In Vivo Determination of 3D Patellofemoral Mechanics (Patella)
17. Oktober 2019 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
30
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Colorado
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Denver, Colorado, Vereinigte Staaten, 80210
- Porter Adventist Hospital
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Denver, Colorado, Vereinigte Staaten, 80210
- Colorado Joint Replacement
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Tennessee
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Knoxville, Tennessee, Vereinigte Staaten, 37996
- Perkins Hall
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Knoxville, Tennessee, Vereinigte Staaten, 37996
- Science and Engineering Research Facility
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
20 Jahre bis 85 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
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.
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: Nur Fall
- Zeitperspektiven: Retrospektive
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Patella Flexion With Respect to Femur
Zeitfenster: 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
Zeitfenster: 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.
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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
Zeitfenster: 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
Zeitfenster: 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
|
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
Zeitfenster: 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.
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Mitarbeiter
Ermittler
- Hauptermittler: Richard D. Komistek, Ph D, The University of Tennessee
- Hauptermittler: Douglas Dennis, MD, Colorado Joint Replacement, Porter Adventist Hosp
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Februar 2011
Primärer Abschluss (Tatsächlich)
1. September 2011
Studienabschluss (Tatsächlich)
1. September 2011
Studienanmeldedaten
Zuerst eingereicht
3. Februar 2011
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
4. Februar 2011
Zuerst gepostet (Schätzen)
7. Februar 2011
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
29. Oktober 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
17. Oktober 2019
Zuletzt verifiziert
1. Oktober 2019
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- 10035/IIS-000126
- R011373372 (Andere Zuschuss-/Finanzierungsnummer: DePuy Orthopaedics)
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