- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00689286
BION Treatment of Knee Osteoarthritis
BION Implantable Microstimulator System
Studieoversikt
Detaljert beskrivelse
Studietype
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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California
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Los Angeles, California, Forente stater, 90033
- USC University Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Subject presents with osteoarthritis of the knee with severity defined as Kellgren-Lawrence grade 3-4.
- Subject is between 18 and 75 years old.
- Attending physician considers the subject in general good health (other than knee joint osteoarthritis).
- Subject is mentally capable of understanding the goals and the application of therapy.
- Subject is able to apply the therapy (with or without help) in the home setting.
- Subject is willing and capable of giving informed consent.
- Subject is willing and capable of traveling to testing center at the schedule described above and detailed in Table 2.
Exclusion Criteria:
- Subject is pregnant, nursing, or planning to become pregnant in the next 12 months.
- Subject has an electronic implant (e.g. cardiac pacemaker, etc.).
- Subject has metallic implant (e.g. plates, hip joints) in the buttock or upper leg.
- Subject has a history of falling.
- Subject has medical conditions other than OA affecting the legs that could affect treatment or mobility.
- Subject is 40% or more above the ideal weight recommended by Metropolitan Life.
- Subject has cancer.
- Subject is currently enrolled in another clinical trial or research study that involves therapy or intervention which would affect lower extremity mobility.
- Subject has bilateral knee osteoarthritis.
- Subject is taking pain medications with dosage not stable for one month.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: BION "twitch" stimulation
The first group will have a stimulation paradigm like that used in a previous feasibility study that preceded the proposed trial, using low-frequency (1-5 PPS) "twitch" stimulation.
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They will be divided into three groups. Two groups of experimental subjects will receive stimulation using BIONs. The first group will have a stimulation paradigm like that used in a previous feasibility study that preceded the proposed trial, using low-frequency (1-5 PPS) "twitch" stimulation. The second group will have a stimulation paradigm in which tetanic-frequency stimulation (25-50 PPS) is used to produce fused muscle contractions. A third group of experimental subjects will have a standardized program of voluntary exercise. In Groups 1 and 2, the femoral nerve will be stimulated electrically according to the assigned protocol during the 12 week experimental period after implantation of the devices. Individuals assigned to Group 3, receiving conventional exercise therapy for 12 weeks, will be allowed to receive BIONs at the end of the trial, providing they request BION therapy and they have been at least minimally compliant with the exercises. |
Eksperimentell: BION tetanic-frequency stimulation
The second group will have a stimulation paradigm in which tetanic-frequency stimulation (25-50 PPS) is used to produce fused muscle contractions.
|
They will be divided into three groups. Two groups of experimental subjects will receive stimulation using BIONs. The first group will have a stimulation paradigm like that used in a previous feasibility study that preceded the proposed trial, using low-frequency (1-5 PPS) "twitch" stimulation. The second group will have a stimulation paradigm in which tetanic-frequency stimulation (25-50 PPS) is used to produce fused muscle contractions. A third group of experimental subjects will have a standardized program of voluntary exercise. In Groups 1 and 2, the femoral nerve will be stimulated electrically according to the assigned protocol during the 12 week experimental period after implantation of the devices. Individuals assigned to Group 3, receiving conventional exercise therapy for 12 weeks, will be allowed to receive BIONs at the end of the trial, providing they request BION therapy and they have been at least minimally compliant with the exercises. |
Ingen inngripen: Standardized program
A third group of experimental subjects will have a standardized program of voluntary exercise.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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quadriceps isometric strength
Tidsramme: pre-exercise, 4w, 8w, 12w
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pre-exercise, 4w, 8w, 12w
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Gait velocity Gait endurance Pain WOMAC
Tidsramme: pre-exercise, 8w, 12w
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pre-exercise, 8w, 12w
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Lucinda Baker, Ph.D, University of Southern California
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BT5
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