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- Ensaio Clínico NCT04904640
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
Visão geral do estudo
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Bologna, Itália, 40136
- Chirurgia Protesica e dei Reimpianti di Anca e Ginocchio, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Correct Reconstruction CLS
Prazo: 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
Prazo: 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
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Combined Anteversion CLS
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Francesco Traina, Professor, IRCCS Istituto Ortopedico Rizzoli
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 29/2021/Oss/IOR
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