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

NLT Spine

Status: Unknown

Conditions: Degenerative Disc Disease

Treatments: Device: treatment of degenerative disc disease using the PROW LIF

Study type: Interventional

Funder types: Industry

Identifiers

NCT01850537

CLN0171

Details and patient eligibility

About

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).

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

single arm study

Experimental group

Description:

treatment of degenerative disc disease using the PROW LIF

Treatment:

Device: treatment of degenerative disc disease using the PROW LIF