OsteoarthritisNCT00664508
Mobility Assessment of Patients With Total Hip Arthroplasty
A study testing Motion analysis in people with Osteoarthritis and Arthroplasty, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
The purpose of this study is to describe the 3D joint biomechanics of the lower extremities of patients having had a total hip replacement or hip resurfacing surgery as compared to a healthy age and weight matched control group during level walking, stair ascent and descent, and entering and exiting the front seat of… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Arthroplasty, Hip Replacement
- What is being tested?
- Motion analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2007to 28 Apr 2024
- Phase
- Interventional
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 15 patients between the ages of 50 and 75 yrs having undergone a primary total hip replacement or hip resurfacing within 6 to 18 months of the study will participate, as well as an equal number of age, sex, height and weight matched healthy control participants.
Who cannot join
- Potential participants for the control group will be asked if they have had previous lower limb ailments or surgery, and if they have they will be excluded. Moreover, the THR participants cannot have had secondary hip replacement due to infection, revision surgery, or a concomitant surgical procedure (i.e., graft). Participants from both groups cannot have had any medical conditions which could affect physical movement such as a stroke.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mobility Assessment of Patients With Total Hip Arthroplasty: Joint Mechanics and Rehabilitation
The purpose of this study is to describe the 3D joint biomechanics of the lower extremities of patients having had a total hip replacement or hip resurfacing surgery as compared to a healthy age and weight matched control group during level walking, stair ascent and descent, and entering and exiting the front seat of a car.
Read the detailed description
Much research has shown that patients are generally satisfied with pain relief in the months and years following a total hip replacement (THR) or hip resurfacing procedure. However, many express dissatisfaction with their ability to perform daily activities, a reduced walking ability and long-term lower extremity muscle weakness. Given the general lack of knowledge surrounding joint motion of the lower extremities in the THR population, there is a need to characterize the joint mechanics of people having undergone THR, so that interventions and rehabilitation strategies can be designed to reduce post-operative complications and improve mobility.
- Conditions
- Osteoarthritis, Arthroplasty, Hip Replacement
- Being tested
- Motion analysis
- Keywords
- Arthroplasty, Hip Replacement, motion analysis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motion analysisProcedure or surgery
Motion analysis will be administered to each of the three groups: Lateral approach, anterior approach and posterior approach
| Study group | Role | What they receive |
|---|---|---|
| Lateral approach | Active comparator | Lateral approach Intervention: Motion Analysis. Standard AP/Lateral x-rays of the hips, functional assessment questionnaires and 3D joint mechanic assessment at the Biomechanics Laboratory Receives: Procedure: Motion analysis |
| Anterior approach | Active comparator | Anterior approach Intervention: Motion Analysis. Standard AP/Lateral x-rays of the hips, functional assessment questionnaires and 3D joint mechanic assessment at the Biomechanics Laboratory Receives: Procedure: Motion analysis |
| Posterior approach | Active comparator | Posterior approach Intervention: Motion Analysis. Standard AP/Lateral x-rays of the hips, functional assessment questionnaires and 3D joint mechanic assessment at the Biomechanics Laboratory Receives: Procedure: Motion analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint mechanics of people having undergone total hip replacement
3D joint mechanics of the lower extremities during level walking, stair ascent and descent, and entering and exiting the front seat of the car
Measured: 6-18 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2008 (estimated)
- Study startNov 2007
- Primary completion28 Apr 2024 (estimated)
- Study completion28 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Comparative study with a control group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Paul E Beaule, MD, FRCSC, Principal investigator, University of Ottawa / The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00664508
- Sponsor's protocol ID
- 2007-390
- Status last verified
- Jan 2024
- First submitted
- 21 Apr 2008
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobility Assessment of Patients With Total Hip Arthroplasty: Joint Mechanics and Rehabilitation
- ClinicalTrials.gov ID
- NCT00664508
- Acronym / sponsor ID
- 2007-390
- Conditions
- Osteoarthritis, Arthroplasty, Hip Replacement
- Keywords
- Arthroplasty, Hip Replacement, motion analysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Nov 2007 (actual)
- Primary completion
- 28 Apr 2024 (estimated)
- Study completion
- 28 Apr 2024 (estimated)
- First posted
- 23 Apr 2008 (estimated)
- 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 this study is to describe the 3D joint biomechanics of the lower extremities of patients having had a total hip replacement or hip resurfacing surgery as compared to a healthy age and weight matched control group during level walking, stair ascent and descent, and entering and exiting the front seat of a car.
Detailed description
Much research has shown that patients are generally satisfied with pain relief in the months and years following a total hip replacement (THR) or hip resurfacing procedure. However, many express dissatisfaction with their ability to perform daily activities, a reduced walking ability and long-term lower extremity muscle weakness. Given the general lack of knowledge surrounding joint motion of the lower extremities in the THR population, there is a need to characterize the joint mechanics of people having undergone THR, so that interventions and rehabilitation strategies can be designed to reduce post-operative complications and improve mobility.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Comparative study with a control group
| Arm | Type | Receives |
|---|---|---|
| Lateral approach | Active comparator | Procedure: Motion analysisLateral approach Intervention: Motion Analysis. Standard AP/Lateral x-rays of the hips, functional assessment questionnaires and 3D joint mechanic assessment at the Biomechanics Laboratory |
| Anterior approach | Active comparator | Procedure: Motion analysisAnterior approach Intervention: Motion Analysis. Standard AP/Lateral x-rays of the hips, functional assessment questionnaires and 3D joint mechanic assessment at the Biomechanics Laboratory |
| Posterior approach | Active comparator | Procedure: Motion analysisPosterior approach Intervention: Motion Analysis. Standard AP/Lateral x-rays of the hips, functional assessment questionnaires and 3D joint mechanic assessment at the Biomechanics Laboratory |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 15 patients between the ages of 50 and 75 yrs having undergone a primary total hip replacement or hip resurfacing within 6 to 18 months of the study will participate, as well as an equal number of age, sex, height and weight matched healthy control participants.
Key exclusion criteria (1 listed)
- Potential participants for the control group will be asked if they have had previous lower limb ailments or surgery, and if they have they will be excluded. Moreover, the THR participants cannot have had secondary hip replacement due to infection, revision surgery, or a concomitant surgical procedure (i.e., graft). Participants from both groups cannot have had any medical conditions which could affect physical movement such as a stroke.
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 |
|---|---|---|
| Motion analysisMotion analysis will be administered to each of the three groups: Lateral approach, anterior approach and posterior approach | Procedure or surgery | Anterior approach, Lateral approach, Posterior approach |
Primary outcome
Joint mechanics of people having undergone total hip replacement
Time frame: 6-18 months post surgery
3D joint mechanics of the lower extremities during level walking, stair ascent and descent, and entering and exiting the front seat of the car
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
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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.
Paul E Beaule, MD, FRCSC principal investigator
University of Ottawa / The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motion analysis in people with Osteoarthritis and Arthroplasty, 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 1 inclusion and 1 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 5 Jan 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Joint mechanics of people having undergone total hip replacement (time frame: 6-18 months post surgery). 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 5 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.