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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).
Primary endpoints:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm study | Experimental | treatment of degenerative disc disease using the PROW LIF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| treatment of degenerative disc disease using the PROW LIF | Device | TLIF procedure for the treatment of degenerative disc disease using the PROW LIF procedure (system) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria: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:
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;
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Exclusion Criteria:
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;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Josef Leitner, MD DR. | Contact | +972-9-7472590 | leitner@clalit.org.il | |
| Orly Schwartz, B.Sc | Contact | +972-3-6344514 | 218 | orly.s@nlt-spine.com |
| Name | Affiliation | Role |
|---|---|---|
| Joseph Leitner, MD Dr. | Head of the Spine surgery department, Meir Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spine Surgery Department, Meir Hospital, Israel | Kfar Saba | Israel |
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| Label | URL |
|---|---|
| NLT SPINE website | View source |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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