Spinal FusionNCT03240484
Examining Effects of Spinal Fusion on Outcomes Following Total Hip Replacement
An observational study of Spinal Fusion and Total Hip Replacement, run by Ottawa Hospital Research Institute at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Fusion, Total Hip Replacement
- What is being tested?
- X-Ray Imaging and Gait Analysis
- How many people
- 160 participants
- Where
- 1 siteCanada
- Study dates
- 15 May 2017to 1 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Patient does not meet all 'inclusion' criteria
- Patient is unable to answer questionnaires
- Unable to get x-rays for other medical reasons
- Severe dementia
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Ottawa Hospital Research Institute
Ottawa, Ontario, K1Y4E9
Research Manager, 613-737-8920
Wade Gofton, MD FRCSC MEd
About this study
Official title: 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.
Read the 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.
- Conditions
- Spinal Fusion, Total Hip Replacement
- Being tested
- X-Ray Imaging, Gait Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X-Ray ImagingDiagnostic test
X-Ray imaging in the following positions: Lateral standing, lateral seated, standard standing AP pelvis and AP pelvis lying down.
Gait AnalysisOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: X-Ray Imaging; Other: Gait Analysis | |
| 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. Receives: Diagnostic Test: X-Ray Imaging; Other: Gait Analysis | |
| 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. Receives: Diagnostic Test: X-Ray Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant positioning
Radiographic assessment (x-ray cup orientation measurements)
Measured: 6months or greater post-operative
Secondary outcomes (4)
Hip dysfunction and osteoarthritis outcome score (HOOS)
Disease-specific quality of life measure
Measured: 6months or greater post-operative
Oxford Hip Score
Disease-specific quality of life measure
Measured: 6months or greater post-operative
SF-12 Questionnaire
Patient-reported overall quality of life measure
Measured: 6months or greater post-operative
Oswestry low back disability questionnaire
Assessment of low back pain
Measured: 6months or greater post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start15 May 2017
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal FusionStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wade Gofton, Ottawa Hospital Research Institute
- Investigators
- Wade Gofton, MD, FRCSC, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240484
- Sponsor's protocol ID
- 20170312
- Status last verified
- Mar 2020
- First submitted
- 21 Jul 2017
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Effects of Spinal Arthrodesis on Outcomes Following Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT03240484
- Acronym / sponsor ID
- 20170312
- Conditions
- Spinal Fusion, Total Hip Replacement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 7 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Spine Fusion and Total Hip Replacement | – | Diagnostic Test: X-Ray Imaging, Other: Gait AnalysisAny 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 | – | Diagnostic Test: X-Ray Imaging, Other: Gait AnalysisAny 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. |
| Spine Fusion Only Group | – | Diagnostic Test: X-Ray ImagingAny patient who has had spine fusion only (no hip replacement surgery). Patients will undergo x-ray imaging and complete functional assessment questionnaires. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- Patient does not meet all 'inclusion' criteria
- Patient is unable to answer questionnaires
- Unable to get x-rays for other medical reasons
- Severe dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| X-Ray ImagingX-Ray imaging in the following positions: Lateral standing, lateral seated, standard standing AP pelvis and AP pelvis lying down. | Diagnostic test | Spine Fusion Only Group, Spine Fusion and Total Hip Replacement, Total Hip Replacement Group |
| Gait AnalysisCertain 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. | Other | Spine Fusion and Total Hip Replacement, Total Hip Replacement Group |
Primary outcome
Implant positioning
Time frame: 6months or greater post-operative
Radiographic assessment (x-ray cup orientation measurements)
4 secondary outcomes
Hip dysfunction and osteoarthritis outcome score (HOOS)
Time frame: 6months or greater post-operative
Oxford Hip Score
Time frame: 6months or greater post-operative
SF-12 Questionnaire
Time frame: 6months or greater post-operative
Oswestry low back disability questionnaire
Time frame: 6months or greater post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wade Gofton, MD, FRCSC principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Fusion and Total Hip Replacement, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meaghan Dufresne (613-737-8899, meadufresne@ohri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant positioning (time frame: 6months or greater post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020.