摘要
背景:在修复老年肱骨近端骨折时多采用常规手法复位或普通钢板固定修复,由于固定不稳固可出现骨折的畸形愈合。课题组以往研究发现,对老年肱骨近端骨折行切开复位肱骨近端常规锁定钢板内固定修复效果较好,但稳定性还需提高。临床实践表证明,锁定加压钢板以微创手术植入后稳定性良好,有利于骨折的愈合和功能的恢复。试验假设与常规锁定钢板相比,微创锁定加压钢板内固定有更好的稳定性和生物相容性,可更好地修复老年肱骨近端骨折和更有利于肩关节功能恢复。目的:观察微创锁定加压钢板内固定对老年肱骨近端骨折患者肩关节功能的改善作用。方法:研究为前瞻性、单中心、随机对照临床试验,将中国青海大学附属医院关节外科住院的老年肱骨近端骨折患者82例随机等分为2组,观察组行肩外侧小切口闭合复位+微创锁定加压钢板内固定,对照组行肩外侧小切口闭合复位+微创常规锁定钢板内固定,两组治疗后均随访6个月。方案中的主要结局为固定后6个月患者的Neer肩关节功能评分,以此评价肩关节功能恢复情况。次要结局为两组固定时间,术中出血量,固定后住院时间,骨折愈合时间,固定后0.5,1,3个月患者的Neer肩关节功能评分;固定后1,3 d,1,2周患者的目测类比评分,观察其与固定前评分相比患者疼痛缓解情况;固定后0.5,1,3,6个月患者的健康调查简表评分评估患者生活质量,固定后0.5,1,3,6个月患者骨折愈合质量的X射线检查,以评估固定后骨折愈合情况。试验经中国青海大学附属医院伦理委员会批准(审批号:QHY1005D)。参与者对试验内容和治疗过程均知情同意,并签署知情同意书。讨论:研究方案旨在分析微创锁定加压钢板内固定与常规锁定钢板相比,在改善老年肱骨近端骨折患者肩关节功能有效性的优势,为老年肱骨近端骨折内固定方法的选择提供
BACKGROUND：Manual reduction or traditional steel plate fixation is commonly used for repair of proximal humerus factures in older patients, because of poor stability, making these injuries prone to fracture malunion. While open reduction with steel plate fixation has a better outcome than closed reduction, the stability of internal fixation is stil less than satisfactory. Clinical studies have shown that minimal y invasive treatment with locking compression plates has presented good clinical results in terms of fixation stability, bone healing, and functional recovery. Therefore, we hypothesize that use of a locking compression plate wil provide better stability and that biocompatibility wil potentiate fracture healing and shoulder function recovery in older patients with proximal humerus fractures. OBJECTIVE：To observe the improvement of minimal y invasive treatment with locking compression plates in older patients with proximal humerus fractures. MEHTODS：This prospective, single-center, randomized control ed clinical trial wil be completed at the Department of Joint Surgery, Affiliated Hospital of Qinghai University in China. Eighty-two older patients with proximal humerus fractures wil be enrol ed and equivalently assigned to two groups. In the test group, patients wil undergo closed reduction via a lateral approach to the shoulder fol owed by locking compression plate fixation using a minimal y invasive technique, and those in the control group wil be subjected to closed reduction via a lateral approach to the shoulder fol owed by conventional steel plate fixation using a minimal y invasive technique. Al patients wil be fol owed up for 6 months. The primary outcome wil be recovery of shoulder function as indicated by clinical outcome scores according to the Neer classification system for proximal humeral fractures 6 months after surgery. The secondary outcomes wil include the operation time;intraoperative blood loss;postoperative hospital stay;fracture healing time;clinical outcome scores according to t
出处
《中国组织工程研究》
CAS
北大核心
2016年第44期6655-6660,共6页
Chinese Journal of Tissue Engineering Research
