自带内锁髓内针的研制及其生物力学测试与初步临床应用
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摘要
目的：研制一种使用简易、固定可靠的新型四肢长管骨骨折内固定器械
——自带内锁髓内针，并对其生物力学性能进行测试，同时小组病例临
床应用，为临床安全应用提供依据。
方法：①采用国际标准的316L医用不锈钢根据生物学固定的原则自行
设计加工生产自带内锁髓内针。②对自带内锁髓内针进行生物力学测
试：新鲜成人股骨标本6副，在其中下段造成横断骨折并2cm的骨缺损，
分别用自带内锁髓内针、国产交锁髓内针、Ender氏针和梅花针内固定，
在MTS力学试验机上测量各种器械的抗旋转、抗短缩、和抗三点弯曲刚
度，并用SPSS统计软件对结果进行GLM-General Factorial ANOVA分
析。③用自带内锁髓内针治疗股骨骨折16例，用Klemn标准对疗效进
行评价。
结果：自带内锁髓内针的抗旋转、抗短缩刚度稍低于国产的交锁髓内针，
但无统计学意义（P＞0.05），抗三点弯曲刚度大于国产交锁髓内针
（P＜0.05）。其抗旋转、抗短缩和抗三点弯曲刚度则明显优于Ender氏
针、梅花针（P＜0.01）。临床应用16例，根据Klemn的评价标准，结果
优10例，良5例，可1例，优良率93.8％。
结论：自带内锁髓内针治疗长管骨骨折固定可靠，符合生物学固定的要
求，该器械结构合理、安全、简单、实用，具有一定的临床推广应用价
值。
Objective: A new kind of internal fixture, Self Bring Interlocking Nail
(SBIN), was developed, which was easy to be used and could develop firm
fixation for long bone fracture. In order to provide experiment and clinical
data for safe clinical practice, the biomechanic test and preliminary clinical
application were performed.
Methods: The SBIN was designed according to biological fixation principle
and made of 31 6L stainless steel. Six pairs of fresh adult moist cadaveric
femur specimens were used to manufacture fracture model of femur shaft in
low 1/3 part with 2cm bone defect and were divided into two groups. Group
1 was fixed using SBIN and KUntscher nail by turn. Group 2 was fixed by
homemade interlocking nail and Ender's nail. Biomechanic test was
performed on all specimens and the data were analysed by statistic SPSS
software (GLM-General Factorial ANO VA). 16 cases with femur shaft
fracture were treated by SBIN, the clinical results were divided into three
groups according to Klemn's criteria.
Results: The stiffness of SBIN in resisting to rotation and axial displacement
were close to that of the homemade interlocking nail. But there was no
significance between two nails (P>O.05) .The stiffness to resist bending of
SBIN was larger than that of homemade interlocking nail significantly
(P<0.0 1). The stiffness in resisting rotation, axial displacement and bending
were larger than that of the Kuntscher nail and Ender's nail significantly
(P<0.0 1). Excellent clinical results were obtained in 10 cases, good in 5 cases.
The excellent and good rate was 93.8%.
Conclusions: Being used in long bone fracture, the internal fixture of SBIN
was firm, dependable and accorded with the principle of biological fixation.
The instrument structure was in reason, safe, simple and practical .It could be
widely used in clinical practice.
——自带内锁髓内针，并对其生物力学性能进行测试，同时小组病例临
床应用，为临床安全应用提供依据。
方法：①采用国际标准的316L医用不锈钢根据生物学固定的原则自行
设计加工生产自带内锁髓内针。②对自带内锁髓内针进行生物力学测
试：新鲜成人股骨标本6副，在其中下段造成横断骨折并2cm的骨缺损，
分别用自带内锁髓内针、国产交锁髓内针、Ender氏针和梅花针内固定，
在MTS力学试验机上测量各种器械的抗旋转、抗短缩、和抗三点弯曲刚
度，并用SPSS统计软件对结果进行GLM-General Factorial ANOVA分
析。③用自带内锁髓内针治疗股骨骨折16例，用Klemn标准对疗效进
行评价。
结果：自带内锁髓内针的抗旋转、抗短缩刚度稍低于国产的交锁髓内针，
但无统计学意义（P＞0.05），抗三点弯曲刚度大于国产交锁髓内针
（P＜0.05）。其抗旋转、抗短缩和抗三点弯曲刚度则明显优于Ender氏
针、梅花针（P＜0.01）。临床应用16例，根据Klemn的评价标准，结果
优10例，良5例，可1例，优良率93.8％。
结论：自带内锁髓内针治疗长管骨骨折固定可靠，符合生物学固定的要
求，该器械结构合理、安全、简单、实用，具有一定的临床推广应用价
值。
Objective: A new kind of internal fixture, Self Bring Interlocking Nail
(SBIN), was developed, which was easy to be used and could develop firm
fixation for long bone fracture. In order to provide experiment and clinical
data for safe clinical practice, the biomechanic test and preliminary clinical
application were performed.
Methods: The SBIN was designed according to biological fixation principle
and made of 31 6L stainless steel. Six pairs of fresh adult moist cadaveric
femur specimens were used to manufacture fracture model of femur shaft in
low 1/3 part with 2cm bone defect and were divided into two groups. Group
1 was fixed using SBIN and KUntscher nail by turn. Group 2 was fixed by
homemade interlocking nail and Ender's nail. Biomechanic test was
performed on all specimens and the data were analysed by statistic SPSS
software (GLM-General Factorial ANO VA). 16 cases with femur shaft
fracture were treated by SBIN, the clinical results were divided into three
groups according to Klemn's criteria.
Results: The stiffness of SBIN in resisting to rotation and axial displacement
were close to that of the homemade interlocking nail. But there was no
significance between two nails (P>O.05) .The stiffness to resist bending of
SBIN was larger than that of homemade interlocking nail significantly
(P<0.0 1). The stiffness in resisting rotation, axial displacement and bending
were larger than that of the Kuntscher nail and Ender's nail significantly
(P<0.0 1). Excellent clinical results were obtained in 10 cases, good in 5 cases.
The excellent and good rate was 93.8%.
Conclusions: Being used in long bone fracture, the internal fixture of SBIN
was firm, dependable and accorded with the principle of biological fixation.
The instrument structure was in reason, safe, simple and practical .It could be
widely used in clinical practice.
引文
1.Hidakas, Grstilo RB. Refracture of bone of the forearm after plate removal. J Bone Joint Surg(Am),1984, 66:1241.
2.Uhthoff HK, Dubul FL. Bone structure changes in the dog under rigid internal fixation. Clin Orthop, 1971, 81:165.
3.Moyen BJ-L, Lahay PJ Jr, Weiberg EH, et al. Effects on intact femoral of dogs of the application and removal of metal plates: a metabolic and structural study comparing stiffer and more flexible plate. J Bone Joint Surg(Am), 1978, 60:940.
4．M.E.Muller,M.Allgower,R.Schneider,等著．荣国威，翟桂华，刘沂，等译．骨科内固定．第3版，北京：人民卫生出版社．1995；70．
5．Joseph Schalzker，姜春岩．AO/ASIF原则与方法的变迁．创伤骨科学报，1996，25(3)：205．
6.Schalzker J. Changes in the AO/ASIF principle and methods.Injury, 1995, 26:51.
7.Rush LV. Evolution of medullary fixation of fracture by the longitudinal pin. Clin Orthop, 1986,212:4-9.
8.Kuntscher G. Die Marknagelung Trummerbruches. Langenbecks Arch Klin Chir. 1968,322:1063.
9.Klemm K, Schellmann WD. The interlocking intramedullary nail. Int Congress Ser, 1974,291:1078.
10.Kempf, Grosse A, Abalo C. Locked intramedullary nailing: Its application to femoral and tibial axial rotational, lengthening, and shortening osteotomies. Clin Orthop, 1986,212:165.
11.Huckesfep RL. Rigid intramedullary fixation of femoral shaft fractures with compression. J Bone Joint Surg(Br),1972,54:204.
12.White GM, Healy WL, Brumback RJ. Treatment of fracture of the femoral shaft with the Brooker-Wills destal locking intramedullary nail. J Bone and Joint Surg(Am), 1986, 68:865.
13.Darder-Garcia A, Darder-Prats A, Gomar-Sancho F. Nonreamed flexible locked intramedullary nailing in tibial open fracture. Clin Orthop, 1998,350:97-104.
14.Christian Krettek, Bernd konemann, Theodore Miclau, et al. A mechanical distal aiming device for distal locking in femoral nails. Clin Orthop, 1999,364:267-275.
15．吴乃庆，陶松年，沈家维，等．鱼口交锁髓内针应用及扩孔影响皮质血供研究．中华骨科杂志，1993，13(3)：168．
16．吴岳嵩，徐卫东，陈舰，等．全锁髓内针的设计与临床应用．中华骨科杂志，1997，17(4)：248．
17．李健民，胥少汀，李铁防，等．组合式防旋髓内针的研制及临床应用．中华骨科杂志，1996，16(9)：547．
18．李健民，胥少汀，邹德威，等．髓内扩张自锁钉的结构特点及力学行为．中华骨科杂志，1998；18(12)：728．
19．张宏其，龙文荣，李康华．半圆形动态交锁髓内针的研制及其固定胫骨中下段骨折的临床应用．中华骨科杂志，1997，17(4)：220．
20.Lindsey-RW;Teal-P, Probe-RA, et al. Eearly experience with the gama interlocking nail for peritrochanteric fractures of the proximal femur. J-Trauma, 1991,31(12):1649.
21.Court-Brown-CM, Christle-J, McQueen-MM. Close intramedullary tibial nailing. Its use in closed and type I open fractures. J Bone Joint Surg(Br), 1990, 12(4):605-611.
22．过邦辅，编译．骨科生物力学基础．上海：上海远东出版社，1993：469．
23．罗先正，邱贵兴．髓内针内固定．北京：人民军医出版社，1998，12．
24．马安喜，于缓章，周康年，等．材料力学．第2版．北京：高等教育出版社，1987，370-385．
25.Whittle AP, Wester W, Rusell TA. Fatigue failure in small diameter tibial nail. Clin Orthop, 1995,315:119-128.
26.Haddad FS, Desai K, Sarkar JS, et al. The AO unreamed nail: friend or foe. Injury, 1996 , 27(4): 261-3.
27.Sargeant ID, Lovell M, Casserley H, et al. The AO unreamed tibial nail: a 14-month follow-up of the 1992 TT experience. Injury, 1994,25(7): 423-5.
28．刘长贵，张保中，郭艾，等．带锁髓内针治疗骨折并发症及防治．中华骨科杂志，1998，18(12)：725-727．
29.Giannoudis PV, Furlong AJ, Macdonald DA,et al. Reamed against unreamed nailing of the femoral diaphysis: a retrospective study of healing time. Injury, 1997, 28(1): 15-18.
30.Matter P. History of the AO and its global effect on operative fracture treatment. Clin Orthop, 1998,347:11-18.
31.Van-der-Elst-M, Bramer-JA, Klein-CP, et al. Biodegradable interlocking nails for fracture fixation. Clin Orthop, 1998 ,357: 192-204.
32.Mosheiff R, Safran O, Segal D,et al. The unreamed tibial nail in the treatment of distal metaphyseal fractures. Injury, 1999, 30(2): 83-90.
33.Tarr AR. The mechanics and biology of intramedullary fracture fixation. Clin Orthop, 1986,212:10.
34.Bankston AB, Keating EM, Saha S. The biomechanical evaluation of intramedullary nails in distal femoral shaft fractures. Clin Orthop, 1992, 276: 277-82.
35.Wainer RA, Wright PH, Gilbert JA, et al. Biomechanics of Ender rods, compression screw, and Zickel nail in the fixation of stable subtrochanteric femur osteotomies. J Orthop Trauma, 1990, 4(1): 58-63.
36．吴乃庆，宋李军，王道新，等．鱼口交锁髓内钉和其他三种交锁髓内钉的生物力学性能比较．中华骨科杂志，1997，17(4)：233-236．
37．罗先正，张薇．髓内钉的生物力学设计．中华骨科杂志，1997，17(5)：272-276．
38.Wolinsky PR, McCarty E, Shyr Y, et al. Reamed intramedullary nailing of the femur: 551 cases. J Trauma, 1999, 46(3): 392-399.
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43.Puno RM, Teynor JT, Nagano J, et al. Critical analysis of result
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44． Christie J, Court-Brown C, Kinninmonth AWG, et al. Intramedullary locking nail in the management of femoral shaft fracture. J Bone Joint Surg(Br), 1988,70:206．
45． Steawart MJ, Sisk TD , Wallace SL. Fractures of the distal third of femur. A comparison of methods of treatment. J Bone Joint Surg(Am), 1966, 48:784．
46． Connolly JF, Dehne E, Lafollette B. Close reduction and early cast-brace ambulation in the treatment of femoral fractures. Part II: results in one hundred and forty-three fractures. J Bone Joint Surg(Am), 1973,55:1581．
47． Healy WL, Brooker AF. Distal femoral fractures, Comparison of open and closed methods of treatment. Clin Orthop, 1983,174:166．
48． Wu CC, Shih CH, Ueng WN, et al. Treatment of segmental femoral shaft fractures. Clin Orthop, 1993,287: 224-230．
49． Rozbruch SR, Muller U, Gautier E , et al. The evolution of femoral shaft plating technique. Clin Orthop, 1998,354: 195-208．
50． Van-Niekerk-JL, Schoots-FJ. Femoral shaft fractures treated with plate fixation and interlocked nailing: a comparative retrospective study. Injury, 1992,23(4) : 219-222．
51． Abel EW, Sun-J. Mechanical evaluation of a new minimum-contact plate for internal fracture fixation. J Orthop Trauma, 1998, 12(6) : 382-386．
52． Perren SM . The concept of biological plating using the limited
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56.Giannoudis PV, Furlong AJ, Macdonald DA, et al. Reamed against unreamed nailing of the femoral diaphysis: a retrospective study of healing time. Injury, 1997, 28(1): 15-18.
57.Bucholz RW, Ross SE, Lawrence KL. Fatigue fracture of the interlocking nail in the treatment of fracture of the distal part of the femoral shaft. J Bone Joint Surg(Am), 1987,69:1391.
58.Karaoglu S, Baktir A, Tuncel M, et al. Closed Ender nailing of adolescent femoral shaft fractures. Injury, 1994,25(8):501-506.
59．吴岳嵩，徐伯诚，范肃临，等．矩形髓内钉的设计及临床应用．中华骨科杂志，1991，11(6)：405-409．
60.Walters J, Shepherd-Wilson-W, Lyons T, et al. Femoral shaft fractures treated by Ender nails using a trochanteric approach. J Bone Joint Surg(Br), 1990,72(1): 14-18.
61.Boxma H, Broekhuizen T, Patka P. Ramdomised controlled trial of single-dose antbotic prophylsxis in surgical treatment of close fracture:the Duch Trauma Trial. Lancet,1996,347:1133-1137.
62.Butler MS, Brumback RJ, Ellison TS, et al. Interlocking intramedullury nailing for ipsilateral of the femoral shaft and distal part of the femur. J Bone Joint Surg (Am),1991,73(10):1492-1502.
63.Benirschke SK, Melder I, Helney, et al. Closed interlocking nailing of femoral shaft fractures: assement of technical complication and functional outcomes by comparison of aprospective database with retrospective review. J Orthop Trauma, 1993,7(2):118-122.
64.Kershaw CJ, Cunningham JL, Kenwright J. Tibial external fixation, weight bearing and fracture movement. Clin Orthop, 1993,293:28-36.
65.Sarmiento A, Mckellop HA, Llinas A, et al. Effect of loading and fracture motions on diaphyseal tibial fracture. J Orthop Res, 1996,14:80-84.
66．林斌，郭延杰，郭林新，等．髓内针内固定失误原因分析．临床误诊误治杂志．1999，13(4)：306．
67．林斌，郭志民，郭延杰，等．一期髓内针内固定治疗多发伤的肢体骨折．中国矫形外科杂志，2000，7(1)：40．
68．林斌，陈建庭，金大地．交锁髓内针进展．中国矫形外科杂志，2000，7(6)：540．
69．张先龙，曹炳芳．微动对骨折愈合影响的研究进展．中华外科杂志，1998，36(5)：281-283．
2.Uhthoff HK, Dubul FL. Bone structure changes in the dog under rigid internal fixation. Clin Orthop, 1971, 81:165.
3.Moyen BJ-L, Lahay PJ Jr, Weiberg EH, et al. Effects on intact femoral of dogs of the application and removal of metal plates: a metabolic and structural study comparing stiffer and more flexible plate. J Bone Joint Surg(Am), 1978, 60:940.
4．M.E.Muller,M.Allgower,R.Schneider,等著．荣国威，翟桂华，刘沂，等译．骨科内固定．第3版，北京：人民卫生出版社．1995；70．
5．Joseph Schalzker，姜春岩．AO/ASIF原则与方法的变迁．创伤骨科学报，1996，25(3)：205．
6.Schalzker J. Changes in the AO/ASIF principle and methods.Injury, 1995, 26:51.
7.Rush LV. Evolution of medullary fixation of fracture by the longitudinal pin. Clin Orthop, 1986,212:4-9.
8.Kuntscher G. Die Marknagelung Trummerbruches. Langenbecks Arch Klin Chir. 1968,322:1063.
9.Klemm K, Schellmann WD. The interlocking intramedullary nail. Int Congress Ser, 1974,291:1078.
10.Kempf, Grosse A, Abalo C. Locked intramedullary nailing: Its application to femoral and tibial axial rotational, lengthening, and shortening osteotomies. Clin Orthop, 1986,212:165.
11.Huckesfep RL. Rigid intramedullary fixation of femoral shaft fractures with compression. J Bone Joint Surg(Br),1972,54:204.
12.White GM, Healy WL, Brumback RJ. Treatment of fracture of the femoral shaft with the Brooker-Wills destal locking intramedullary nail. J Bone and Joint Surg(Am), 1986, 68:865.
13.Darder-Garcia A, Darder-Prats A, Gomar-Sancho F. Nonreamed flexible locked intramedullary nailing in tibial open fracture. Clin Orthop, 1998,350:97-104.
14.Christian Krettek, Bernd konemann, Theodore Miclau, et al. A mechanical distal aiming device for distal locking in femoral nails. Clin Orthop, 1999,364:267-275.
15．吴乃庆，陶松年，沈家维，等．鱼口交锁髓内针应用及扩孔影响皮质血供研究．中华骨科杂志，1993，13(3)：168．
16．吴岳嵩，徐卫东，陈舰，等．全锁髓内针的设计与临床应用．中华骨科杂志，1997，17(4)：248．
17．李健民，胥少汀，李铁防，等．组合式防旋髓内针的研制及临床应用．中华骨科杂志，1996，16(9)：547．
18．李健民，胥少汀，邹德威，等．髓内扩张自锁钉的结构特点及力学行为．中华骨科杂志，1998；18(12)：728．
19．张宏其，龙文荣，李康华．半圆形动态交锁髓内针的研制及其固定胫骨中下段骨折的临床应用．中华骨科杂志，1997，17(4)：220．
20.Lindsey-RW;Teal-P, Probe-RA, et al. Eearly experience with the gama interlocking nail for peritrochanteric fractures of the proximal femur. J-Trauma, 1991,31(12):1649.
21.Court-Brown-CM, Christle-J, McQueen-MM. Close intramedullary tibial nailing. Its use in closed and type I open fractures. J Bone Joint Surg(Br), 1990, 12(4):605-611.
22．过邦辅，编译．骨科生物力学基础．上海：上海远东出版社，1993：469．
23．罗先正，邱贵兴．髓内针内固定．北京：人民军医出版社，1998，12．
24．马安喜，于缓章，周康年，等．材料力学．第2版．北京：高等教育出版社，1987，370-385．
25.Whittle AP, Wester W, Rusell TA. Fatigue failure in small diameter tibial nail. Clin Orthop, 1995,315:119-128.
26.Haddad FS, Desai K, Sarkar JS, et al. The AO unreamed nail: friend or foe. Injury, 1996 , 27(4): 261-3.
27.Sargeant ID, Lovell M, Casserley H, et al. The AO unreamed tibial nail: a 14-month follow-up of the 1992 TT experience. Injury, 1994,25(7): 423-5.
28．刘长贵，张保中，郭艾，等．带锁髓内针治疗骨折并发症及防治．中华骨科杂志，1998，18(12)：725-727．
29.Giannoudis PV, Furlong AJ, Macdonald DA,et al. Reamed against unreamed nailing of the femoral diaphysis: a retrospective study of healing time. Injury, 1997, 28(1): 15-18.
30.Matter P. History of the AO and its global effect on operative fracture treatment. Clin Orthop, 1998,347:11-18.
31.Van-der-Elst-M, Bramer-JA, Klein-CP, et al. Biodegradable interlocking nails for fracture fixation. Clin Orthop, 1998 ,357: 192-204.
32.Mosheiff R, Safran O, Segal D,et al. The unreamed tibial nail in the treatment of distal metaphyseal fractures. Injury, 1999, 30(2): 83-90.
33.Tarr AR. The mechanics and biology of intramedullary fracture fixation. Clin Orthop, 1986,212:10.
34.Bankston AB, Keating EM, Saha S. The biomechanical evaluation of intramedullary nails in distal femoral shaft fractures. Clin Orthop, 1992, 276: 277-82.
35.Wainer RA, Wright PH, Gilbert JA, et al. Biomechanics of Ender rods, compression screw, and Zickel nail in the fixation of stable subtrochanteric femur osteotomies. J Orthop Trauma, 1990, 4(1): 58-63.
36．吴乃庆，宋李军，王道新，等．鱼口交锁髓内钉和其他三种交锁髓内钉的生物力学性能比较．中华骨科杂志，1997，17(4)：233-236．
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