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Chapter 5
Figure 1. Flow chart of enrollment and follow-up
228 assessed for eligibility
69 excluded
Not meeting inclusion criteria (n=25)
- cauda equina syndrome or big herniated disc - Paget's disease or osteoporosis or metastasis - significant scoliosis (Cobb angle >25)
- previous surgery of the same lumbar level
- degenerative spondylolisthesis > grade 1
- severe co morbid conditions
Declined to participate (n=17)
Refused due to preference for
Bony decompression (n=10)
Refused due to preference for IPD (n=16)
Died during preoperative period (n=1)
159 randomized
79 allocated to bony decompression group 79 received allocated intervention
1 lost to follow-up after one year
78 analyzed after 8 weeks (1 lost to follow-up and 1 not attend but returned later) 78 analyzed after 52 weeks (1 lost to follow-up)
80 allocated to IPD group
80 received allocated intervention
7 lost to follow-up after one year
74 analyzed after 8 weeks (6 lost to follow-up) 73 analyzed after 52 weeks (7 lost to follow-up)
78