采用Gemini MKⅡ旋转活动平台假体行全膝关节置换术的临床疗效
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摘要
目的试图阐明采用Gemini MKII（Link,Germany）旋转活动平台假体行全膝关节置换术的早、中期疗效。
方法2004年1月～2009年6月，按纳入和排除标准且获得随访的患者共143例（158膝），其中15例行双侧一期TKA，平均年龄63.1±10.7岁，平均体重指数（BMI）26.8±2.4。术前诊断：退变性骨关节炎109例（121膝），类风湿性关节炎21例（24膝），创伤后关节炎11例（11膝），性病性Charcot’s病1例（1膝），血友病性关节炎1例（1膝）。假体均采用骨水泥固定，无1例行髌骨置换手术。男57例(66膝)，其中9例行双侧一期TKA，平均年龄65.2±8.5岁，平均体重指数（BMI）25.4±1.3，术前诊断：退变性骨性关节炎44例（51膝），类风湿性关节炎5例（7膝），创伤性关节炎6例（6膝），性病性Charcot’s病1例（1膝），血友病性关节炎1例（1膝）；女86例(92膝)，其中6例行双侧一期TKA，平均年龄61.5±13.5岁，平均体重指数27.6±4.1，术前诊断：退变性骨性关节炎65例（69膝），类风湿性关节炎16例（18膝），创伤性关节炎5例（5膝）。
结果所有病例获平均随访4.6±1.8年，其中获至少5年随访者76例。本组无1例感染、股骨髁骨折或神经、血管损伤等并发症。除双侧TKA外，单侧TKA的平均手术时间60min（范围：45～90min），平均术后血红蛋白（Hb）下降值为25±5g/L，其中有108例（84.4%）因术后Hb仍维持在100g/L以上无需输血。1.临床疗效：术后膝关节评分和功能评分均较术前有显著的改善（P<0.01）,分别由术前的46.7±7.2分和47.8±8.8分提高至术后的92.8±4.5分和90.4±6.5分。活动度（ROM）由术前86.4±11.8°提高至术后的114.7±8.1°，均有显著性差异（P<0.01）。疼痛评分和Fellar髌骨评分分别由术前的12.4±7.5分和18.2±4.5分提高至术后的45.3±4.6分和27.6±3.2分（P<0.01）。男、女两组在术前和术后膝关节评分上有差异（P=0.04，P=0.02），在术后功能评分、活动度、疼痛评分和髌骨评分上均无差异(P=0.94,P=0.70,P=0.44和P=0.83)。2.影像学评分：术后正位片上测量的股骨角、胫骨角、和侧位片上测量的胫骨平台后倾角、股骨屈曲角分别为96.3±1.1°，89.7±1.5°，85.2±1.7°以及1.4±0.5°。胫骨平台在冠状位和矢状位上的覆盖率分别为96.4±3.1%和98.6±1.4%。男女组的影像学评分无统计学差异（P=0.27,P=0.96,P=0.14，P=0.82，P=0.23和P=0.43）。术后及随访末期的X线片均未显示有任何假体周围的骨溶解、X线透亮线或假体松动迹象。至今无1例因内衬脱出或旋出，以及因骨溶解和假体松动需行翻修。
结论采用Gemini MKII（Link,Germany）旋转活动平台假体行全膝关节置换术，可有效缓解疼痛，恢复关节功能，手术操作简单，术后恢复快，并发症少，在男性患者和女性患者中均可获得满意的早中期疗效，但远期疗效仍有待证实。
Objective: To clarify the early and mid-term clinical result of the TKA with Gemini MKII knee prostheis（Link,Germany）.
Methods:From January2004to June2009,143patients(158knees) including57males and86females at mean63.1±10.7years were treated with total knee arthroplasty by usingGemini MKⅡ system. Body mass index (BMI) averaged26.8±2.4.128Unilateral cases,15bilateral cases. Preoperative diagnosis:109(121knees) Degenerative osteoarthritis,21(24knees) Rheumatoid arthritis,11(11knees) Post-traumatic arthritis,1(1knee)Charcot’s disease,1(1knee) Hemophilic arthritis.Prosthesis were fixed with bone cement.No one with patellar replacement. In male cases, the mean age is65.2±8.5years with theBMI25.4±1.3.48Unilateral cases,9bilateral cases.Preoperative diagnosis:44(51knees)Degenerative osteoarthritis,5(7knees) Rheumatoid arthritis,6(6knees) Post-traumaticarthritis,1(1knee) Charcot’s disease,1(1knee) Hemophilic arthritis. In female cases, themean age is61.5±13.5years with the BMI27.6±4.1.80Unilateral cases,6bilateral cases.Preoperative diagnosis:65(69knees) Degenerative osteoarthritis,16(18knees)Rheumatoid arthritis,5(5knees) Post-traumatic arthritis.
Results: No one case of infection, femoral condyle fracture or nerve, vascular damage andother complications. Except unilateral TKA, the average operation time was60minutes(range:45-90minutes), and the average postoperative hemoglobin(Hb) decreased2.5±0.5g/L.108patients (84.4%) without blood transfusion, because of postoperative Hbremained in100g/L or more. The mean follow-up was4.6±1.8years, and76patients haveat least5years follow-up.1. Clinical Evaluation: The preoperative mean knee score, meanROM（range of motion）and mean function score respectively improved from46.7±7.2points to92.8±4.5points, from86.4±11.8°to114.7±8.1°and from47.8±8.8points to 90.4±6.5points at the most recent follow-up. The preoperative mean pain score and Fellarscore respectively improved from12.4±7.5points to45.3±4.6points and from18.2±4.5points to27.6±3.2points at the most recent follow-up.The postoperative knee score,function score, ROM, pain score and Fellar score were significant higher thanpreoperative(P<0.01). Comparing male with female, there were differences in thepreoperative and postoperative knee score(P=0.04,P=0.02), and the postoperative functionscore, ROM, pain score and Fellar score were no significant difference (P=0.94,P=0.96,P=0.44and P=0.83).2. Radiographic Evaluation: The angles were measured on theanteroposterior film and lateral radiography. Mean femoral angle96.3±1.1°, mean tibialangle89.7±1.5°, mean posterior slope angle of tibial plateau85.2±1.7°and mean femoralflexion angle1.4±0.5°. Comparing male with female, the femoral angle, tibial angle,posterior slope angle of tibial and femoral flexion angle were no significant difference(P=0.27,P=0.96,P=0.14and P=0.82). Coverage of the tibial plateau in the coronal andsagittal, respectively,96.4±3.1%and98.6±1.4%. NO significant difference between maleand female(P=0.23and P=0.43). No evidence of periprosthetic osteolysis,translucent linesand loosening on the postoperative X-ray film. No revision surgery for lining prolapse orspin out, osteolysis and prosthesis loosening.
Conclusions: Performing TKA with Gemini MKⅡmobile rotating-platform prosthesis canalleviate pain and restore joint function effectively, simple operation, rapid postoperativerecovery, fewer complications. The early and midterm results of Gemini MKⅡmobilerotating-platform prosthesis was satisfactory both in male and female,but the long-termresults remains to be confirmed.
方法2004年1月～2009年6月，按纳入和排除标准且获得随访的患者共143例（158膝），其中15例行双侧一期TKA，平均年龄63.1±10.7岁，平均体重指数（BMI）26.8±2.4。术前诊断：退变性骨关节炎109例（121膝），类风湿性关节炎21例（24膝），创伤后关节炎11例（11膝），性病性Charcot’s病1例（1膝），血友病性关节炎1例（1膝）。假体均采用骨水泥固定，无1例行髌骨置换手术。男57例(66膝)，其中9例行双侧一期TKA，平均年龄65.2±8.5岁，平均体重指数（BMI）25.4±1.3，术前诊断：退变性骨性关节炎44例（51膝），类风湿性关节炎5例（7膝），创伤性关节炎6例（6膝），性病性Charcot’s病1例（1膝），血友病性关节炎1例（1膝）；女86例(92膝)，其中6例行双侧一期TKA，平均年龄61.5±13.5岁，平均体重指数27.6±4.1，术前诊断：退变性骨性关节炎65例（69膝），类风湿性关节炎16例（18膝），创伤性关节炎5例（5膝）。
结果所有病例获平均随访4.6±1.8年，其中获至少5年随访者76例。本组无1例感染、股骨髁骨折或神经、血管损伤等并发症。除双侧TKA外，单侧TKA的平均手术时间60min（范围：45～90min），平均术后血红蛋白（Hb）下降值为25±5g/L，其中有108例（84.4%）因术后Hb仍维持在100g/L以上无需输血。1.临床疗效：术后膝关节评分和功能评分均较术前有显著的改善（P<0.01）,分别由术前的46.7±7.2分和47.8±8.8分提高至术后的92.8±4.5分和90.4±6.5分。活动度（ROM）由术前86.4±11.8°提高至术后的114.7±8.1°，均有显著性差异（P<0.01）。疼痛评分和Fellar髌骨评分分别由术前的12.4±7.5分和18.2±4.5分提高至术后的45.3±4.6分和27.6±3.2分（P<0.01）。男、女两组在术前和术后膝关节评分上有差异（P=0.04，P=0.02），在术后功能评分、活动度、疼痛评分和髌骨评分上均无差异(P=0.94,P=0.70,P=0.44和P=0.83)。2.影像学评分：术后正位片上测量的股骨角、胫骨角、和侧位片上测量的胫骨平台后倾角、股骨屈曲角分别为96.3±1.1°，89.7±1.5°，85.2±1.7°以及1.4±0.5°。胫骨平台在冠状位和矢状位上的覆盖率分别为96.4±3.1%和98.6±1.4%。男女组的影像学评分无统计学差异（P=0.27,P=0.96,P=0.14，P=0.82，P=0.23和P=0.43）。术后及随访末期的X线片均未显示有任何假体周围的骨溶解、X线透亮线或假体松动迹象。至今无1例因内衬脱出或旋出，以及因骨溶解和假体松动需行翻修。
结论采用Gemini MKII（Link,Germany）旋转活动平台假体行全膝关节置换术，可有效缓解疼痛，恢复关节功能，手术操作简单，术后恢复快，并发症少，在男性患者和女性患者中均可获得满意的早中期疗效，但远期疗效仍有待证实。
Objective: To clarify the early and mid-term clinical result of the TKA with Gemini MKII knee prostheis（Link,Germany）.
Methods:From January2004to June2009,143patients(158knees) including57males and86females at mean63.1±10.7years were treated with total knee arthroplasty by usingGemini MKⅡ system. Body mass index (BMI) averaged26.8±2.4.128Unilateral cases,15bilateral cases. Preoperative diagnosis:109(121knees) Degenerative osteoarthritis,21(24knees) Rheumatoid arthritis,11(11knees) Post-traumatic arthritis,1(1knee)Charcot’s disease,1(1knee) Hemophilic arthritis.Prosthesis were fixed with bone cement.No one with patellar replacement. In male cases, the mean age is65.2±8.5years with theBMI25.4±1.3.48Unilateral cases,9bilateral cases.Preoperative diagnosis:44(51knees)Degenerative osteoarthritis,5(7knees) Rheumatoid arthritis,6(6knees) Post-traumaticarthritis,1(1knee) Charcot’s disease,1(1knee) Hemophilic arthritis. In female cases, themean age is61.5±13.5years with the BMI27.6±4.1.80Unilateral cases,6bilateral cases.Preoperative diagnosis:65(69knees) Degenerative osteoarthritis,16(18knees)Rheumatoid arthritis,5(5knees) Post-traumatic arthritis.
Results: No one case of infection, femoral condyle fracture or nerve, vascular damage andother complications. Except unilateral TKA, the average operation time was60minutes(range:45-90minutes), and the average postoperative hemoglobin(Hb) decreased2.5±0.5g/L.108patients (84.4%) without blood transfusion, because of postoperative Hbremained in100g/L or more. The mean follow-up was4.6±1.8years, and76patients haveat least5years follow-up.1. Clinical Evaluation: The preoperative mean knee score, meanROM（range of motion）and mean function score respectively improved from46.7±7.2points to92.8±4.5points, from86.4±11.8°to114.7±8.1°and from47.8±8.8points to 90.4±6.5points at the most recent follow-up. The preoperative mean pain score and Fellarscore respectively improved from12.4±7.5points to45.3±4.6points and from18.2±4.5points to27.6±3.2points at the most recent follow-up.The postoperative knee score,function score, ROM, pain score and Fellar score were significant higher thanpreoperative(P<0.01). Comparing male with female, there were differences in thepreoperative and postoperative knee score(P=0.04,P=0.02), and the postoperative functionscore, ROM, pain score and Fellar score were no significant difference (P=0.94,P=0.96,P=0.44and P=0.83).2. Radiographic Evaluation: The angles were measured on theanteroposterior film and lateral radiography. Mean femoral angle96.3±1.1°, mean tibialangle89.7±1.5°, mean posterior slope angle of tibial plateau85.2±1.7°and mean femoralflexion angle1.4±0.5°. Comparing male with female, the femoral angle, tibial angle,posterior slope angle of tibial and femoral flexion angle were no significant difference(P=0.27,P=0.96,P=0.14and P=0.82). Coverage of the tibial plateau in the coronal andsagittal, respectively,96.4±3.1%and98.6±1.4%. NO significant difference between maleand female(P=0.23and P=0.43). No evidence of periprosthetic osteolysis,translucent linesand loosening on the postoperative X-ray film. No revision surgery for lining prolapse orspin out, osteolysis and prosthesis loosening.
Conclusions: Performing TKA with Gemini MKⅡmobile rotating-platform prosthesis canalleviate pain and restore joint function effectively, simple operation, rapid postoperativerecovery, fewer complications. The early and midterm results of Gemini MKⅡmobilerotating-platform prosthesis was satisfactory both in male and female,but the long-termresults remains to be confirmed.
引文
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56.Robertsson0,Dunbar M，Pehrsson T, el a1．Patient satisfaction after knee arthroplasty：a report on27372knees operated on between1981and1995in Sweden．Acta OrthopScand，2000，71(3)：262-267．
1.Yoon HS, Han CD, Yang IH. Comparison of simultaneous bilateral and staged bilateraltotal knee arthroplasty in terms of perioperative complications. J Arthroplasty,2010,25(2):179-185.
2.Kim YH, Kook HK, Kim JS. Comparison of fixed-bearing and mobile-bearing total kneearthroplasties. Clin Orthop Relat Res.2001Nov;(392):101-15.
3.Aigner C, Windhager R, Pechmann M, et al. The influence of an anterior-posteriorgliding mobile bearing on range of motion after total knee arthroplasty: a prospective,randomized,double-blinded study. J Bone Joint Surg Am.2004;86:2257–2262.
4.Berger RA, Rosenberg AG, Barden RM, et al.Long-term followup of the Miller-Galantetotal knee replacement. Clin Orthp2001,388:58-67.
5.Brassard MF, Insall JN, Scuderi GR, et al. Does modularity affect clinical success? Acomparison with a minimum10-year followup. Clin Orthp2001,388:26-32.
6.Ritter MA, Berend ME, Meding JB, et al.Long-term followup of anatomic graduatedcomponents posterior cruciate-retaining total knee replacement. Clin Orthp2001,388:51-57.
7.van Loon CJ, Hu HP, Van Horn JR, De Waal Malefijt MC. The Geomedic kneeprosthesis: a long-term follow-up study. Acta Orthop Belg.1993;59:40–44.
8.Dennis DA, Clayton ML, O’Donnell S, et al. Posterior cruciate condylar total kneearthroplasty: average11-year follow-up evaluation. Clin Orthop Relat Res.1992;281:168–176.
9.Dixon MC, Brown RR, Parsch D, et al. Modular fixed-bearing total knee arthroplastywith retention of the posterior cruciate ligament. A study of patients followed for aminimum of fifteen years. J Bone Joint Surg Am.2005;87:598–603.
10.Schai PA, Thornhill TS, Scott RD. Total knee arthroplasty with the PFC system: resultsat a minimum of ten years and survivorship analysis. J Bone Joint Surg Br.1998;80:850–858.
11.Sharkey PF, Hozack WJ, Rothman RH, et al. Why are total knee arthroplasties failingtoday? Clin Orthop Relat Res.2002;404:7–13.
12.Dennis DA，Komjslek RD．Mobile-bearing total knee artbroplasty：design factors inminimizing wear．Clin0rthop Relat Res，2006，(452)：70-77．
13.Buechel Sr FF, Buechel Jr FF, Pappas MJ, et al. Twenty-year evaluation of meniscalbearing and rotating platform knee replacements. Clin Orthop2001;388:41-50.
14.Duffy GP, Trousdale RT, Stuart MJ. Total knee arthroplasty in patients55years old oryounger.10-to17-year results.Clin Orthop Relat Res.1998VN356:22-7.
15.Crowder AR, Duffy GP, Trousdale RT. Long-term results of total knee arthroplasty inyoung patients with rheumatoid arthritis. J Arthroplasty.2005;20(Suppl3):12–16.
16.Duffy GP, Trousdale RT, Stuart MJ. Total knee arthroplasty in patients55years old oryounger:10-to17-year results. Clin Orthop Relat Res.1998;356:22–27.
17.Hoffman AA, Heithoff SM, Camargo M. Cementless total knee arthroplasty in patients50years or younger. Clin Orthop Relat Res.2002;404:102–107.
18.Dennis DA, Komistek RD, Colwell CE Jr, et al. In vivo anteroposterior femorotibialtranslation of total knee arthroplasty: a multicenter analysis. Clin Orthop Relat Res.1998;356:47–57.
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1.Yoon HS, Han CD, Yang IH. Comparison of simultaneous bilateral and staged bilateraltotal knee arthroplasty in terms of perioperative complications. J Arthroplasty,2010,25(2):179-185.
2.Kim YH, Kook HK, Kim JS. Comparison of fixed-bearing and mobile-bearing total kneearthroplasties. Clin Orthop Relat Res.2001Nov;(392):101-15.
3.Aigner C, Windhager R, Pechmann M, et al. The influence of an anterior-posteriorgliding mobile bearing on range of motion after total knee arthroplasty: a prospective,randomized,double-blinded study. J Bone Joint Surg Am.2004;86:2257–2262.
4.Berger RA, Rosenberg AG, Barden RM, et al.Long-term followup of the Miller-Galantetotal knee replacement. Clin Orthp2001,388:58-67.
5.Brassard MF, Insall JN, Scuderi GR, et al. Does modularity affect clinical success? Acomparison with a minimum10-year followup. Clin Orthp2001,388:26-32.
6.Ritter MA, Berend ME, Meding JB, et al.Long-term followup of anatomic graduatedcomponents posterior cruciate-retaining total knee replacement. Clin Orthp2001,388:51-57.
7.van Loon CJ, Hu HP, Van Horn JR, De Waal Malefijt MC. The Geomedic kneeprosthesis: a long-term follow-up study. Acta Orthop Belg.1993;59:40–44.
8.Dennis DA, Clayton ML, O’Donnell S, et al. Posterior cruciate condylar total kneearthroplasty: average11-year follow-up evaluation. Clin Orthop Relat Res.1992;281:168–176.
9.Dixon MC, Brown RR, Parsch D, et al. Modular fixed-bearing total knee arthroplastywith retention of the posterior cruciate ligament. A study of patients followed for aminimum of fifteen years. J Bone Joint Surg Am.2005;87:598–603.
10.Schai PA, Thornhill TS, Scott RD. Total knee arthroplasty with the PFC system: resultsat a minimum of ten years and survivorship analysis. J Bone Joint Surg Br.1998;80:850–858.
11.Sharkey PF, Hozack WJ, Rothman RH, et al. Why are total knee arthroplasties failingtoday? Clin Orthop Relat Res.2002;404:7–13.
12.Dennis DA，Komjslek RD．Mobile-bearing total knee artbroplasty：design factors inminimizing wear．Clin0rthop Relat Res，2006，(452)：70-77．
13.Buechel Sr FF, Buechel Jr FF, Pappas MJ, et al. Twenty-year evaluation of meniscalbearing and rotating platform knee replacements. Clin Orthop2001;388:41-50.
14.Duffy GP, Trousdale RT, Stuart MJ. Total knee arthroplasty in patients55years old oryounger.10-to17-year results.Clin Orthop Relat Res.1998VN356:22-7.
15.Crowder AR, Duffy GP, Trousdale RT. Long-term results of total knee arthroplasty inyoung patients with rheumatoid arthritis. J Arthroplasty.2005;20(Suppl3):12–16.
16.Duffy GP, Trousdale RT, Stuart MJ. Total knee arthroplasty in patients55years old oryounger:10-to17-year results. Clin Orthop Relat Res.1998;356:22–27.
17.Hoffman AA, Heithoff SM, Camargo M. Cementless total knee arthroplasty in patients50years or younger. Clin Orthop Relat Res.2002;404:102–107.
18.Dennis DA, Komistek RD, Colwell CE Jr, et al. In vivo anteroposterior femorotibialtranslation of total knee arthroplasty: a multicenter analysis. Clin Orthop Relat Res.1998;356:47–57.
19.Bartel DL, Bicknell VL, Wright TM. The effect of conformity, thickness and materialon stresses in ultra-high molecular weight components for total joint replacement. JBone Joint Surg Am.1986;68:1041–1051.
20.D’Lima DD, Chen PC, Colwell CW Jr. Polyethylene contact stress, articular congruity,and knee alignment. Clin Orthop Relat Res.2001;392:232–238.
21.Insall JN, Scuderi GR, Komistek RD, et al. Correlation between condylar lift-off andfemoral component alignment. Clin Orthop Relat Res.2002;403:143–152.
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