Examining Effects of Spinal Fusion on Outcomes Following Total Hip Replacement

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.

Study Overview

• Status: Unknown
• Conditions: Spinal Fusion; Total Hip Replacement
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 160

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y4E9
      • Recruiting
      • Ottawa Hospital Research Institute
      • Contact: Research Manager; Phone Number: 613-737-8920
      • Principal Investigator: Wade Gofton, MD FRCSC MEd
      • Sub-Investigator: Paul Beaule, MD FRCSC
      • Sub-Investigator: George Grammatopoulos, BMBBS DPhil Oxon MRCS FRCS
      • Sub-Investigator: Matthew Coyle, MD
      • Sub-Investigator: Mario Lamontagne, PhD
      • Sub-Investigator: Philippe Phan, MD PhD FRCSC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant positioning	Radiographic assessment (x-ray cup orientation measurements)	6months or greater post-operative

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Investigators: Principal Investigator: Wade Gofton, MD, FRCSC, The Ottawa Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2017
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: July 21, 2017
• First Submitted That Met QC Criteria: August 1, 2017
• First Posted (Actual): August 7, 2017

Study Record Updates

• Last Update Posted (Actual): March 30, 2020
• Last Update Submitted That Met QC Criteria: March 26, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 20170312

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No