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Examining Effects of Spinal Fusion on Outcomes Following Total Hip Replacement

26 mars 2020 uppdaterad av: 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.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Förväntat)

160

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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.
Diagnostiskt test: X-Ray Imaging
X-Ray imaging in the following positions: Lateral standing, lateral seated, standard standing AP pelvis and AP pelvis lying down.
Övrig: 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.
Diagnostiskt test: X-Ray Imaging
X-Ray imaging in the following positions: Lateral standing, lateral seated, standard standing AP pelvis and AP pelvis lying down.
Övrig: 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.
Diagnostiskt test: X-Ray Imaging
X-Ray imaging in the following positions: Lateral standing, lateral seated, standard standing AP pelvis and AP pelvis lying down.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Implant positioning
Tidsram: 6months or greater post-operative
Radiographic assessment (x-ray cup orientation measurements)
6months or greater post-operative

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Ottawa Hospital Research Institute

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

15 maj 2017

Primärt slutförande (Förväntat)

1 november 2020

Avslutad studie (Förväntat)

1 juni 2021

Studieregistreringsdatum

Först inskickad

21 juli 2017

Först inskickad som uppfyllde QC-kriterierna

1 augusti 2017

Första postat (Faktisk)

7 augusti 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

30 mars 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

26 mars 2020

Senast verifierad

1 mars 2020

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • 20170312

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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