RSA for a Comparison of MIS vs. Standard Exposure in Total Hip Arthroplasty
Primary Purpose
Osteoarthritis
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Standard exposure
Minimally Invasive
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring arthroplasty, RSA, micromotion, osteoarthritis, minimally invasive, ProfemurZ
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Sites / Locations
- QEII Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Minimally invasive exposure
Standard exposure
Arm Description
Surgical technique, minimal incision
Standard Incision
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00405483
First Posted
November 28, 2006
Last Updated
February 7, 2019
Sponsor
Dalhousie University
Collaborators
Stryker Trauma GmbH
1. Study Identification
Unique Protocol Identification Number
NCT00405483
Brief Title
RSA for a Comparison of MIS vs. Standard Exposure in Total Hip Arthroplasty
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 2005 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dalhousie University
Collaborators
Stryker Trauma GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
arthroplasty, RSA, micromotion, osteoarthritis, minimally invasive, ProfemurZ
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Minimally invasive exposure
Arm Type
Active Comparator
Arm Description
Surgical technique, minimal incision
Arm Title
Standard exposure
Arm Type
Active Comparator
Arm Description
Standard Incision
Intervention Type
Procedure
Intervention Name(s)
Standard exposure
Other Intervention Name(s)
Surgical technique, standard exposure in hip arthroplasty
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Minimally Invasive
Intervention Description
Minimally invasive surgical technique (minimal incision)
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Gross, MD FRCSC
Organizational Affiliation
Dalhousie University & Capital District Health Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
QEII Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
RSA for a Comparison of MIS vs. Standard Exposure in Total Hip Arthroplasty
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