Article Figures & Data
Figures
- Fig. 1
M6-L Components & Finished Device.
- Fig. 2
Mean Oswestry Disability Index. *p < 0.001. There was a significant difference between the SL and ML groups at both Pre-Op and 24 months (p < 0.05).
- Fig. 3
Disability Level at baseline and 24 Months for the Single Level patients.
- Fig. 4
Disability Level at baseline and 24 Months for the Multi-Level Patients.
- Fig. 5
Back Pain VAS at Baseline and 24 Months for the Single Level (SL), Multi Level (ML), and Combined (C) datasets. *p < 0.001. There was no significant difference between the two cohorts at either pre-op or 24 months.
- Fig. 6
Lateral radiographs of the lumbar spine including the index level, for single level disc replacement at L5/S1.
- Fig. 7
Lateral radiographs of the lumbar spine including the index level, for two level disc replacement at L4/L5 and L5/S1.
- Fig. 8
Disc Angle for the single level and multi-level cases at L4-L5 and L5-S1. * p < 0.05.
Tables
Key Inclusion Criteria: Between 18 and 75 years of age
Treatment at one or two adjacent levels between L3 and S
Have not responded to at least 6 months of non-operative, conservative management
Have symptomatic degenerative disc disease (DDD) demonstrated by signs and/or symptoms of disc herniation, osteophyte formation, or loss of disc height
Key Exclusion Criteria: Osteopenia or osteoporosis
Have a history of endocrine or metabolic disorders. Have rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV or active hepatitis.
Prior intra-abdominal or retroperitoneal surgery that would make the approach prohibitively dangerous, or prior anterior surgery at the same level
Have uncontrolled insulin dependent type 1 or type 2 diabetes
Require a treatment (e.g., posterior element decompression) that destabilizes the spine.
Isolated radicular compression syndromes, especially due to disc herniation
Bony lumbar stenosis, pars defect, increased segmental instability, spinal deformities, spondylolisthesis above 3mm at the involved level(s)
Radiological confirmation of severe facet joint disease or degeneration
All patients Single Level Multiple Levels Gender: Female
Male48 (58%)
35 (42%)31 (63%)
18 (37%)17 (50%)
17 (50%)Age in years (Mean ± SD) 42.1 ± 8.2 43.6 ± 7.5 40.1 ± 8.8 Height in cm (Mean ± SD) 172.0 ± 9.6 171.0 ± 9.4 173.3 ± 9.9 Weight in kg (Mean ± SD) 76.5 ± 17.4 76.2 ± 17.7 77.0 ± 17.1 BMI (Mean ± SD) 25.7 ± 4.5 25.9 ± 4..6 25.4 ± 4.4 Surgery Time in min (Mean ± SD) 79.4 ± 30.6 127.5 ± 52.9 Blood loss (cc) (Mean) 180.3 359.4 Mean Hospital Stay in days (Mean) 5.7 6.4 (6.0) Note: Age, height, weight, BMI and surgery time were available for 98% of patients. Blood loss and hospital stay were available for 89% of patients.
All patients Index Level(s) n (%) of pts L4/L5 12 (14.5%) L5/S1 37 (44.6%) L2/L3; L3/L4* 1 (1.2%) L3/L4; L4/L5 5 (6.0 %) L3/L4; L5/S1 1(1.2%) L4/L5; L5/S1 23 (27.7%) L3/L4; L4/L5; L5/S1* 4 (4.8%) ↵* Although the IFU for the M6-L device indicates implantation of the device at 1 or 2 levels from L3 – S1, the decision to implant the device at L2/3 was made for 1 patient and the decision to implant at 3 levels was made for 4 patients.
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