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Examining Effects of Spinal Fusion on Outcomes Following Total Hip Replacement

26. marts 2020 opdateret af: Wade Gofton, Ottawa Hospital Research Institute

Examining Effects of Spinal Arthrodesis on Outcomes Following Total Hip Arthroplasty

The purpose of the study is to explore the long term functional status of people who have had both a spinal fusion procedure and a total hip replacement.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The purpose of the study is to explore the long term functional status of people who have had both a spinal fusion procedure and a total hip replacement. Studies have found that those who have received spinal fusion may have worse outcomes following a total hip replacement than those who have not received a spinal fusion. The information obtained from this study will allow surgeons and researchers to better understand why some who've had a spine fusion have more complications post total hip replacement compared to those who did not have spinal fusion surgery.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

160

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y4E9
        • Rekruttering
        • Ottawa Hospital Research Institute
        • Kontakt:
          • Research Manager
          • Telefonnummer: 613-737-8920
        • Ledende efterforsker:
          • Wade Gofton, MD FRCSC MEd
        • Underforsker:
          • Paul Beaule, MD FRCSC
        • Underforsker:
          • George Grammatopoulos, BMBBS DPhil Oxon MRCS FRCS
        • Underforsker:
          • Matthew Coyle, MD
        • Underforsker:
          • Mario Lamontagne, PhD
        • Underforsker:
          • Philippe Phan, MD PhD FRCSC

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Approximately 70 patients who underwent total hip arthroplasty (THA) and spine fusion (SF) surgery will be called by the surgeon or research team and asked if they wish to participate in the study. A second group of approximately 45 patients who have only had a THA (and no SF) will serve as a comparison group. A third group of approximately 45 patients who have only had an SF surgery (and no THA) will also be recruited.

Beskrivelse

Inclusion Criteria:

  • Willing to come to the Civic Campus for a surgical follow-up visit
  • Speaks English and/or French
  • Group 1 patients must have had a spine fusion (SF) and total hip arthroplasty (THA)
  • Group 2 patients must have had a total hip replacement (THA) and no history of spine fusion (SF)
  • Group 3 patients must have had a spine fusion (SF) and no history of total hip arthroplasty (THA)

Exclusion Criteria:

  • Patient does not meet all 'inclusion' criteria
  • Patient is unable to answer questionnaires
  • Unable to get x-rays for other medical reasons
  • Severe dementia

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Spine Fusion and Total Hip Replacement
Any patient who has undergone spine fusion (SF) and total hip arthroplasty (THA). Patients will undergo x-ray imaging and complete functional assessment questionnaires. Patients may additionally be asked to participate in a gait analysis in a Human Movement Laboratory.
Diagnostisk test: X-Ray Imaging
X-Ray imaging in the following positions: Lateral standing, lateral seated, standard standing AP pelvis and AP pelvis lying down.
Andet: Gait Analysis
Certain patients may be asked to participate in a motion analysis procedure at the Human Movement Laboratory at the University of Ottawa. This procedure takes approximately 1.5 hours and you will only be asked to participate in the motion analysis procedure once. Participants will change into a custom-designed tight body suit, which has reflective markers on its surface for infrared video capture. Participants will then have pairs of surface electromyography (EMG) electrodes placed on certain areas of the skin on the legs and on the back. Wearing the EMG electrodes and marker suit, participants will perform 5 trials of walking on a level walkway, walking up and down a 3-step staircase, sitting from a standing position, and standing from a seated position.
Total Hip Replacement Group
Any patient who has had THA only (no spine fusion surgery). Patients will undergo x-ray imaging and complete functional assessment questionnaires. Patients may additionally be asked to participate in a gait analysis in a Human Movement Laboratory.
Diagnostisk test: X-Ray Imaging
X-Ray imaging in the following positions: Lateral standing, lateral seated, standard standing AP pelvis and AP pelvis lying down.
Andet: Gait Analysis
Certain patients may be asked to participate in a motion analysis procedure at the Human Movement Laboratory at the University of Ottawa. This procedure takes approximately 1.5 hours and you will only be asked to participate in the motion analysis procedure once. Participants will change into a custom-designed tight body suit, which has reflective markers on its surface for infrared video capture. Participants will then have pairs of surface electromyography (EMG) electrodes placed on certain areas of the skin on the legs and on the back. Wearing the EMG electrodes and marker suit, participants will perform 5 trials of walking on a level walkway, walking up and down a 3-step staircase, sitting from a standing position, and standing from a seated position.
Spine Fusion Only Group
Any patient who has had spine fusion only (no hip replacement surgery). Patients will undergo x-ray imaging and complete functional assessment questionnaires.
Diagnostisk test: X-Ray Imaging
X-Ray imaging in the following positions: Lateral standing, lateral seated, standard standing AP pelvis and AP pelvis lying down.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Implant positioning
Tidsramme: 6months or greater post-operative
Radiographic assessment (x-ray cup orientation measurements)
6months or greater post-operative

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Hip dysfunction and osteoarthritis outcome score (HOOS)
Tidsramme: 6months or greater post-operative
Disease-specific quality of life measure
6months or greater post-operative
Oxford Hip Score
Tidsramme: 6months or greater post-operative
Disease-specific quality of life measure
6months or greater post-operative
SF-12 Questionnaire
Tidsramme: 6months or greater post-operative
Patient-reported overall quality of life measure
6months or greater post-operative
Oswestry low back disability questionnaire
Tidsramme: 6months or greater post-operative
Assessment of low back pain
6months or greater post-operative

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ottawa Hospital Research Institute

Efterforskere

  • Ledende efterforsker: Wade Gofton, MD, FRCSC, The Ottawa Hospital Research Institute

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. maj 2017

Primær færdiggørelse (Forventet)

1. november 2020

Studieafslutning (Forventet)

1. juni 2021

Datoer for studieregistrering

Først indsendt

21. juli 2017

Først indsendt, der opfyldte QC-kriterier

1. august 2017

Først opslået (Faktiske)

7. august 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. marts 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. marts 2020

Sidst verificeret

1. marts 2020

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 20170312

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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Kliniske forsøg med Spinal Fusion

Kliniske forsøg med X-Ray Imaging

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