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Examining Effects of Spinal Fusion on Outcomes Following Total Hip Replacement

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ClinicalTrials.gov Identifier: NCT03240484
Recruitment Status : Recruiting
First Posted : August 7, 2017
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Wade Gofton, Ottawa Hospital Research Institute

Tracking Information
First Submitted Date July 21, 2017
First Posted Date August 7, 2017
Last Update Posted Date July 8, 2019
Actual Study Start Date May 15, 2017
Estimated Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 1, 2017)
Implant positioning [ Time Frame: 6months or greater post-operative ]
Radiographic assessment (x-ray cup orientation measurements)
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03240484 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 18, 2017)
  • Hip dysfunction and osteoarthritis outcome score (HOOS) [ Time Frame: 6months or greater post-operative ]
    Disease-specific quality of life measure
  • Oxford Hip Score [ Time Frame: 6months or greater post-operative ]
    Disease-specific quality of life measure
  • SF-12 Questionnaire [ Time Frame: 6months or greater post-operative ]
    Patient-reported overall quality of life measure
  • Oswestry low back disability questionnaire [ Time Frame: 6months or greater post-operative ]
    Assessment of low back pain
Original Secondary Outcome Measures
 (submitted: August 1, 2017)
Patient functionality [ Time Frame: 6months or greater post-operative ]
Patient reported outcome measures (questionnaires)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Examining Effects of Spinal Fusion on Outcomes Following Total Hip Replacement
Official Title Examining Effects of Spinal Arthrodesis on Outcomes Following Total Hip Arthroplasty
Brief Summary 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.
Detailed Description 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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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.
Condition
  • Spinal Fusion
  • Total Hip Replacement
Intervention
  • Diagnostic Test: X-Ray Imaging
    X-Ray imaging in the following positions: Lateral standing, lateral seated, standard standing AP pelvis and AP pelvis lying down.
  • Other: 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.
Study Groups/Cohorts
  • 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.
    Interventions:
    • Diagnostic Test: X-Ray Imaging
    • Other: Gait Analysis
  • 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.
    Interventions:
    • Diagnostic Test: X-Ray Imaging
    • Other: Gait Analysis
  • 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.
    Intervention: Diagnostic Test: X-Ray Imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 28, 2018)
160
Original Estimated Enrollment
 (submitted: August 1, 2017)
90
Estimated Study Completion Date December 1, 2020
Estimated Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Research Manager 613-737-8920 jdobransky@ohri.ca
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03240484
Other Study ID Numbers 20170312
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Wade Gofton, Ottawa Hospital Research Institute
Study Sponsor Ottawa Hospital Research Institute
Collaborators Not Provided
Investigators
Principal Investigator: Wade Gofton, MD, FRCSC The Ottawa Hospital Research Institute
PRS Account Ottawa Hospital Research Institute
Verification Date July 2019