- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00405470
A Prospective Randomized Trial Using Roentgen Stereophotogrammetric Analysis of the Advance Medial Pivot Knee
August 11, 2010 updated by: Dalhousie University
The purpose of this study is to determine whether this particular knee replacement is better than those already on the market.
By participation, it will further refine the design of future total knee replacements and perhaps increase longevity.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Joint arthroplasty is an effective surgical intervention, however prosthetic survivorship is finite.
New or modified prosthetic components are routinely introduced, partly in an effort to improve survivorship.
When new technologies emerge for total knee replacement it is not always evident that they are an improvement over existing options.
This determination requires long-term follow-up studies.
Conventional studies require a large number of patients and approximately 10 years of follow-up.
By using RSA to measure micromotion of prostheses over time problems can be elucidated with a much smaller sample over a shorter time period.
RSA involves using tantalum markers (0.5-1.0 mm beads inserted in the bone and prosthesis during surgery) to measure motion in subsequent bi-planar x-rays of the joint.
The relatively new Medial Pivot Knee (ADVANCE Knee) theoretically reproduces the natural kinematics of the knee but it is unclear what effect this design may have on the forces applied to the tibial component-bone interface.
The amount of micromotion of the tibial component is directly related to the amount of force exerted on it and inversely related to its fixation.
In this study we propose to compare in vivo micromotion at the tibial component-bone interface with the ADVANCE Medial-Pivot Knee (experimental group) versus a more conventional prosthesis (control), the ADVANCE Traditional Knee.
Patients (n=60; age 45-80 years old) with primary osteoarthritis of the knee and mono-articular disease will be randomized to receive either the ADVANCE Traditional or ADVANCE Medial-Pivot Knee using Simplex cement.
Eight tantalum markers will be placed in both the tibia and femur proximal to the prosthesis and in the polyethylene tray of the tibial component.
Pre-operatively and at 6, 12 and 24 months all patients will complete general health (SF-12) and joint specific questionnaires (Oxford -12 Item Knee Score), have their body mass index calculated, and have the range of motion, alignment, extensor function and ligamentous competency of their index knee recorded.
On the first weight-bearing day after surgery bi-planar standing x-rays will be taken and used as a reference point for tibial component position.
At 6, 12 and 24 months post-operatively patients will undergo more bi-planar standing x-rays incorporating provocative loading tests.
Micromotion will be analyzed through serial comparison of digital x-rays by blinded study personnel using RSA software.
Parametric statistics (unpaired Student's t-test) will be used to compare the 2 groups.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Primary osteoarthritis of the knee
- Mono-articular disease (Charnley Modified Type A)
Exclusion Criteria:
- Significant co-morbidity affecting ability to ambulate
- Flexion contracture greater than 15°
- Tibial subluxation greater than 10 mm on standing AP radiograph
- Greater than 10° of varus or 15° of valgus
- Extension lag greater than 10°
- Lateral or medial collateral ligament instability (> 10° varus/valgus)
- Previous osteotomy about the knee
- Previous arthroplasty of the knee
- Previous patellectomy
- Leg length discrepancy greater than 10 mm
- Morbid obesity (obesity that results in significant systemic problems)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Medial Pivot
|
medial pivot total knee arthroplasty tibial component vs standard posterior stabilized tibial component with post.
Medial pivot provides a constrained medial condyle through shape of polyethylene and reduces amount of bone removal on femoral side that would otherwise be removed to accommodate PS post
|
Active Comparator: Posterior Stabilized
|
medial pivot total knee arthroplasty tibial component vs standard posterior stabilized tibial component with post.
Medial pivot provides a constrained medial condyle through shape of polyethylene and reduces amount of bone removal on femoral side that would otherwise be removed to accommodate PS post
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
tibial implant micromotion relative to tibia at 2 years
Time Frame: 2 years postoperative
|
2 years postoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael Gross, MD FRCSC PhD, Dalhousie University & Capital District Health Authority
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2001
Primary Completion (Actual)
June 1, 2005
Study Completion (Actual)
June 1, 2006
Study Registration Dates
First Submitted
November 28, 2006
First Submitted That Met QC Criteria
November 28, 2006
First Posted (Estimate)
November 30, 2006
Study Record Updates
Last Update Posted (Estimate)
August 12, 2010
Last Update Submitted That Met QC Criteria
August 11, 2010
Last Verified
August 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DAL06-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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