- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00152152
Use of Radiostereometric Analysis Beads (RSA) to Measure Motion in the Spine, Following Lumbar Spinal Surgery
Use of Radiostereometric Analysis (RSA) for Measuring Spinal Motion Following Lumbar Spinal Surgery
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Assessment of segmental spinal motion has been and continues to be a difficult clinical problem. X-ray measurement error of up to 10 degrees for simple measurements for flexion, extension and side bending have been recorded. It is extremely difficult to measure small changes in vertebral alignment that may prove to have clinical significance. The measurement accuracy of the RSA technique far exceeds any manual techniques to date. RSA allows the surgeon to monitor spatial relationships within the spine over time with a much higher accuracy then conventional techniques.
This is a non-randomized prospective study design looking at the use of RSA in spinal surgery patients. Subjects in this study will undergo their indicated surgery. Prior to closure, they will be implanted with tantalum beads, which will serve as landmarks when the RSA film pairs are taken post-operatively. The subjects will have standard post-operative x-rays 6 weeks-3 months post-op and again at 12 months post-op. Yearly visits after this are anticipated for 5-10 years with proper funding.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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New York
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Syracuse, New York, Forenede Stater, 13202
- SUNY Upstate Medical University
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients undergoing Spinal fusion or discectomy
Exclusion Criteria:
- pregnant women
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tidsperspektiver: Fremadrettet
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Bruce E. Fredrickson, MD, State University of New York - Upstate Medical University
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- SUNY UMU IRB# 4715
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