Article Figures & Data
Figures
- Fig. 1
Mean VAS pain scores over time (preoperatively, postoperatively, and at 6 weeks and 3, 6, 12, 24, and 36 months) for each group.
- Fig. 2
Mean ODI scores over time (preoperatively and at 6 weeks and 3, 6, 12, 24, and 36 months) for each group.
Tables
Age between 18 and 60 years Evidence of degenerative disc disease at either L4–5 or L5-S1 (only 1 level) with radiographic evidence (CT, MRI, plain film, flexion/extension films, myelography, discography, and so on) of mild to moderate osteophyte formation of vertebral endplates, loss of disc height >2 mm when compared with adjacent level, herniated nucleus pulposus, loss of water content on MRI (black disc on T2-weighted image), or vacuum phenomenon History of back and/or radicular pain that is severe, ongoing, and recurrent At least 6 months of prior conservative therapy for discogenic back pain and/or prior nucleolysis, nucleoplasty, discectomy, or laminotomy (without accompanying facetotomy) at study treatment level ODI showing moderate disability VAS showing moderate disability Abbreviations: CT, computed tomography; MRI, magnetic resonance imaging.
Any back or leg pain of unknown origin Foot drop Previous trauma to the study treatment level, resulting in compression or bursting Sufficient previous surgeries that would preclude use of an anterior approach or previous retroperitoneal surgery Other spinal surgery at affected level Previous thoracic or lumbar fusion Documented spondylolisthesis with >3 mm of slippage at study level Isthmic (spondylolytic) spondylolisthesis at study level Spondylitis (ie, inflammation of spine) at study level Documented significant spinal, foraminal, or lateral stenosis at study level Disc space height ≤3 mm at study level Documented presence of free nuclear fragment at study level Extensive facet arthritis or degeneration of facets at any level noted on MRI, CT, or radiography Scoliosis of lumbar spine with >11° of coronal deformity Metabolic bone disease Active systemic infection Active malignancy or history of metastatic malignancy Any terminal or autoimmune disease Any other disease, condition, or surgery that might impair healing Recent history of chemical or alcohol dependence Current or extended use of any drug known to interfere with bone or soft-tissue healing Known metal allergy Morbid obesity (body mass index >40 or >100 lb overweight) Transitional vertebra at level to be treated that has not clearly fused Pregnancy at time of enrollment (because this would contraindicate abdominal surgery) Abbreviations: CT, computed tomography; MRI, magnetic resonance imaging.
Kineflex Disc Charité device No. of subjects 33 31 Male 15 13 Female 18 18 Age [mean (SD)] (y) 40.1 (10.01) 40.8 (7.68) Body mass index [mean (SD)] 26.6 (3.39) 26.0 (3.40) Current or former smoker 17 (51.5%) 20 (64.5%) Surgery level L4–5 6 (18%) 4 (12.9%) Surgery level L5-S1 27 (81.8%) 27 (87.1%) Kineflex mean improvement Charité mean improvement Difference (Kineflex–Charité) 95% CI P value VAS score 3-y change 59.05 68.47 −9.41 −27.3 to 8.5 .17 2-y change 56.80 54.43 2.37 −12.5 to 17.3 .004 ODI 3-y change 40.00 43.67 −3.67 −18.9 to 11.6 .2 2-y change 37.30 38.40 −1.09 −12.0 to 9.9 .054
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