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

Degenerative Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01850537
• Other study ID #: CLN0171
• Status: Not yet recruiting
• Phase: N/A
• First received: April 30, 2013
• Last updated: May 6, 2013
• Start date: May 2013
• Est. completion date: December 2016

Study information

• Verified date: May 2013
• Source: NLT Spine
• Contact: Josef Leitner, MD DR.
• Phone: +972-9-7472590
• Email: leitner[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

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)

Locations

Country	Name	City	State
Israel	Spine Surgery Department, Meir Hospital, Israel	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
NLT Spine

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

•   NLT SPINE website