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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

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.

Condition or disease Intervention/treatment
Spinal Fusion Total Hip Replacement Diagnostic Test: X-Ray Imaging Other: Gait Analysis

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.

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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Examining Effects of Spinal Arthrodesis on Outcomes Following Total Hip Arthroplasty
Actual Study Start Date : May 15, 2017
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: X-Rays

Group/Cohort Intervention/treatment
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.
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.

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.
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.

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.
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.




Primary Outcome Measures :
  1. Implant positioning [ Time Frame: 6months or greater post-operative ]
    Radiographic assessment (x-ray cup orientation measurements)


Secondary Outcome Measures :
  1. Hip dysfunction and osteoarthritis outcome score (HOOS) [ Time Frame: 6months or greater post-operative ]
    Disease-specific quality of life measure

  2. Oxford Hip Score [ Time Frame: 6months or greater post-operative ]
    Disease-specific quality of life measure

  3. SF-12 Questionnaire [ Time Frame: 6months or greater post-operative ]
    Patient-reported overall quality of life measure

  4. Oswestry low back disability questionnaire [ Time Frame: 6months or greater post-operative ]
    Assessment of low back pain



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03240484


Contacts
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Contact: Research Manager 613-737-8920 jdobransky@ohri.ca

Locations
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Canada, Ontario
Ottawa Hospital Research Institute Recruiting
Ottawa, Ontario, Canada, K1Y4E9
Contact: Research Manager    613-737-8920      
Principal Investigator: Wade Gofton, MD, FRCSC, MEd         
Sub-Investigator: Paul Beaule, MD, FRCSC         
Sub-Investigator: George Grammatopoulos, BSc, MBBS, DPhil(Oxon)         
Sub-Investigator: Matthew Coyle, MD         
Sub-Investigator: Mario Lamontagne, PhD         
Sub-Investigator: Philippe Phan, MD, PhD, FRCSC         
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
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Principal Investigator: Wade Gofton, MD, FRCSC The Ottawa Hospital Research Institute

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Responsible Party: Wade Gofton, Orthopaedic Surgeon, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03240484     History of Changes
Other Study ID Numbers: 20170312
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No