Single-center Prospective Clinical Study of Intelligent Pneumatic Splint for Unstable Colles Fractures
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摘要:
目的 通过单中心的临床随机对照, 进行前瞻性研究, 探究智能气囊夹板相比普通夹板治疗不稳定型Colles骨折的有效性及安全性。 方法 研究纳入157例不稳定型Colles骨折患者, 其中对照组127例使用普通夹板, 治疗组30例使用智能气囊夹板。随访6周, 观察对比2组掌倾角和尺偏角、Lidstrom影像学评分、Gartland-Werley临床功能评分、VAS疼痛评分、夹板调整次数和骨折再复位次数等指标, 并统计2组并发症发生率。 结果 第28、42天时VAS疼痛评分比较差异有统计学意义(P < 0.05);智能气囊夹板再调整次数和骨折再复位次数更少, 差异有统计学意义(P < 0.05)。各时间点2组尺桡骨掌倾角、尺偏角和Lidstrom影像学评分、Gartland-Werley临床功能评分方面无统计学差异(P>0.05)。治疗组患者皮肤和软组织并发症区域面积显著低于对照组(P < 0.05)。 结论 智能气囊夹板在减轻Colles骨折断端疼痛、减少夹板调整次数与骨折再复位次数方面优于普通夹板, 且其压力智能调节显著降低了固定局部的并发症发生率, 值得临床尝试推广使用。 Abstract:OBJECTIVE To investigate the efficacy and safety of intelligent pneumatic splints compared with common splints in the treatment of unstable Colles fractures in a single-center, randomized, controlled, prospective study. METHODS A total of 157 patients with unstable Colles fractures were included in the study, 127 of whom were splinted with common splints while 30 of whom were splinted with intelligent pneumatic ones. At 6 weeks of follow-up, the palmar inclination and ulnar deviation angles, Lidstrom imaging score, Gartland-Werley clinical function score, VAS pain score, as well as the number of splint adjustments and fracture resets were compared between the two groups. In addition, the complication rates of both groups were counted. RESULTS There was a statistically significant difference in VAS pain scores at 28 and 42 days (P < 0.05). The number of intelligent pneumatic splint readjustments and fracture resets was fewer, and the difference was statistically significant (P < 0.05). However, there was no statistically significant difference in the ulnar and radial palm inclination angle, ulnar deviation angle, Lidstrom imaging score, as well as Gartland-Werley clinical function score between both groups at each follow-up time point (P>0.05). The skin and soft tissue complication area was significantly less in the treatment group than in the control group (P < 0.05). CONCLUSION The intelligent pneumatic splint is better than the common splint in reducing the pain of Colles fracture, and reducing the number of splint adjustments and fracture resets. Besides, its intelligent pressure adjustment significantly reduces the incidence of local complications of fixation, which is worthy of clinical application. -
Key words:
- pneumatic splint /
- Colles fracture /
- clinical study
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表 1 2组各随访时间点掌倾角比较(x±s, °)
Table 1. Comparison of palmar inclination angles between both groups at each follow-up time point(x±s, °)
组别 例数 初诊 复位即刻 复位7 d 复位14 d 复位28 d 复位42 d 治疗组 30 10.35±17.70 10.71±3.58 10.00±4.99 9.14±6.06 8.88±6.18 9.36±6.37 对照组 127 11.47±17.92 11.81±4.11 11.18±8.05 8.54±11.34 9.85±10.91 9.69±9.09 
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表 2 2组各随访时间点尺偏角比较(x±s, °)
Table 2. Comparison of ulnar deviation angles between both groups at each follow-up time point(x±s, °)
组别 例数 初诊 复位即刻 复位7 d 复位14 d 复位28 d 复位42 d 治疗组 30 16.24±8.27 22.35±3.13 20.94±2.82 19.86±2.54 21.71±2.93 21.93±2.34 对照组 127 22.07±4.50 21.47±2.88 20.91±4.28 21.60±5.59 20.69±3.94 21.09±4.09
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表 3 2组各随访时间点桡骨短缩情况比较(x±s, mm)
Table 3. Comparison of radial shortening in both groups at each follow-up time point(x±s, mm)
组别 例数 初诊 复位即刻 复位7 d 复位14 d 复位28 d 复位42 d 治疗组 30 8.29±5.82 1.88±2.26 1.44±1.82 1.79±2.12 1.59±1.84 1.57±1.95 对照组 127 8.13±6.38 1.93±2.05 1.91±1.87 2.80±4.15 2.08±2.87 2.08±2.78
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表 4 2组各随访时间点Lidstrom腕部X线指标积分比较(x±s)
Table 4. Comparison of Lidstrom's wrist X-ray index scores in both groups at each follow-up time point(x±s)
组别 例数 初诊 复位即刻 复位7 d 复位14 d 复位28 d 复位42 d 治疗组 30 5.21±1.40 1.88±2.06 1.50±1.71 1.83±2.17 1.76±1.86 1.57±1.79 对照组 127 4.13±1.60 1.20±1.26 2.00±1.63 1.62±0.89 1.23±1.74 1.24±0.47
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表 5 2组各随访时间点Gartland-Werley临床功能评分比较(x±s)
Table 5. Comparison of Gartland-Werley clinical function scores between both groups at each follow-up time point(x±s)
组别 例数 复位28 d 复位42 d 治疗组 30 8.95±1.60 3.64±1.26 对照组 127 10.01±1.61 4.55±1.29
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表 6 2组各随访时间点VAS疼痛评分比较(x±s)
Table 6. Comparison of VAS pain scores between both groups at each follow-up time point(x±s)
组别 例数 初诊 复位即刻 复位7 d 复位14 d 复位28 d 复位42 d 治疗组 30 7.32±1.50 6.50±1.70 4.69±1.24 4.42±1.26 2.68±0.68# 1.71±0.67# 对照组 127 7.31±1.17 6.59±1.27 5.69±1.61 5.70±1.15 3.67±1.11 2.69±0.75 注: 组间比较, #P < 0.05。
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表 7 2组各随访时间点夹板调整、再复位次数和皮肤并发症面积比较(x±s)
Table 7. Comparison of the number of splint adjustment and fracture resets, combined with the area of skin complications between both groups at each follow-up time point(x±s)
组别 例数 夹板调整次数 骨折再复位次数 皮肤并发症面积/cm2 治疗组 30 1.41±0.51# 0.18±0.39# 4.90±2.09## 对照组 127 2.53±0.92 0.53±0.52 18.55±3.56 注: 组间比较, #P < 0.05, ##P < 0.01。
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