Pectoralis Major Pedicle Bone Graft For 4-Part Proximal Humerus Fractures
2021年7月30日 更新者：Bulent KARSLIOGLU、Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
The investigators tried to evaluate the results of our patients who underwent plate osteosynthesis with vascularized pectoralis major graft for the treatment of 4-part proximal humerus fractures.
研究概览
地位
完全的
详细说明
The risk of avascular necrosis, nonunion, or malunion is high in 4-part fractures which is the most serious form of proximal humerus fracture.Bone impaction grafts are an important treatment option when osteosynthesis with LCP plate is desired especially for osteoporotic patients.
Fibular strut grafts (FSGs) and autologous iliac bone impaction grafts (AIBIGs), which are frequently used to provide mechanical support, may have the risk of nonunion in osteoporotic bone whose vascular support is weakened due to fracture.
Bone pedicled pectoralis major grafts may prevent varus collapse, nonunion and avascular necrosis.
研究类型
介入性
注册 (实际的)
17
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
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Istanbul、火鸡、34040
- SBU Prof. Cemil Tascioglu City Hospital
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
50年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- patients aged 50-75 years with closed Neer type 4 proximal humerus fractures
Exclusion Criteria:
- Patients under 50 and over 75 years of age,
- Patients with pathological fractures,
- Patients with neurological deficits such as brachial plexus injury
- Patients with previous shoulder surgery
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：Patients with closed Neer type 4 proximal humerus fractures
patients aged 50-75 years with closed Neer type 4 proximal humerus fractures
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It is aimed to restore the integrity of the medial cortex with the bone pedicle from the insertion region of the pectoralis major muscle in middle-aged patients with Neer type 4 proximal humerus fractures.
Researchers aim to reduce the risk of avascular necrosis with a vascular living bone tissue, as well as providing mechanical support with this method.
The investigators aim to reduce the risk of avascular necrosis with a vascular living bone tissue, as well as providing mechanical support with this method.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Patients were evaluated in terms of functional shoulder results and radiographic union
大体时间：2 years
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Constant and American shoulder and elbow surgeons scores were used for functional assesment
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2 years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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- Neer CS 2nd. Displaced proximal humeral fractures. I. Classification and evaluation. J Bone Joint Surg Am. 1970 Sep;52(6):1077-89. No abstract available.
- Fialka C, Stampfl P, Arbes S, Reuter P, Oberleitner G, Vecsei V. Primary hemiarthroplasty in four-part fractures of the proximal humerus: randomized trial of two different implant systems. J Shoulder Elbow Surg. 2008 Mar-Apr;17(2):210-5. doi: 10.1016/j.jse.2007.07.002. Epub 2007 Oct 10.
- Kim SH, Lee YH, Chung SW, Shin SH, Jang WY, Gong HS, Baek GH. Outcomes for four-part proximal humerus fractures treated with a locking compression plate and an autologous iliac bone impaction graft. Injury. 2012 Oct;43(10):1724-31. doi: 10.1016/j.injury.2012.06.029. Epub 2012 Jul 20.
- Konrad G, Bayer J, Hepp P, Voigt C, Oestern H, Kaab M, Luo C, Plecko M, Wendt K, Kostler W, Sudkamp N. Open reduction and internal fixation of proximal humeral fractures with use of the locking proximal humerus plate. Surgical technique. J Bone Joint Surg Am. 2010 Mar;92 Suppl 1 Pt 1:85-95. doi: 10.2106/JBJS.I.01462.
- Clavert P, Adam P, Bevort A, Bonnomet F, Kempf JF. Pitfalls and complications with locking plate for proximal humerus fracture. J Shoulder Elbow Surg. 2010 Jun;19(4):489-94. doi: 10.1016/j.jse.2009.09.005. Epub 2009 Dec 7.
- Gallo RA, Sciulli R, Daffner RH, Altman DT, Altman GT. Defining the relationship between rotator cuff injury and proximal humerus fractures. Clin Orthop Relat Res. 2007 May;458:70-7. doi: 10.1097/BLO.0b013e31803bb400.
- Choo A, Sobol G, Maltenfort M, Getz C, Abboud J. Prevalence of rotator cuff tears in operative proximal humerus fractures. Orthopedics. 2014 Nov;37(11):e968-74. doi: 10.3928/01477447-20141023-52.
- Kim SH, Szabo RM, Marder RA. Epidemiology of humerus fractures in the United States: nationwide emergency department sample, 2008. Arthritis Care Res (Hoboken). 2012 Mar;64(3):407-14. doi: 10.1002/acr.21563.
- Adeyemo A, Bertha N, Perry KJ, Updegrove G. Implant Selection for Proximal Humerus Fractures. Orthop Clin North Am. 2021 Apr;52(2):167-175. doi: 10.1016/j.ocl.2020.12.008. Epub 2021 Feb 10.
- Hardeman F, Bollars P, Donnelly M, Bellemans J, Nijs S. Predictive factors for functional outcome and failure in angular stable osteosynthesis of the proximal humerus. Injury. 2012 Feb;43(2):153-8. doi: 10.1016/j.injury.2011.04.003. Epub 2011 May 12.
- Laflamme GY, Moisan P, Chapleau J, Goulet J, Leduc S, Benoit B, Rouleau DM. Novel Technical Factors Affecting Proximal Humerus Fixation Stability. J Orthop Trauma. 2021 May 1;35(5):259-264. doi: 10.1097/BOT.0000000000001984.
- Voigt C, Kreienborg S, Megatli O, Schulz AP, Lill H, Hurschler C. How does a varus deformity of the humeral head affect elevation forces and shoulder function? A biomechanical study with human shoulder specimens. J Orthop Trauma. 2011 Jul;25(7):399-405. doi: 10.1097/BOT.0b013e31820beb80.
- Krappinger D, Bizzotto N, Riedmann S, Kammerlander C, Hengg C, Kralinger FS. Predicting failure after surgical fixation of proximal humerus fractures. Injury. 2011 Nov;42(11):1283-8. doi: 10.1016/j.injury.2011.01.017. Epub 2011 Feb 9.
- Katthagen JC, Schwarze M, Meyer-Kobbe J, Voigt C, Hurschler C, Lill H. Biomechanical effects of calcar screws and bone block augmentation on medial support in locked plating of proximal humeral fractures. Clin Biomech (Bristol, Avon). 2014 Aug;29(7):735-41. doi: 10.1016/j.clinbiomech.2014.06.008. Epub 2014 Jun 19.
- Kim YK, Kang SW, Jung KH, Oh YK. The potential of locking plate with intramedullary fibular allograft to manage proximal humeral fracture with an unstable medial column. Arch Orthop Trauma Surg. 2022 Jan;142(1):91-97. doi: 10.1007/s00402-020-03604-2. Epub 2020 Sep 18.
- Gardner MJ, Weil Y, Barker JU, Kelly BT, Helfet DL, Lorich DG. The importance of medial support in locked plating of proximal humerus fractures. J Orthop Trauma. 2007 Mar;21(3):185-91. doi: 10.1097/BOT.0b013e3180333094.
- McMillan TE, Johnstone AJ. Primary screw perforation or subsequent screw cut-out following proximal humerus fracture fixation using locking plates: a review of causative factors and proposed solutions. Int Orthop. 2018 Aug;42(8):1935-1942. doi: 10.1007/s00264-017-3652-6. Epub 2017 Oct 7.
- Schnetzke M, Bockmeyer J, Loew M, Studier-Fischer S, Grutzner PA, Guehring T. Rate of avascular necrosis after fracture dislocations of the proximal humerus: Timing of surgery. Obere Extrem. 2018;13(4):273-278. doi: 10.1007/s11678-018-0452-6. Epub 2018 Mar 7.
- Neviaser AS, Hettrich CM, Dines JS, Lorich DG. Rate of avascular necrosis following proximal humerus fractures treated with a lateral locking plate and endosteal implant. Arch Orthop Trauma Surg. 2011 Dec;131(12):1617-22. doi: 10.1007/s00402-011-1366-6. Epub 2011 Aug 4.
- Peng C-H, Wu W-T, Yu T-C, Chen L-C, Hsu S-H, Kwong S-T, et al. Surgical treatment for proximal humeral fracture in elderly patients with emphasis on the use of intramedullary strut allografts. Tzu Chi Medical Journal 2012;24:131-5.
- Chen H, Ji X, Zhang Q, Liang X, Tang P. Clinical outcomes of allograft with locking compression plates for elderly four-part proximal humerus fractures. J Orthop Surg Res. 2015 Jul 22;10:114. doi: 10.1186/s13018-015-0258-9.
- Reilly P, Macleod I, Macfarlane R, Windley J, Emery RJ. Dead men and radiologists don't lie: a review of cadaveric and radiological studies of rotator cuff tear prevalence. Ann R Coll Surg Engl. 2006 Mar;88(2):116-21. doi: 10.1308/003588406X94968.
- Fung L, Wong B, Ravichandiran K, Agur A, Rindlisbacher T, Elmaraghy A. Three-dimensional study of pectoralis major muscle and tendon architecture. Clin Anat. 2009 May;22(4):500-8. doi: 10.1002/ca.20784.
- Bois AJ, Lo IKY. Surgical anatomy of the pectoralis major tendon insertion revisited: relationship to nearby structures and the pectoral eminence for defining the anatomic footprint. JSES Int. 2020 May 7;4(2):324-332. doi: 10.1016/j.jseint.2020.02.010. eCollection 2020 Jun.
- Meier JK, Spoerl S, Spanier G, Wunschel M, Gottsauner MJ, Schuderer J, Reichert TE, Ettl T. Alternatives to free flap surgery for maxillofacial reconstruction: focus on the submental island flap and the pectoralis major myocutaneous flap. BMC Oral Health. 2021 Apr 19;21(1):198. doi: 10.1186/s12903-021-01563-7.
- Wyckman A, Abdelrahman I, Steinvall I, Zdolsek J, Granfeldt H, Sjoberg F, Nettelblad H, Elmasry M. Reconstruction of sternal defects after sternotomy with postoperative osteomyelitis, using a unilateral pectoralis major advancement muscle flap. Sci Rep. 2020 May 20;10(1):8380. doi: 10.1038/s41598-020-65398-y.
- Aydin N, Tutuncu MN, Sekizkardes M. Pectoralis major tendon transfer for subscapularis deficiency following multiple failed instability surgeries: A case report. Acta Orthop Traumatol Turc. 2020 Nov;54(6):651-654. doi: 10.5152/j.aott.2020.19174.
- Resch H, Povacz P, Maurer H, Koller H, Tauber M. Pectoralis major inverse plasty for functional reconstruction in patients with anterolateral deltoid deficiency. J Bone Joint Surg Br. 2008 Jun;90(6):757-63. doi: 10.1302/0301-620X.90B6.19804.
- Freeman JL, Walker EP, Wilson JS, Shaw HJ. The vascular anatomy of the pectoralis major myocutaneous flap. Br J Plast Surg. 1981 Jan;34(1):3-10. doi: 10.1016/0007-1226(81)90086-2.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年1月1日
初级完成 (实际的)
2020年1月30日
研究完成 (实际的)
2020年2月1日
研究注册日期
首次提交
2021年7月30日
首先提交符合 QC 标准的
2021年7月30日
首次发布 (实际的)
2021年8月9日
研究记录更新
最后更新发布 (实际的)
2021年8月9日
上次提交的符合 QC 标准的更新
2021年7月30日
最后验证
2021年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.