In Vivo Determination of 3D Patellofemoral Mechanics (Patella)
17 de outubro de 2019 atualizado por: Richard Komistek, The University of Tennessee, Knoxville
This study will analyze the tibio-femoral and patellofemoral (motion) and mechanics (forces) of participants having a normal knee or a total knee arthroplasty (TKA) using one or two different (TKA) devices Low Contract Stress (LCS) Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA).
All knees will be analyzed using an image matching technique that will convert a two-dimensional (2D) fluoroscopic image into a three-dimensional (3D) image.
In conjunction with the fluoroscopic analysis, electromyography (EMG) data, and ground reaction force (GRF) data will all be allow for a complete analysis of the knee joints.
These results will help the orthopaedic community better understand knee motion so they can improve testing on existing implants and develop future implants that will further enhance patients' lives.
Visão geral do estudo
Status
Concluído
Tipo de estudo
Observacional
Inscrição (Real)
30
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Colorado
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Denver, Colorado, Estados Unidos, 80210
- Porter Adventist Hospital
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Denver, Colorado, Estados Unidos, 80210
- Colorado Joint Replacement
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Tennessee
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Knoxville, Tennessee, Estados Unidos, 37996
- Perkins Hall
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Knoxville, Tennessee, Estados Unidos, 37996
- Science and Engineering Research Facility
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
20 anos a 85 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Subjects recruited from patients chosen from practice of Dr.'s Dennis and Haas at Colorado Joint Replacement for implanted knee, having either one of the two kinds of implants specified.
Descrição
Inclusion Criteria:
- Patients must be at least six months post-operative.
- Potential subjects will have a body weight of less than 250 lbs.
- Candidates must have an AKS score >70 post-operatively.
- Patients must have passive flexion of at least 100.
- Implanted group must have either an LCS PS RP TKA, having an anatomical patella, or Sigma PS RP TKA; or normal knee group must have normal knee.
- Must be willing to sign both Informed Consent and HIPAA forms.
Exclusion Criteria:
- Pregnant females.
- Subjects not meeting study requirements.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Caso-somente
- Perspectivas de Tempo: Retrospectivo
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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Knee Prosthesis LCS PS RP TKA
Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
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Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
|
|
Knee Prosthesis Sigma PS RP TKA
Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
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Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
|
|
Control
Subjects with normal knees
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Patella Flexion With Respect to Femur
Prazo: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
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Full extension to maximum flexion.
Degrees of flexion analyzed for participants with and without implants.
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Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
|
|
Patella Rotation With Respect to Femur
Prazo: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
|
Patellar rotation from full extension to maximum flexion for subjects with and without implants.
A positive measurement of patellar rotation refers to positive flexion of the patella about the medial-lateral axis, where the patella component rotates so that the top of the patella rotates toward the femur and the bottom rotates away.
Conversely, a negative measurement refers to negative flexion of the patella about this axis, where the patellar component rotates so that the top of the patella moves away from the femur and the bottom moves towards.
|
Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
|
|
Patella Tilt With Respect to Femur
Prazo: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
|
full extension to maximum flexion for participants with and without implants.
|
Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
|
|
Normalized Medial Patella Contact Point Translation
Prazo: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
|
full extension to maximum flexion for participants with and without implants.
Position of the patellar contact point was determined by locating the closest point to the femur on the patella throughout flexion.
There are 2 patello-femoral contact points: a point on the medial aspect of the patella and a point on the lateral aspect of the patella.
Throughout flexion, the medial contact point generally moves closer to the top of the patella (hence the positive value for the results).
The translation of this contact point is normalized to report a ratio between -1 and 1.
In other words, the distance the point has traveled compared to the total height of the patella.
For example, if the patella is 8 cm in height and the point travels approximately 2 cm upwards during flexion, the value would be reported as +2/8 = +0.25.
Definition of normalized: "multiply (a series, function, or item of data) by a factor that makes the norm or some associated quantity such as an integral equal
|
Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
|
|
Normalized Lateral Patella Contact Point Translation
Prazo: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
|
full extension to maximum flexion for participants with and without implants.
Position of patellar contact point was determined by locating closest point to femur on patella throughout flexion.
There are 2 patello-femoral contact points: 1 point on the medial aspect of the patella and 1 point on the lateral aspect of the patella.
Throughout flexion, lateral contact point generally moves closer to the top of the patella (hence, the positive value for the results).
The translation of this contact point is normalized to report a ratio between -1 and 1.
The distance the point has traveled compared to the total height of the patella.
For example, if the patella is 8 cm in height and the point travels approximately 2 cm upwards during flexion, the value would be reported as +2/8 = +0.25.
Definition of normalized: "multiply (a series, function, or item of data) by a factor that makes the norm or some associated quantity such as an integral equal to a desired value (usually 1)."
|
Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Richard D. Komistek, Ph D, The University of Tennessee
- Investigador principal: Douglas Dennis, MD, Colorado Joint Replacement, Porter Adventist Hosp
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de fevereiro de 2011
Conclusão Primária (Real)
1 de setembro de 2011
Conclusão do estudo (Real)
1 de setembro de 2011
Datas de inscrição no estudo
Enviado pela primeira vez
3 de fevereiro de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
4 de fevereiro de 2011
Primeira postagem (Estimativa)
7 de fevereiro de 2011
Atualizações de registro de estudo
Última Atualização Postada (Real)
29 de outubro de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
17 de outubro de 2019
Última verificação
1 de outubro de 2019
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 10035/IIS-000126
- R011373372 (Número de outro subsídio/financiamento: DePuy Orthopaedics)
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