Examining Effects of Spinal Fusion on Outcomes Following Total Hip Replacement

• Conditions: Total Hip Replacement; Spinal Fusion
• Interventions: Diagnostic Test: X-Ray Imaging; Other: Gait Analysis

• Registration Number: NCT03240484
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-05-15
• Study First Submitted: 2017-07-21
• Study First Submitted QC: 2017-08-01
• Study First Posted: 2017-08-07
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-26
• Last Update Posted: 2020-03-30
• Primary Completion: 2020-11-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Spine Fusion Only Group	X-Ray Imaging	Any patient who has had spine fusion only (no hip replacement surgery). Patients will undergo x-ray imaging and complete functional assessment questionnaires.
Spine Fusion and Total Hip Replacement	X-Ray Imaging	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.
Spine Fusion and Total Hip Replacement	Gait Analysis	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.
Total Hip Replacement Group	X-Ray Imaging	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.
Total Hip Replacement Group	Gait Analysis	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.

Primary Outcome Measures

Name	Time	Method
Implant positioning	6months or greater post-operative	Radiographic assessment (x-ray cup orientation measurements)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ottawa Hospital Research Institute; 🇨🇦 Ottawa, Ontario, Canada