Article Figures & Data
Figures
- Fig. 1
Physio-L artificial lumbar disc.
- Fig. 2
Lateral radiographs showing A) a patient implanted with a single Physio-L at L5-S1, and B) a patient implanted with two Physio-L devices at L4-L5 and L5-S1 at the 12 month follow up time point.
- Fig. 3
Mean ODI scores at all follow up evaluations. Error bars indicate standard deviations. * indicates statistically significant differences (p < 0.05) from the pre-operative scores. The dotted line indicates the minimal clinically important difference (MCID) of a 10 point decrease from the pre-operative score.
- Fig. 4
VAS scores at all follow up evaluations. Error bars indicate standard deviations. * indicates statistically significant differences (p < 0.05) from the pre-operative scores. The dotted line indicates the MCID of an 18 point decrease from the pre-operative score.
- Fig. 5
Mean SF-36 scores at all follow up evaluations. Error bars indicate standard deviations.
- Fig. 6
Comparison of the clinical outcomes for the Physio-L versus the Charite, ProDisc-L, and Fusion for A) ODI scores and, B) VAS low back pain scores.
Tables
Inclusion Exclusion Skeletally mature (age, 18 –70)
BMI <35
Degenerative Disc Disease at or levels between L3-S1 confirmed by: 1) Self reports of greater amount of back pain compared with leg pain; 2) MRI or discography with concordant pain within 6 months.
Self reports preoperative Visual Analog Scale score for back pain ≥40%
Self reports preoperative Oswestry Disability Index score 40%
Documented symptoms for minimum of months
Patient is competent and has signed the informed consentSymptomatic DDD at more than levels between L3-S1.
Patient has experienced previous abdominal surgeries which could compromise surgical exposure.
Patient is pregnant or seeking to become pregnant during the study.
Previous diagnosed Paget's disease, osteomalacia, other metabolic bone disease or is insulin-dependent.
Bone density measurements indicating osteopenia or osteoporosis (DEXA score of −1 or less)
Significant facet joint arthritis
Active infection
Chronic steroid use
Known history of metal or plastic allergy
Spondylolysis at index level
Active malignancy
Spinal tumor
Previously diagnosed autoimmune disorders or immune compromised
Spondylolysthesis ≥ 3mm (Grade 1)
Significant instability ≥ 3mm indicated by F/radiograph
Lumbar scoliosis > 10%
Mid-sagittal stenosis < 11mm (by CT or MRI)
Prior fusion adjacent to the index level.
Positive single or bilateral straight leg raise test.
Previous surgical procedures at the index level that would preclude the placement of the device such as extensive posterior decompression procedures.
Current treatment for psychosocial disorders (eg, chemical dependence).
Currently smoker.
Return visits burdensome to patient.
Currently participating in another investigational study that could interfere with the outcome measurements of this study.Number of levels treated Operative time (min) Blood loss (cc) Single level 135.0 ± 32.1 303 ± 315 Single level Two levels 202.5 ± 37.7 713 ± 864 - Table 3
Range of motion pre-operatively and at the 12 month follow up evaluation for operative and adjacent levels
Description Operative level Adjacent levels Total ROM, baseline 12.0° 6.2° 10.8° 5.5° Total ROM, 12-month follow-up 13.3° 5.5° 13.3° 5.0° Operative level Preop DH (mm) Baseline DH (mm) ΔDH, preop to baseline ΔDH, baseline to 12-month follow-up L4-(4) (n = 4) 8.5 ± 2.7 13.9 ± 1.6 5.4 mm 0.1 mm L5-S1 (n = 12) 8.7 ± 1.5 15.7 ± 1.4 7.0 mm −0.6 mm
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