

Location

Related Links

• NLT SPINE website

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Joseph Leitner, MD Dr.

  Head of the Spine surgery department, Meir Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Josef Leitner, MD DR.

CONTACT

+972-9-7472590; leitner@clalit.org.il

Orly Schwartz, B.Sc

CONTACT

+972-3-6344514; orly.s@nlt-spine.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2013
• First Posted: May 9, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 9, 2013

Record last verified: 2013-05

Locations

IL (1)