Safety and Efficacy of the CarboClear Pedicle Screw System (NCT02626624) | Clinical Trial Compass
CompletedNot Applicable
Safety and Efficacy of the CarboClear Pedicle Screw System
United States57 participantsStarted 2015-12-27
Plain-language summary
The purpose of this trial is to demonstrate the safety and effectiveness of the CarboClear Pedicle Screw System, for skeletally mature DDD patients undergoing one level spinal fusion in combination with interbody fusion device, and requiring immediate, rigid, posterior spinal stabilization of the lumbar and/or sacral spine.
Who can participate
Age range21 Years – 72 Years
SexALL
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Inclusion criteria
✓. Subject has degenerative disc disease (DDD) at one level, from L2 to S1 vertebrae, with up to Grade I spondylolisthesis.
✓. Subject is candidate for single level intervertebral fusion, with or without posterolateral fusion, with implantation of intervertebral body fusion device and supplemental fixation.
✓. Subject age is between 21 - 72 years, and subject is skeletally mature.
✓. Pre-operative low back and/or leg/s pain (debilitating pain that causes a significant disturbance of the routine daily physical activities) ≥ 40 mm on a 100 mm Visual Analogue Scale (VAS).
✓. Pre-operative Oswestry Disability Index (ODI) score ≥ 40 percentage-point, indicating at least moderate disability (interpreted as moderate/severe disability).
✓. Low back and/or leg/s pain is unresponsive to prior non-surgical management for a minimum of six months. Non-operative treatment includes pain medication, physical therapy and/or injections.
✓. Patient must understand and sign the informed consent.
✓. Patient is willing and able to meet the proposed follow-up schedule including return to follow-up visits and complete necessary study paperwork.
Exclusion criteria
✕. Previous fusion or fusion attempts, including anterior fusion or posterolateral fusion, at the index level.
✕. Previous fusion or fusion attempts at the adjacent levels.
What they're measuring
1
Fusion: Evaluated Radiographically (by AP, Lateral and Flexion/Extension X-Rays) by Independent Radiographic Core Lab.
Timeframe: 24 months
2
Pain (Low Back and/or Leg/s): Assessed Based on Visual Analogue Scale (VAS) Patient Questionnaire
Timeframe: 24 months
3
Function: Assessed by Oswestry Disability Index (ODI) Patient Questionnaire
Timeframe: 24 months
4
Safety: Neurological Deterioration, Device Related Serious Adverse Events, Additional Surgical Intervention at Index Level.
. Prior decompression procedures that include removal of soft and bone tissue at the index or adjacent levels.
✕. Patient is not skeletally mature.
✕. Degenerative spondylolisthesis greater than Grade I.
✕. Spinal instability at the index level with ≥ 3 mm translation and/or ≥ 5 degrees angulation. Determination of instability will be assessed using flexion/extension lateral view radiographs.
✕. Isthmic spondylolisthesis.
✕. Radiographically confirmed moderate or severe spinal stenosis with associated neurogenic claudication. Radiographically confirmed moderate/severe stenosis is defined as reduction of ˃50% of central and/or foraminal canal diameter compared to the adjacent uninvolved levels. Neurogenic claudication is leg, groin or buttock pain and/or numbness that worsens with walking or erect posture and is relieved with flexion of the spine.