AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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.

Canada1 site
  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 3A7

Other trials in Canada

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 groups in NCT00405483
Study groupRoleWhat they receive
Minimally invasive exposureActive comparatorSurgical technique, minimal incision
Receives: Procedure: Minimally Invasive
Standard exposureActive comparatorStandard Incision
Receives: Procedure: Standard exposure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted30 Nov 2006 (estimated)
  2. Study startOct 2005
  3. Primary completionDec 2014
  4. Study completionDec 2019 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in