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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01850537

Enrollment

Registered

2013-05-09

Start date

2013-05-31

Completion date

2016-12-31

Last updated

2013-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Disc Disease

Keywords

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

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.

Interventions

DEVICEtreatment of degenerative disc disease using the PROW LIF

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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; \-

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Israel

Contacts

Primary ContactJosef Leitner, MD DR.

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

Backup ContactOrly Schwartz, B.Sc

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026