OsteoarthritisPhase 1NCT00175461
Comparison of Two Minimally Invasive Surgical Techniques for Hip Replacement
A Phase 1 study testing hip surgery in people with Osteoarthritis, run by University of British Columbia at 1 site in Canada.
Trial summary
Comparison of the clinical effectiveness and cost-effectiveness of the MIS anterolateral approach (MIS Watson Jones, G3) versus anterolateral mini or posterolateral mini approaches in primary total hip arthroplasty Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- hip surgery
- Type of treatment
- Surgery or procedure
- How many people
- 156 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2005to 31 Aug 2011
- Phase
- Phase 1
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- No contralateral hip symptoms, no major comorbidity
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Clinical Effectiveness and Cost-effectiveness of the MIS Anterolateral Approach (MIS Watson Jones, G3) Versus Anterolateral Mini or Posterolateral Mini Approaches in Primary Total Hip Arthroplasty
Comparison of the clinical effectiveness and cost-effectiveness of the MIS anterolateral approach (MIS Watson Jones, G3) versus anterolateral mini or posterolateral mini approaches in primary total hip arthroplasty
- Conditions
- Osteoarthritis
- Being tested
- hip surgery
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hip surgeryProcedure or surgery
Comparison of the clinical effectiveness and cost-effectiveness of the MIS anterolateral approach (MIS Watson Jones, G3) versus anterolateral mini or posterolateral mini approaches in primary total hip arthroplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
3-months WOMAC score
Measured: 3 months
Secondary outcomes (1)
Cost-effectiveness at 2-years
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionApr 2009
- Study completion31 Aug 2011
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 University of British ColumbiaThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nelson Greidanus, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00175461
- Sponsor's protocol ID
- H04-70070
- Status last verified
- Mar 2017
- First submitted
- 11 Sep 2005
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Clinical Effectiveness and Cost-effectiveness of the MIS Anterolateral Approach (MIS Watson Jones, G3) Versus Anterolateral Mini or Posterolateral Mini Approaches in Primary Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT00175461
- Acronym / sponsor ID
- H04-70070
- Conditions
- Osteoarthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Apr 2009 (actual)
- Study completion
- 31 Aug 2011 (actual)
- First posted
- 15 Sep 2005 (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.
Comparison of the clinical effectiveness and cost-effectiveness of the MIS anterolateral approach (MIS Watson Jones, G3) versus anterolateral mini or posterolateral mini approaches in primary total hip arthroplasty
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- No contralateral hip symptoms, no major comorbidity
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| hip surgeryComparison of the clinical effectiveness and cost-effectiveness of the MIS anterolateral approach (MIS Watson Jones, G3) versus anterolateral mini or posterolateral mini approaches in primary total hip arthroplasty | Procedure or surgery | – |
Primary outcome
3-months WOMAC score
Time frame: 3 months
1 secondary outcome
Cost-effectiveness at 2-years
Time frame: Two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
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.
Nelson Greidanus, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing hip surgery in people with Osteoarthritis, run by University of British Columbia 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: finished, as of the sponsor's last update on 3 Mar 2017. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
3-months WOMAC score (time frame: 3 months). 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 3 Mar 2017.