OsteoarthritisNCT00405483
RSA for a Comparison of MIS vs. Standard Exposure in Total Hip Arthroplasty
A study testing Standard exposure and Minimally Invasive in people with Osteoarthritis, run by Dalhousie University at 1 site in Canada.
Trial summary
The purpose of this study is to determine if MIS for primary hip replacement surgery increases the risk of long term aseptic loosening as predicted by implant micromotion detected by radiostereometric analysis. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Standard exposure and Minimally Invasive
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2005to Dec 2019
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects are under the age of 65 years
- Subjects have not had hip replacement surgery on the affected hip
- Subjects have decided to undergo a primary total hip replacement of the affected hip
Who cannot join
- Having a previous hip infection
- Undergoing surgery for arthritis due to a previous injury, rheumatoid arthritis or hip dysplasia (a hip that did not develop completely)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Utilizing RSA for a Comparison of Minimally Invasive Surgery (MIS) vs. Standard Exposure in Primary Total Hip Arthroplasty With the ProfemurZ Modular Femoral Stem
The purpose of this study is to determine if MIS for primary hip replacement surgery increases the risk of long term aseptic loosening as predicted by implant micromotion detected by radiostereometric analysis.
Read the detailed description
Hip replacement is an effective option for treating chronic hip conditions that cause pain and functional impairment(1). Significant improvements in quality of life, as measured by both disease specific and generic quality of life measures, have been well documented (2-4).
Hip replacement implants are a 'ball in cup' design, and consist of two articulating components: a femoral head replacement which can consist of a ball attached to a stem that is inserted into the proximal femur, and an acetabular component, which can be made of different materials that are inserted into a liner of metal that is inserted into the pelvis. These components can be attached to the patient's bone using either polymethylmethacrylate - a polymer more commonly referred to as bone cement - or by roughening the surface of the implant to allow bone ingrowth. Hip replacements can therefore be broadly classified by the fixation technique used: cemented, uncemented, or hybrid, consisting of a cemented femoral component and an uncemented acetabular component. The uncemented design is very commonly used in younger patients because the quality of bone is better in the patient, the implants have demonstrated long term survival, and the cementing step is no longer necessary for achieving long term fixation.
The 10 year survival of current uncemented total hip designs approaches 95% (5). The majority of the 5% that are revised are done so for aseptic ("non-infected") loosening of the components. The functional results of revision total hip surgery are poorer than primary hip replacement surgery (3, 5, 6). There are approximately 20 000 hip replacement performed each year in Canada (CIHI website); this will result in roughly 1000 revisions over the next 10 years - a great expense, both in terms of health care resources and in patients' loss of function. Obviously, efforts directed at decreasing revision rates are clinically and financially worthwhile.
Implant failure due to aseptic loosening is thought to arise from both patient related factors such as age, sex and diagnosis, and from implant related factors such as design and materials used (5). Efforts at reducing aseptic loosening by changing implant design and cement formulation have occasionally resulted in products that perform well in the laboratory but fail miserably in real life, often after being implanted into large numbers of patients(7-10). This has led to a call for careful and controlled introduction of new implant designs using randomized trials and precise radiographic assessment techniques such as radiostereometric analysis (RSA) to look for early signs of loosening and impending failure (7, 9, 11).
Minimally Invasive Surgery (MIS) is a new technology in the optimization of healthcare services. It has been developed to minimize damage to surrounding tissue during arthroplasty. by reducing the size of the incision. The possible benefit is dramatic reductions in length of stay (LOS) for total hip replacement (THR) patients (12). However, MIS development has led to modifications to existing instrumentation, prostheses and technique which may impact long-term survival of the implant (13). There has been little research investigating the effects of these changes on long-term patient outcomes following MIS surgery. The use of RSA will allow for better understanding of the early fixation of the implant and the potential for early failure due to aseptic loosening.
- Conditions
- Osteoarthritis
- Being tested
- Standard exposure, Minimally Invasive
- Keywords
- arthroplasty, RSA, micromotion, osteoarthritis, minimally invasive, ProfemurZ
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard exposureProcedure or surgery
Also called Surgical technique, standard exposure in hip arthroplasty
Minimal invasive vs standard exposure of the joint is the difference between a small incision, smaller equipment for less tissue damage vs large incision (standard is greater than 10cm)and subsequent more tissue damage.
Minimally InvasiveProcedure or surgery
Minimally invasive surgical technique (minimal incision)
| Study group | Role | What they receive |
|---|---|---|
| Minimally invasive exposure | Active comparator | Surgical technique, minimal incision Receives: Procedure: Minimally Invasive |
| Standard exposure | Active comparator | Standard Incision Receives: Procedure: Standard exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
The purpose of this study is to determine if MIS for primary hip replacement surgery increases the risk of long term aseptic loosening as predicted by implant micromotion detected by radiostereometric analysis
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2006 (estimated)
- Study startOct 2005
- Primary completionDec 2014
- Study completionDec 2019 (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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dalhousie University
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Trauma and Extremities
- Responsible party
- Sponsor
- Investigators
- Michael Gross, MD FRCSC, Principal investigator, Dalhousie University & Capital District Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00405483
- Sponsor's protocol ID
- DAL06-03
- Status last verified
- Jan 2019
- First submitted
- 28 Nov 2006
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Utilizing RSA for a Comparison of Minimally Invasive Surgery (MIS) vs. Standard Exposure in Primary Total Hip Arthroplasty With the ProfemurZ Modular Femoral Stem
- ClinicalTrials.gov ID
- NCT00405483
- Acronym / sponsor ID
- DAL06-03
- Conditions
- Osteoarthritis
- Keywords
- arthroplasty, RSA, micromotion, osteoarthritis, minimally invasive, ProfemurZ
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dalhousie UniversityUniversity, hospital or other
- Collaborators
- Stryker Trauma and Extremities
- Study start
- Oct 2005
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2019 (estimated)
- First posted
- 30 Nov 2006 (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 determine if MIS for primary hip replacement surgery increases the risk of long term aseptic loosening as predicted by implant micromotion detected by radiostereometric analysis.
Detailed description
Hip replacement is an effective option for treating chronic hip conditions that cause pain and functional impairment(1). Significant improvements in quality of life, as measured by both disease specific and generic quality of life measures, have been well documented (2-4).
Hip replacement implants are a 'ball in cup' design, and consist of two articulating components: a femoral head replacement which can consist of a ball attached to a stem that is inserted into the proximal femur, and an acetabular component, which can be made of different materials that are inserted into a liner of metal that is inserted into the pelvis. These components can be attached to the patient's bone using either polymethylmethacrylate - a polymer more commonly referred to as bone cement - or by roughening the surface of the implant to allow bone ingrowth. Hip replacements can therefore be broadly classified by the fixation technique used: cemented, uncemented, or hybrid, consisting of a cemented femoral component and an uncemented acetabular component. The uncemented design is very commonly used in younger patients because the quality of bone is better in the patient, the implants have demonstrated long term survival, and the cementing step is no longer necessary for achieving long term fixation.
The 10 year survival of current uncemented total hip designs approaches 95% (5). The majority of the 5% that are revised are done so for aseptic ("non-infected") loosening of the components. The functional results of revision total hip surgery are poorer than primary hip replacement surgery (3, 5, 6). There are approximately 20 000 hip replacement performed each year in Canada (CIHI website); this will result in roughly 1000 revisions over the next 10 years - a great expense, both in terms of health care resources and in patients' loss of function. Obviously, efforts directed at decreasing revision rates are clinically and financially worthwhile.
Implant failure due to aseptic loosening is thought to arise from both patient related factors such as age, sex and diagnosis, and from implant related factors such as design and materials used (5). Efforts at reducing aseptic loosening by changing implant design and cement formulation have occasionally resulted in products that perform well in the laboratory but fail miserably in real life, often after being implanted into large numbers of patients(7-10). This has led to a call for careful and controlled introduction of new implant designs using randomized trials and precise radiographic assessment techniques such as radiostereometric analysis (RSA) to look for early signs of loosening and impending failure (7, 9, 11).
Minimally Invasive Surgery (MIS) is a new technology in the optimization of healthcare services. It has been developed to minimize damage to surrounding tissue during arthroplasty. by reducing the size of the incision. The possible benefit is dramatic reductions in length of stay (LOS) for total hip replacement (THR) patients (12). However, MIS development has led to modifications to existing instrumentation, prostheses and technique which may impact long-term survival of the implant (13). There has been little research investigating the effects of these changes on long-term patient outcomes following MIS surgery. The use of RSA will allow for better understanding of the early fixation of the implant and the potential for early failure due to aseptic loosening.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive exposure | Active comparator | Procedure: Minimally InvasiveSurgical technique, minimal incision |
| Standard exposure | Active comparator | Procedure: Standard exposureStandard Incision |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects are under the age of 65 years
- Subjects have not had hip replacement surgery on the affected hip
- Subjects have decided to undergo a primary total hip replacement of the affected hip
Key exclusion criteria (2 listed)
- Having a previous hip infection
- Undergoing surgery for arthritis due to a previous injury, rheumatoid arthritis or hip dysplasia (a hip that did not develop completely)
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 |
|---|---|---|
| Standard exposureAlso: Surgical technique, standard exposure in hip arthroplastyMinimal invasive vs standard exposure of the joint is the difference between a small incision, smaller equipment for less tissue damage vs large incision (standard is greater than 10cm)and subsequent more tissue damage. | Procedure or surgery | Standard exposure |
| Minimally InvasiveMinimally invasive surgical technique (minimal incision) | Procedure or surgery | Minimally invasive exposure |
Primary outcome
The purpose of this study is to determine if MIS for primary hip replacement surgery increases the risk of long term aseptic loosening as predicted by implant micromotion detected by radiostereometric analysis
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
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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.
Michael Gross, MD FRCSC principal investigator
Dalhousie University & Capital District Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard exposure and Minimally Invasive in people with Osteoarthritis, run by Dalhousie University 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 3 inclusion and 2 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 8 Feb 2019. 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?
The purpose of this study is to determine if MIS for primary hip replacement surgery increases the risk of long term aseptic loosening as predicted by implant micromotion detected by radiostereometric analysis (time frame: 2 years). 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 8 Feb 2019.