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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03240484
Other study ID # 20170312
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 15, 2017
Est. completion date June 1, 2021

Study information

Verified date March 2020
Source Ottawa Hospital Research Institute
Contact Meaghan Dufresne
Phone 613-737-8899
Email meadufresne@ohri.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date June 1, 2021
Est. primary completion date November 1, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


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.

Locations

Country Name City State
Canada Ottawa Hospital Research Institute Ottawa Ontario

Sponsors (1)

Lead Sponsor Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Implant positioning Radiographic assessment (x-ray cup orientation measurements) 6months or greater post-operative
Secondary Hip dysfunction and osteoarthritis outcome score (HOOS) Disease-specific quality of life measure 6months or greater post-operative
Secondary Oxford Hip Score Disease-specific quality of life measure 6months or greater post-operative
Secondary SF-12 Questionnaire Patient-reported overall quality of life measure 6months or greater post-operative
Secondary Oswestry low back disability questionnaire Assessment of low back pain 6months or greater post-operative
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