In Vivo Determination of 3D Patellofemoral Mechanics (Patella)
17. oktober 2019 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Faktiske)
30
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Colorado
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Denver, Colorado, Forente stater, 80210
- Porter Adventist Hospital
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Denver, Colorado, Forente stater, 80210
- Colorado Joint Replacement
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Tennessee
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Knoxville, Tennessee, Forente stater, 37996
- Perkins Hall
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Knoxville, Tennessee, Forente stater, 37996
- Science and Engineering Research Facility
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
20 år til 85 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Bare etui
- Tidsperspektiver: Retrospektiv
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Knee Prosthesis LCS PS RP TKA
Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
|
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)
|
Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
|
|
Control
Subjects with normal knees
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Patella Flexion With Respect to Femur
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Richard D. Komistek, Ph D, The University of Tennessee
- Hovedetterforsker: Douglas Dennis, MD, Colorado Joint Replacement, Porter Adventist Hosp
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. februar 2011
Primær fullføring (Faktiske)
1. september 2011
Studiet fullført (Faktiske)
1. september 2011
Datoer for studieregistrering
Først innsendt
3. februar 2011
Først innsendt som oppfylte QC-kriteriene
4. februar 2011
Først lagt ut (Anslag)
7. februar 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
29. oktober 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. oktober 2019
Sist bekreftet
1. oktober 2019
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 10035/IIS-000126
- R011373372 (Annet stipend/finansieringsnummer: DePuy Orthopaedics)
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