In Vivo Determination of 3D Patellofemoral Mechanics (Patella)
17 ottobre 2019 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Tipo di studio
Osservativo
Iscrizione (Effettivo)
30
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Colorado
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Denver, Colorado, Stati Uniti, 80210
- Porter Adventist Hospital
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Denver, Colorado, Stati Uniti, 80210
- Colorado Joint Replacement
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Tennessee
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Knoxville, Tennessee, Stati Uniti, 37996
- Perkins Hall
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Knoxville, Tennessee, Stati Uniti, 37996
- Science and Engineering Research Facility
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 20 anni a 85 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
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.
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Solo caso
- Prospettive temporali: Retrospettiva
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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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)
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Patella Flexion With Respect to Femur
Lasso di tempo: 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.
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Patella Rotation With Respect to Femur
Lasso di tempo: 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
Lasso di tempo: 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 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.
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Normalized Medial Patella Contact Point Translation
Lasso di tempo: 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 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.
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Normalized Lateral Patella Contact Point Translation
Lasso di tempo: 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 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.
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Investigatori
- Investigatore principale: Richard D. Komistek, Ph D, The University of Tennessee
- Investigatore principale: Douglas Dennis, MD, Colorado Joint Replacement, Porter Adventist Hosp
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 febbraio 2011
Completamento primario (Effettivo)
1 settembre 2011
Completamento dello studio (Effettivo)
1 settembre 2011
Date di iscrizione allo studio
Primo inviato
3 febbraio 2011
Primo inviato che soddisfa i criteri di controllo qualità
4 febbraio 2011
Primo Inserito (Stima)
7 febbraio 2011
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
29 ottobre 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
17 ottobre 2019
Ultimo verificato
1 ottobre 2019
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 10035/IIS-000126
- R011373372 (Altro numero di sovvenzione/finanziamento: DePuy Orthopaedics)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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