Examining Effects of Spinal Fusion on Outcomes Following Total Hip Replacement

NCT ID: NCT03240484

Last Updated: 2020-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-15

Study Completion Date

2021-06-01

Brief Summary

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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

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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.

Conditions

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Spinal Fusion Total Hip Replacement

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

X-Ray Imaging

Intervention Type DIAGNOSTIC_TEST

X-Ray imaging in the following positions: Lateral standing, lateral seated, standard standing AP pelvis and AP pelvis lying down.

Gait Analysis

Intervention Type OTHER

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.

X-Ray Imaging

Intervention Type DIAGNOSTIC_TEST

X-Ray imaging in the following positions: Lateral standing, lateral seated, standard standing AP pelvis and AP pelvis lying down.

Gait Analysis

Intervention Type OTHER

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.

X-Ray Imaging

Intervention Type DIAGNOSTIC_TEST

X-Ray imaging in the following positions: Lateral standing, lateral seated, standard standing AP pelvis and AP pelvis lying down.

Interventions

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X-Ray Imaging

X-Ray imaging in the following positions: Lateral standing, lateral seated, standard standing AP pelvis and AP pelvis lying down.

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ottawa Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Wade Gofton

Orthopaedic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wade Gofton, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital Research Institute

Locations

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Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Meaghan Dufresne

Role: CONTACT

613-737-8899

Research Manager

Role: CONTACT

613-737-8920

Facility Contacts

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Research Manager

Role: primary

613-737-8920

Other Identifiers

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20170312

Identifier Type: -

Identifier Source: org_study_id

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