In Vivo Determination of 3D Patellofemoral Mechanics (Patella)
17 octobre 2019 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Type d'étude
Observationnel
Inscription (Réel)
30
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Colorado
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Denver, Colorado, États-Unis, 80210
- Porter Adventist Hospital
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Denver, Colorado, États-Unis, 80210
- Colorado Joint Replacement
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Tennessee
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Knoxville, Tennessee, États-Unis, 37996
- Perkins Hall
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Knoxville, Tennessee, États-Unis, 37996
- Science and Engineering Research Facility
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
20 ans à 85 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cas uniquement
- Perspectives temporelles: Rétrospective
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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)
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Control
Subjects with normal knees
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Patella Flexion With Respect to Femur
Délai: 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
Délai: 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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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.
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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.
|
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Patella Tilt With Respect to Femur
Délai: 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.
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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.
|
|
Normalized Medial Patella Contact Point Translation
Délai: 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
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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.
|
|
Normalized Lateral Patella Contact Point Translation
Délai: 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)."
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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.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Richard D. Komistek, Ph D, The University of Tennessee
- Chercheur principal: Douglas Dennis, MD, Colorado Joint Replacement, Porter Adventist Hosp
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 février 2011
Achèvement primaire (Réel)
1 septembre 2011
Achèvement de l'étude (Réel)
1 septembre 2011
Dates d'inscription aux études
Première soumission
3 février 2011
Première soumission répondant aux critères de contrôle qualité
4 février 2011
Première publication (Estimation)
7 février 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
29 octobre 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
17 octobre 2019
Dernière vérification
1 octobre 2019
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 10035/IIS-000126
- R011373372 (Autre subvention/numéro de financement: DePuy Orthopaedics)
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