Biomechanical Reconstruction of Three Different Hip Stem Designs in Hip Dysplasia Using a 3D CT-based Planning Software (CTdevice)
Evaluation of the Reconstruction of Biomechanical Parameters Provided by Three Different Hip Stem Designs in Developmental Hip Dysplasia Using a 3D CT-based Software for Surgical Planning
研究概览
详细说明
Pre-operative planning in hip arthroplasty with dedicated software is a useful guide to provide a better reconstruction of the biomechanical parameters of the replaced hip and to optimize the choice of component, improving the geometric understanding of the hip anatomy and the interaction between the native morphological structure and the prosthetic component.
The use of a 3D CT-based software for pre-operative planning may provide a better knowledge of the hip anatomy, simulating the biomechanical parameters more closely than a 2D X-ray-based software. In addition, it is the only way to anticipate the correct interaction between the prosthetic components, or the combined anteversion, a key factor in preventing implant instability.
Severe hip deformities, like developmental hip dysplasia, may not be adequately reconstructed by every implant and 3D pre-operative CT may increase the three-dimensional anatomical knowledge of the hip, improving the choice of the correct implant and possibly reducing the possible consequences of intra and post-operative complications.
Therefore, the purpose of this study is to pre-operatively plan, in a random series of 200 native pelvis and thigh CT scans performed in patients with hip dysplasia, 3 different types of hip stem designs using the 3D Hip-Op software, with the aim of analyzing, on the CT simulations, the percentage of adequate reconstruction of the optimal biomechanical parameters (combined anteversion between 25°-50°, global offset not inferior to 12% of the native offset, leg lengthening not superior to 3 cm, sagittal and coronal tilt not superior to +/-5°, canal filling not inferior to 80%). The percentage of every stem design providing the optimal reconstruction in dysplastic hips (all the 5 parameters matched) will be assessed. The single parameters, especially the combined anteversion, the offset restoration and the leg lengthening, will be assessed for every simulation.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Bologna、意大利、40136
- Chirurgia Protesica e dei Reimpianti di Anca e Ginocchio, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- definition of developmental hip dysplasia according to Wiberg (center edge angle <20°)
- pre-operative CT scan extended from the fourth lumbar vertebra to the tibial plateaus
Exclusion Criteria:
- other types of hip pathologies
- inadequate Ct scans
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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CLS stem
CLS Zimmer stem implantation (single wedge, tapered stem) using the 3D CT based software for surgical pre-operative planning
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In every hip (with appropriate CT scan), 3 different stem designs will be positioned using a 3D Ct based software for surgical pre-operative planning.
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Wagner cone stem
Wagner cone Zimmer stem implantation (conical tapered stem) using the 3D CT based software for surgical pre-operative planning
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In every hip (with appropriate CT scan), 3 different stem designs will be positioned using a 3D Ct based software for surgical pre-operative planning.
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Aptafix stem
Aptafix Ortho stem implantation (anatomical stem) using the 3D CT based software for surgical pre-operative planning
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In every hip (with appropriate CT scan), 3 different stem designs will be positioned using a 3D Ct based software for surgical pre-operative planning.
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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 |
---|---|---|
Correct Reconstruction CLS
大体时间:Day 0
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Percentage of hips correctly reconstructed using CLS stem: the correctly reconstructed hip should have combined anteversion between 25° and 50°, global offset not inferior to 12% of the native offset, leg lengthening not superior to 3 cm, sagittal and coronal tilt not superior to +/-5°, canal filling not inferior to 80% (all the 5 parameters should be present at the same time).
Minimum-maximum values (as percentage %): 0-100.
100 is the best result, 0 the worst
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Day 0
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Correct Reconstruction Wagner Cone
大体时间:Day 0
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Percentage of hips correctly reconstructed using CLS stem: the correctly reconstructed hip should have combined anteversion between 25° and 50°, global offset not inferior to 12% of the native offset, leg lengthening not superior to 3 cm, sagittal and coronal tilt not superior to +/-5°, canal filling not inferior to 80% (all the 5 parameters should be present at the same time).
Minimum-maximum values (as percentage %): 0-100.
100 is the best result, 0 the worst
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Day 0
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Correct Reconstruction Aptafix
大体时间:Day 0
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Percentage of hips correctly reconstructed using CLS stem: the correctly reconstructed hip should have combined anteversion between 25° and 50°, global offset not inferior to 12% of the native offset, leg lengthening not superior to 3 cm, sagittal and coronal tilt not superior to +/-5°, canal filling not inferior to 80% (all the 5 parameters should be present at the same time).
Minimum-maximum values (as percentage %): 0-100.
100 is the best result, 0 the worst
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Day 0
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Combined Anteversion CLS
大体时间:Day 0
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Percentage of hips with adequate combined anteversion according to Dorr (25-50°) and Widmer (<37°) using CLS stems.
Minimum-maximum values (as percentage %): 0-100.
100 is the best result, 0 is the worst
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Day 0
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Combined Anteversion Wagner Cone
大体时间:Day 0
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Percentage of hips with adequate combined anteversion according to Dorr (25-50°) and Widmer (<37°) using CLS stems.
Minimum-maximum values (as percentage %): 0-100.
100 is the best result, 0 is the worst
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Day 0
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Combined Anteversion Aptafix
大体时间:Day 0
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Percentage of hips with adequate combined anteversion according to Dorr (25-50°) and Widmer (<37°) using CLS stems.
Minimum-maximum values (as percentage %): 0-100.
100 is the best result, 0 is the worst
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Day 0
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Offset CLS
大体时间:Day 0
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Percentage of hips with acetabular+femoral offset not inferior to 12% of the native value using CLS stems.
Minimum-maximum values (as percentage %): 0-100.
100 is the best result, 0 is the worst
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Day 0
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Offset Wagner Cone
大体时间:Day 0
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Percentage of hips with acetabular+femoral offset not inferior to 12% of the native value using CLS stems.
Minimum-maximum values (as percentage %): 0-100.
100 is the best result, 0 is the worst
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Day 0
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Offset Aptafix
大体时间:Day 0
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Percentage of hips with acetabular+femoral offset not inferior to 12% of the native value using CLS stems.
Minimum-maximum values (as percentage %): 0-100.
100 is the best result, 0 is the worst
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Day 0
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Leg Lengthening CLS
大体时间:Day 0
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Percentage of hips with leg lengthening not superior to 3 cm using CLS stems.
Minimum-maximum values (as percentages %): 0-100.
100 is the best result, 0 is the worst
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Day 0
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Leg Lengthening Wagner Cone
大体时间:Day 0
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Percentage of hips with leg lengthening not superior to 3 cm using CLS stems.
Minimum-maximum values (as percentages %): 0-100.
100 is the best result, 0 is the worst
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Day 0
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Leg Lengthening Aptafix
大体时间:Day 0
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Percentage of hips with leg lengthening not superior to 3 cm using CLS stems.
Minimum-maximum values (as percentages %): 0-100.
100 is the best result, 0 is the worst
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Day 0
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合作者和调查者
调查人员
- 研究主任:Francesco Traina, Professor、IRCCS Istituto Ortopedico Rizzoli
出版物和有用的链接
一般刊物
- Taniguchi N, Jinno T, Koga D, Hagino T, Okawa A, Haro H. Cementless Hip Stem Anteversion in the Dysplastic Hip: A Comparison of Tapered Wedge vs Metaphyseal Filling. J Arthroplasty. 2017 May;32(5):1547-1552. doi: 10.1016/j.arth.2016.12.020. Epub 2016 Dec 22.
- Argenson JN, Ryembault E, Flecher X, Brassart N, Parratte S, Aubaniac JM. Three-dimensional anatomy of the hip in osteoarthritis after developmental dysplasia. J Bone Joint Surg Br. 2005 Sep;87(9):1192-6. doi: 10.1302/0301-620X.87B9.15928.
- Sugano N, Takao M, Sakai T, Nishii T, Miki H. Does CT-based navigation improve the long-term survival in ceramic-on-ceramic THA? Clin Orthop Relat Res. 2012 Nov;470(11):3054-9. doi: 10.1007/s11999-012-2378-4.
- Castagnini F, Valente G, Crimi G, Taddei F, Bordini B, Stea S, Toni A. Component positioning and ceramic damage in cementless ceramic-on-ceramic total hip arthroplasty. J Orthop Sci. 2019 Jul;24(4):643-651. doi: 10.1016/j.jos.2018.12.011. Epub 2019 Jan 4.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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