目的:探讨聚醚醚酮(PEEK)棒半刚性椎弓根螺钉内固定系统在腰椎非融合手术中的应用效果。
方法:将2017年3月至2019年12月接受手术治疗的74例腰椎退行性疾病患者分为PEEK棒组和钛棒组。在PEEK棒组中,有34个病人,包括13名男性和21名女性,年龄51~79岁,平均(62.4±6.8)岁;L1-L3节段1例,7名L2-L4节段患者,20名L3-L5节段患者和6名L4-S1节段患者。在钛棒组中,有40个病人,包括17名男性和23名女性,年龄52~81岁,平均(65.2±7.3)岁;3例L1-L3节段,11例L2-L4节段患者,19名L3-L5节段患者和7名L4-S1节段患者。操作的一般条件,例如操作时间,术中失血,记录术后引流量.术前和术后比较下腰痛的视觉模拟评分(VAS)和Oswestry残疾指数(ODI)(3个月,12个月和最后一次随访)。通过腰椎屈伸X线观察运动范围(ROM)的变化。
结果:所有患者均顺利完成手术。随访时间22~34个月,平均(26.8±5.6)个月。PEEK组手术时间(142.2±44.7)min、术中出血量(166.5±67.4)ml均低于钛组[(160.7±57.3)min、(212.8±85.4)ml](P<0.05)。两组术后引流量比较差异无统计学意义(P>0.05)。在最后的后续访问中,PEEK组和钛组腰背痛的VAS[(0.8±0.4)分vs(1.0±0.5)分],腿部疼痛的VAS[(0.7±0.4)点vs(0.8±0.5)点]和ODI[(9.8±1.6)%vs(12.1±1.5)%]与术前[(5.8±1.1)点vs(6.0±1.1)点]进行比较。[(7.2±1.7)点对(7.0±1.6)点],[(68.5±8.9)%与(66.3±8.2)%]差异有统计学意义(P<0.05)。两组术后各时间点VAS评分比较差异无统计学意义(P>0.05)。手术后3个月,两组ODI比较差异无统计学意义(P>0.05)。PEEK组与钛棒组的ODI在12个月时[(15.5±2.1)%vs(18.4±2.4)%]和末次随访时[(9.8±1.6)%vs(12.1±1.5)%]差异有统计学意义(P<0.05)。两组术后腰椎总活动度(ROM)均下降。在手术后12个月和最后一次随访时,PEEK组与钛棒组相比,腰椎总活动度差异有统计学意义(P<0.05)。手术后两组固定节段的运动范围(ROM)均降低。末次随访时PEEK组固定节段的ROM由(9.5±4.6)°下降至(4.1±1.9)°(P<0.05),钛棒组末次随访时从(9.8±4.3)°降至(0.9±0.5)°(P<0.05)。两组上相邻段的运动范围(ROM)均增加,两组患者术后12个月与末次随访时的上相邻段ROM差异有统计学意义,(P<0.05)。随访期间两组均未出现螺钉松动和断棒。
结论:PEEK杆半刚性椎弓根螺钉内固定系统应用于腰椎非融合手术,可以保留部分固定段的活动性,显示出与钛棒融合相当的短期临床疗效。PEEK棒半刚性椎弓根螺钉内固定系统是治疗腰椎退行性疾病的可行选择,其远期疗效有待进一步随访观察。
OBJECTIVE: To investigate the effect of Polyetheretherketone (PEEK) rod semi-rigid pedicle screw fixation system in lumbar spine non-fusion surgery.
METHODS: A total of 74 patients with tow-level lumbar degenerative diseases who underwent surgery from March 2017 to December 2019 were divided into PEEK rod group and titanium rod group. In the PEEK rod group, there were 34 patients, including 13 males and 21 females, aged from 51 to 79 years old with an average of (62.4±6.8) years old;There were 1 patient of L1-L3 segments, 7 patients of L2-L4 segments, 20 patients of L3-L5 segments and 6 patients of L4-S1 segments. In the titanium rod group, there were 40 patients, including 17 males and 23 females, aged from 52 to 81 years old with an average of (65.2±7.3) years old;There were 3 patient of L1-L3 segments, 11 patients of L2-L4 segments, 19 patients of L3-L5 segments and 7 patients of L4-S1 segments. The general conditions of operation, such as operation time, intraoperative blood loss, postoperative drainage was recorded. The visual analogue scale (VAS) for low back pain and Oswestry disability index (ODI) were compared in preoperatively and postoperatively(3 months, 12 months and last follow-up) between two groups. The change of range of motion (ROM) was observed by flexion and extension x-ray of lumbar.
RESULTS: All patients successfully completed the operation. The follow-up time ranged from 22 to 34 months with an average of(26.8±5.6) months. The operative time (142.2±44.7) min and intraoperative blood loss(166.5±67.4)ml in PEEK group were lower than those in titanium group [(160.7±57.3) min、(212.8±85.4) ml](P<0.05). There was no significant differences in postoperative drainage between the two groups (P>0.05). At the final follow-up visit, in PEEK group and titanium group VAS of low back pain[(0.8±0.4) points vs (1.0±0.5) points], VAS for leg pain [ (0.7±0.4) points vs (0.8±0.5) points] and ODI [(9.8±1.6)% vs (12.1±1.5)%] were compared with preoperative [ (5.8±1.1) points vs (6.0±1.1)points], [ (7.2±1.7) points vs (7.0±1.6) points], [(68.5±8.9)% vs(66.3±8.2)%] were significantly different(P<0.05). There was no significant difference in VAS scores between the two groups at each postoperative time point (P>0.05). At 3 months after surgery, there was no difference in ODI between the two groups (P>0.05). There were significant differences in ODI between PEEK group and titanium rod group at 12 months [(15.5±2.1)% vs (18.4±2.4)%] and at the last follow-up [(9.8±1.6)% vs (12.1±1.5)%] (P<0.05). The total range of motion (ROM) of lumbar decreased in both groups after surgery. At 12 months after surgery and the last follow-up, the PEEK group compared with the titanium rod group, the total range of motion of lumbar was statistically significant (P<0.05). The range of motion (ROM) of the fixed segments decreased in both groups after surgery. The ROM of the fixed segments in PEEK group decreased from (9.5±4.6)° to (4.1±1.9)° at the last follow-up (P<0.05), which in the titanium rod group was decreased from (9.8±4.3)°to (0.9±0.5)° at the last follow-up (P<0.05). The range of motion (ROM) of upper adjacent segment increased in both groups, there was statistical significance in the ROM of upper adjacent segment between the two groups at 12 months after surgery and the last follow-up, (P<0.05). There was no screw loosening and broken rods in both groups during the follow-up period.
CONCLUSIONS: The PEEK rod semi-rigid pedicle screw internal fixation system used in lumbar non-fusion surgery can retain part of the mobility of the fixed segment, showing comparable short-term clinical efficacy to titanium rod fusion. PEEK rod semi-rigid pedicle screw internal fixation system is a feasible choice for the treatment of lumbar spine degenerative diseases, and its long-term efficacy needs further follow-up observation.