Norian SRS cement compared with conventional fixation in distal radial fractures - A randomized study
Norian SRS cement compared with conventional fixation in distal radial fractures - A randomized study
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DOI：
10.2106/00004623-200311000-00010
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发表时间：
2003-11-01
影响因子：
5.3
通讯作者：
Constanz, B
中科院分区：
文献类型：
--
作者：
Cassidy, C;Jupiter, JB;Constanz, B
背景资料：进行了一项前瞻性、随机、多中心研究，以评价使用和不使用Norian SRS（Skeleton Repair System）骨水泥进行闭合复位和固定治疗桡骨远端骨折的效果。Norian SRS是一种磷酸钙骨水泥，可注射，硬化原位，并通过结晶反应形成dahlite，碳酸磷灰石相当于bone mineral.Methods：共323例桡骨远端骨折患者随机治疗或不Norian SRS水泥。分层因素包括骨折类型（关节内或关节外）、手部优势、骨密度和外科医生首选的常规治疗（石膏或外固定器）。接受Norian SRS的受试者接受闭合复位，然后注射骨水泥perdendant或通过有限开放入路。腕关节活动，术后两周开始，鼓励。未接受Norian SRS注射的对照组受试者接受闭合复位并应用石膏或外固定器6至8周。两组在特定情况下均使用了辅助克氏针。在1、2、4、6 - 8周和3、6、12个月时对患者进行临床和影像学随访。患者使用视觉模拟量表评定疼痛和手的功能。使用简明健康状况调查表（SF-36）评估生活质量。结果：术后6 ~ 8周，Norian SRS组患者的握力、腕关节活动度、手指活动度、手的使用、社会和情感功能均优于对照组（P < 0.05），肿胀程度低于对照组（P < 0.05）。到3个月时，这些差异已正常化，但手指运动除外，Norian SRS治疗组的手指运动仍显著更好（p = 0.015）。一年后，未检测到临床差异。放射学上，Norian SRS治疗组uInar方差的平均变化（+2.0 mm）大于对照组（+1.4 mm）（p < 0.02）。在并发症总数方面没有差异，包括复位丢失。然而，对照组的感染率（16.7%）显著高于Norian SRS组（2.5%）（p < 0.001），且感染总是与外固定器针或克氏针有关。确定了4例关节内骨水泥外渗的患者;在24个月时未观察到后遗症。在112例（70%）SRS治疗患者的骨外位置观察到骨水泥;该亚组的复位丢失率最高（37%）。骨外材料消失在83的112个patients.Conclusions：我们的研究结果表明，固定的桡骨远端骨折与Norian SRS水泥可以加速康复。建议采用有限的开放入路和克氏针辅助固定。对于复杂的关节骨折，需要额外或替代固定。证据等级：治疗研究，I-1a级（随机对照试验[显著差异]）。证据等级的完整描述见作者说明。
Background: A prospective, randomized multicenter study was conducted to evaluate closed reduction and immobilization with and without Norian SRS (Skeletal Repair System) cement in the management of distal radial fractures. Norian SRS is a calcium-phosphate bone cement that is injectable, hardens in situ, and cures by a crystallization reaction to form dahllite, a carbonated apatite equivalent to bone mineral.Methods: A total of 323 patients with a distal radial fracture were randomized to treatment with or without Norian SRS cement. Stratification factors included fracture type (intra-articular or extra-articular), hand dominance, bone density, and the surgeon's preferred conventional treatment (cast or external fixator). The subjects receiving Norian SRS underwent a closed reduction followed by injection of the cement percutaneously or through a limited open approach. Wrist motion, beginning two weeks postoperatively, was encouraged. Control subjects, who had not received a Norian SRS injection, underwent closed reduction and application of a cast or external fixator for six to eight weeks. Supplemental Kirschner wires were used in specific instances in both groups. Patients were followed clinically and radiographically at one, two, four, and between six and eight weeks and at three, six, and twelve months. Patients rated pain and the function of the hand with use of a visual analog scale. Quality of life was assessed with use of the Short Form-36 (SF-36) health status questionnaire. Complications were recorded.Results: Significant clinical differences were seen at six to eight weeks postoperatively, with better grip strength, wrist range of motion, digital motion, use of the hand, and social and emotional function, and less swelling in the patients treated with Norian SRS than in the control group (p < 0.05). By three months, these differences had normalized except for digital motion, which remained significantly better in the group treated with Norian SRS (p = 0.015). At one year, no clinical differences were detected. Radiographically, the average change in uInar variance was greater in the patients treated with Norian SRS (+2.0 mm) than in the control group (+1.4 mm) (p < 0.02). No differences were seen in the total number of complications, including loss of reduction. The infection rate, however, was significantly higher (p < 0.001) in the control group (16.7%) than in the group treated with Norian SRS (2.5%) and the infections were always related to external fixator pins or Kirschner wires. Four patients with intra-articular extravasation of cement were identified; no sequelae were observed at twenty-four months. Cement was seen in extraosseous locations in 112 (70%) of the SRS-treated patients; loss of reduction was highest in this subgroup (37%). The extraosseous material had disappeared in eighty-three of the 112 patients by twelve months.Conclusions: Our results indicate that fixation of a distal radial fracture with Norian SRS cement may allow for accelerated rehabilitation. A limited open approach and supplemental fixation with Kirschner wires are recommended. Additional or alternate fixation is necessary for complex articular fractures.Level of Evidence: Therapeutic study, Level I-1a (randomized controlled trial [significant difference]). See Instructions to Authors for a complete description of levels of evidence.