Rancy Schneider K, Malliaris Stephanie D, Bogner Eric A, Wolfe Scott W
SUNY Downstate Medical Center, College of Medicine, Brooklyn, New York.
Division of Hand and Upper Extremity Surgery, Denver Health Medical Center, University of Colorado School of Medicine, University of Colorado Denver, Denver, Colorado.
J Wrist Surg. 2018 Nov;7(5):358-365. doi: 10.1055/s-0038-1669438. Epub 2018 Sep 18.
CAGE-DR implant is a novel Food and Drug Administration approved intramedullary fracture fixation device used for distal radius fractures. We examine a series of 22 patients and report the outcomes with this device. A total of 24 patients with distal radius fractures (8 articular AO type C1/C2; 16 extra-articular AO type A2/A3) underwent open reduction and internal fixation (ORIF) using CAGE-DR implant by a single surgeon. Data including fracture type, angle of displacement, radiographic consolidation, grip strength, wrist range of motion (ROM), patient-rated wrist evaluation (PRWE), and Visual Analog Scale (VAS) pain scores were recorded at time of surgery and at standard follow-up. All 24 patients underwent uneventful ORIF. At first follow-up visit (9 days), all patients had full digital ROM (measured as 0 cm tip-to-palm distance). Two patients were lost to follow-up. Eighteen of the remaining 22 patients had sufficient radiographic follow-up and all 18 demonstrated healing. At latest follow-up (mean 9.7 months, range, 3-20), VAS pain scores averaged 0.6 (range, 0-8) and PRWE averaged 12.1 (range, 0-53.5). Grip strength of the operated hand averaged 58 lbs (range, 20-130). ROM included: wrist flexion 73° (50-95), wrist extension 78° (60-110), pronation 77° (60-90), supination 79° (60-90), ulnar deviation 31° (5-45), and radial deviation 17° (10-30). Three patients underwent screw removal to prevent tendon irritation. One patient underwent hardware removal due to prominence on imaging but was asymptomatic. There were otherwise no major complications, including complex regional pain syndrome, in the series to date. The CAGE-DR fracture fixation system is a promising alternative to established methods of distal radius internal fixation. This series has a low reported pain score starting immediately postoperatively and a low complication rate. This novel device is a promising option for internal fixation of displaced distal radius fractures with a low complication profile. This is a level IV, therapeutic study.
CAGE-DR植入物是一种经美国食品药品监督管理局批准的新型髓内骨折固定装置,用于治疗桡骨远端骨折。我们对22例患者进行了研究,并报告了使用该装置的治疗结果。
共有24例桡骨远端骨折患者(8例关节内AO C1/C2型;16例关节外AO A2/A3型)接受了由同一位外科医生使用CAGE-DR植入物进行的切开复位内固定术(ORIF)。记录了手术时和标准随访时的数据,包括骨折类型、移位角度、影像学骨愈合情况、握力、腕关节活动范围(ROM)、患者自评腕关节评估(PRWE)以及视觉模拟评分(VAS)疼痛评分。
所有24例患者均顺利接受了ORIF。在首次随访(9天)时,所有患者的手指活动范围均正常(指尖到手掌距离测量为0厘米)。2例患者失访。其余22例患者中有18例有足够的影像学随访资料,且所有18例均显示骨折愈合。在最近一次随访时(平均9.7个月,范围3 - 20个月),VAS疼痛评分平均为0.6(范围0 - 8),PRWE平均为12.1(范围0 - 53.5)。患侧手的握力平均为58磅(范围20 - 130)。活动范围包括:腕关节屈曲73°(50 - 95°),腕关节伸展78°(60 - 110°),旋前77°(60 - 90°),旋后79°(60 - 90°),尺偏31°(5 - 45°),桡偏17°(10 - 30°)。3例患者因防止肌腱刺激而取出螺钉。1例患者因影像学显示植入物突出但无症状而取出内固定装置。迄今为止,该系列中未出现包括复杂性区域疼痛综合征在内的其他重大并发症。
CAGE-DR骨折固定系统是桡骨远端内固定现有方法的一种有前景的替代方案。该系列报告的术后即刻疼痛评分较低,并发症发生率也较低。这种新型装置是治疗移位桡骨远端骨折的一种有前景的内固定选择,并发症较少。
这是一项IV级治疗性研究。