A Prospective Randomized Trial Using Roentgen Stereophotogrammetric Analysis of the Advance Medial Pivot Knee
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Advance Medial Pivot Knee Arthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring arthroplasty, RSA, micromotion, osteoarthritis
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Medial Pivot
Posterior Stabilized
Arm Description
Outcomes
Primary Outcome Measures
tibial implant micromotion relative to tibia at 2 years
Secondary Outcome Measures
Full Information
NCT ID
NCT00405470
First Posted
November 28, 2006
Last Updated
August 11, 2010
Sponsor
Dalhousie University
Collaborators
Stryker Trauma GmbH
1. Study Identification
Unique Protocol Identification Number
NCT00405470
Brief Title
A Prospective Randomized Trial Using Roentgen Stereophotogrammetric Analysis of the Advance Medial Pivot Knee
Official Title
A Prospective Randomized Trial Using Roentgen Stereophotogrammetric Analysis of the Advance Medial Pivot Knee
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
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 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
arthroplasty, RSA, micromotion, osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Medial Pivot
Arm Type
Active Comparator
Arm Title
Posterior Stabilized
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Advance Medial Pivot Knee Arthroplasty
Intervention Description
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
Primary Outcome Measure Information:
Title
tibial implant micromotion relative to tibia at 2 years
Time Frame
2 years postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Gross, MD FRCSC PhD
Organizational Affiliation
Dalhousie University & Capital District Health Authority
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
A Prospective Randomized Trial Using Roentgen Stereophotogrammetric Analysis of the Advance Medial Pivot Knee
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