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

Not Applicable

• Conditions: Degenerative Disc Disease
• Interventions: Device: treatment of degenerative disc disease using the PROW LIF

• Registration Number: NCT01850537
• Lead Sponsor: 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).

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 Timeline

• Study First Submitted: 2013-04-30
• Status Verified: 2013-05
• Study Start: 2013-05
• Study First Submitted QC: 2013-05-06
• Last Update Submitted: 2013-05-06
• Study First Posted: 2013-05-09
• Last Update Posted: 2013-05-09
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm study	treatment of degenerative disc disease using the PROW LIF	treatment of degenerative disc disease using the PROW LIF

Primary Outcome Measures

Name	Time	Method
Fusion rate	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

Trial Locations

Locations (1)

Spine Surgery Department, Meir Hospital, Israel; 🇮🇱 Kfar Saba, Israel