中国组织工程研究

中国组织工程研究 ›› 2016, Vol. 20 ›› Issue (44): 6655-6660.doi: 10.3969/j.issn.2095-4344.2016.44.017

• 骨与关节临床实践 clinical practice of the bone and joint • 上一篇    下一篇

微创锁定加压钢板内固定改善老年肱骨近端骨折患者的肩关节功能：随机对照临床试验方案

吴 焘，张国秋   

  1. 青海大学附属医院关节外科，青海省西宁市 810001
  • 修回日期:2016-08-06 出版日期:2016-10-28 发布日期:2016-10-28
  • 通讯作者: 张国秋，教授，硕士生导师，青海大学附属医院关节外科，青海省西宁市 810001
  • 作者简介:吴焘，男，1985年生，山西省人，汉族，2010年青海大学毕业，硕士，主治医师，主要从关节置换及运动损伤的治疗研究。

Minimally invasive treatment of proximal humerus fractures with locking compression plate improves shoulder function in older patients: study protocol for a prospective randomized controlled trial

Wu Tao, Zhang Guo-qiu   

  1. Department of Joint Surgery, Affiliated Hospital of Qinghai University, Xining 810001, Qinghai Province, China
  • Revised:2016-08-06 Online:2016-10-28 Published:2016-10-28
  • Contact: Zhang Guo-qiu, Professor, Master’s supervisor, Department of Joint Surgery, Affiliated Hospital of Qinghai University, Xining 810001, Qinghai Province, China
  • About author:Wu Tao, Master, Attending physician, Department of Joint Surgery, Affiliated Hospital of Qinghai University, Xining 810001, Qinghai Province, China

PDF

328

摘要：

文章快速阅读：

 

 

文题释义：
肱骨骨折：可由暴力或间接暴力引起，直接暴力常由外侧击打肱骨干中份，致横形或粉碎形骨折。间接暴力常由于手部着地或肘部着地，力向上传导，加上身体倾倒所产生的剪式应力，导致中下1/3骨折，有时因投掷运动或“掰腕”也可导致中1/3骨折。
微创骨科内固定：是在X射线透视导引下经由小伤口植入特殊设计的骨板于骨膜外、皮肤和肌肉之下，横跨骨折处来固定骨折，主要包括微创骨折内固定系统、动力加压钢板和锁定加压钢板系统的置入内固定技术。
 
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客观数据。
试验注册信息：试验已于2016年5月19日在北美临床试验注册中心注册(NCT02784522)。

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

ORCID: 0000-0002-4538-7291(张国秋)

关键词: 骨科植入物, 人工假体, 临床试验, 肱骨近端骨折, 锁定加压钢板, 内固定, 稳定性, 肩外侧小切口, 闭合复位, 微创, 螺纹, 生物相容性, 组织工程

Abstract:

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 still less than satisfactory. Clinical studies have shown that minimally 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 will provide better stability and that biocompatibility will potentiate fracture healing and shoulder function recovery in older patients with proximal humerus fractures.

OBJECTIVE: To observe the improvement of minimally invasive treatment with locking compression plates in older patients with proximal humerus fractures.
MEHTODS: This prospective, single-center, randomized controlled clinical trial will be completed at the Department of Joint Surgery, Affiliated Hospital of Qinghai University in China. Eighty-two older patients with proximal humerus fractures will be enrolled and equivalently assigned to two groups. In the test group, patients will undergo closed reduction via a lateral approach to the shoulder followed by locking compression plate fixation using a minimally invasive technique, and those in the control group will be subjected to closed reduction via a lateral approach to the shoulder followed by conventional steel plate fixation using a minimally invasive technique. All patients will be followed up for 6 months. The primary outcome will 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 will include the operation time; intraoperative blood loss; postoperative hospital stay; fracture healing time; clinical outcome scores according to the Neer classification system 0.5, 1, and 3 months after surgery; visual analogue scale scores 1 and 3 days and 1 and 2 weeks after surgery to assess pain; scores of the Medical Outcomes Study 36-item short form health survey 0.5, 1, 3, and 6 months after surgery to assess quality of life; and X-ray examinations 0.5, 1, 3, and 6 months after surgery to assess fracture healing. The experiment was approved by the Ethics Committee of Affiliated Hospital of Qinghai University of China (approval No. QHY1005D). Participants were informed to the test content and treatment process, and signed informed consent.
DISCUSSION: This study protocol represents an attempt to objectively choose appropriate methods for internal fixation of proximal humerus fractures in older patients by comparing locking compression plate and conventional steel plate fixation to improve shoulder function.

TRIAL REGISTRATION: This trial was registered with the ClinicalTrials.gov identifier: NCT02784522; on 19 May 2016. 

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

Key words: Tissue Engineering, Humeral Fractures, Surgical Procedures, Minimally Invasive

中图分类号: