Examining Effects of Spinal Fusion on Outcomes Following Total Hip Replacement

Spinal Fusion Clinical Trial

Official title:

Examining Effects of Spinal Arthrodesis on Outcomes Following Total Hip Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03240484
• Other study ID #: 20170312
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• 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.

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