STUDY DESIGN: Pilot single-centre, stratified, prospective, randomized, double-blinded, parallel-group, controlled study. OBJECTIVE: To determine whether vertebral end-plate perforation after lumbar discectomy causes annulus reparation and intervertebral disc volume restoration. To determine that after 6 months there would be no clinical differences between the control and study group. SUMMARY OF BACKGROUND DATA: Low back pain is the most common long-term complication after lumbar discectomy. It is mainly caused by intervertebral disc space loss, which promotes progressive degeneration. This is the first study to test the efficiency of a previously described method (vertebral end-plate perforation) that should advocate for annulus fibrosus reparation and disc space restoration. METHODS: We selected 30 eligible patients according to inclusion and exclusion criteria and randomly assigned them to the control (no end-plate perforation) or study (end-plate perforation) group. Each patient was evaluated in 5 different periods, where data were collected [preoperative and 6-mo follow-up magnetic resonance imaging and functional outcome data: visual analogue scale (VAS) back, VAS legs, Oswestry disability index (ODI)]. Intervertebral space volume (ISV) and height (ISH) were measured form the magnetic resonance images. Statistical analysis was performed using paired t test and linear regression. P<0.05 was considered statistically significant. RESULTS: We found no statistically significant difference between the control group and the study group concerning ISV (P=0.6808) and ISH (P=0.8981) 6 months after surgery. No statistically significant differences were found between ODI, VAS back, and VAS legs after 6 months between the 2 groups, however, there were statistically significant differences between these parameters in different time periods. Correlation between the volume of disc tissue removed and preoperative versus postoperative difference in ISV was statistically significant (P=0.0020). CONCLUSIONS: The present study showed positive correlation between the volume of removed disc tissue and decrease in postoperative ISV and ISH. There were no statistically significant differences in ISV and ISH between the group with end-plate perforation and the control group 6 months after lumbar discectomy. Clinical outcome and disability were significantly improved in both groups 3 and 6 months after surgery.
RCT Entities:
STUDY DESIGN: Pilot single-centre, stratified, prospective, randomized, double-blinded, parallel-group, controlled study. OBJECTIVE: To determine whether vertebral end-plate perforation after lumbar discectomy causes annulus reparation and intervertebral disc volume restoration. To determine that after 6 months there would be no clinical differences between the control and study group. SUMMARY OF BACKGROUND DATA: Low back pain is the most common long-term complication after lumbar discectomy. It is mainly caused by intervertebral disc space loss, which promotes progressive degeneration. This is the first study to test the efficiency of a previously described method (vertebral end-plate perforation) that should advocate for annulus fibrosus reparation and disc space restoration. METHODS: We selected 30 eligible patients according to inclusion and exclusion criteria and randomly assigned them to the control (no end-plate perforation) or study (end-plate perforation) group. Each patient was evaluated in 5 different periods, where data were collected [preoperative and 6-mo follow-up magnetic resonance imaging and functional outcome data: visual analogue scale (VAS) back, VAS legs, Oswestry disability index (ODI)]. Intervertebral space volume (ISV) and height (ISH) were measured form the magnetic resonance images. Statistical analysis was performed using paired t test and linear regression. P<0.05 was considered statistically significant. RESULTS: We found no statistically significant difference between the control group and the study group concerning ISV (P=0.6808) and ISH (P=0.8981) 6 months after surgery. No statistically significant differences were found between ODI, VAS back, and VAS legs after 6 months between the 2 groups, however, there were statistically significant differences between these parameters in different time periods. Correlation between the volume of disc tissue removed and preoperative versus postoperative difference in ISV was statistically significant (P=0.0020). CONCLUSIONS: The present study showed positive correlation between the volume of removed disc tissue and decrease in postoperative ISV and ISH. There were no statistically significant differences in ISV and ISH between the group with end-plate perforation and the control group 6 months after lumbar discectomy. Clinical outcome and disability were significantly improved in both groups 3 and 6 months after surgery.