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

NCT ID: NCT01850537

Last Updated: 2013-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2016-12-31

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.

Conditions

Degenerative Disc Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single arm study

treatment of degenerative disc disease using the PROW LIF

Group Type: EXPERIMENTAL

treatment of degenerative disc disease using the PROW LIF

Intervention Type: DEVICE

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

Interventions

treatment of degenerative disc disease using the PROW LIF

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

Intervention Type: DEVICE

Other Intervention Names

PROW LIF Procedure

Eligibility Criteria

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;

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NLT Spine

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph Leitner, MD Dr.

Role: PRINCIPAL_INVESTIGATOR

Head of the Spine surgery department, Meir Hospital

Locations

Spine Surgery Department, Meir Hospital, Israel

Kfar Saba, , Israel

Countries

Israel

Central Contacts

Josef Leitner, MD DR.

Role: CONTACT

leitner@clalit.org.il

+972-9-7472590

Orly Schwartz, B.Sc

Role: CONTACT

orly.s@nlt-spine.com

+972-3-6344514 ext. 218

Facility Contacts

Joseph Leitner, MD Dr.

Role: primary

leitner@clalit.org.il

+972- 97472590

Related Links

http://www.nlt-spine.com

NLT SPINE website

Other Identifiers

CLN0171

Identifier Type: -

Identifier Source: org_study_id