Status:
UNKNOWN
Prospective Study To Assess The Safety and Efficacy of the PROW LIF Procedure
Lead Sponsor:
NLT Spine
Conditions:
Degenerative Disc Disease
Eligibility:
All Genders
18-65 years
Phase:
NA
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...
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....
Eligibility Criteria
Inclusion
- main Inclusion Criteria
- 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;
- \-
Exclusion
- 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;
- \-
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01850537
Start Date
May 1 2013
End Date
December 1 2016
Last Update
May 9 2013
Active Locations (1)
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1
Spine Surgery Department, Meir Hospital, Israel
Kfar Saba, Israel