Back to resultsKinematic Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties
Primary Purpose
Osteoarthritis
Status
Withdrawn
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Total knee arthroplasty with Vanguard XP
Total knee arthroplasty with Vanguard CR
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Participant in the XP vs. CR study (inherited traits from study inclusion)
- Overall healthy. Have attended standard physiotherapy after unilateral total knee replacement
- Are able to perform the tasks
- Excellent clinical scores (Oxford Knee Score above 39 at 1 year follow up)
Exclusion Criteria:
- Knee pain above 20 on a 0-100 visual analogue scale
- Any clinical relevant pain from adjacent joints
- Active Knee flexion below 100
- Signs of implant migration, loosening, and implant mal-alignment
Sites / Locations
- Dept. of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Total knee arthroplasty with Vanguard XP
Total knee arthroplasty with Vanguard CR
Arm Description
The new Vanguard XP Total knee arthroplasty system is a further development of the Vanguard TKA. The new Vanguard XP system both cruciate ligaments are preserved.
Total knee arthroplasty system without preservation of the anterior cruciate ligament
Outcomes
Primary Outcome Measures
Anterior-posterior translation of the femoral component with respect to the tibia component
Group mean in millimeters (mm)
Axial rotation of the femoral component with respect to the tibia component
Group mean in degrees (°)
Secondary Outcome Measures
Traveled distance of center of pressure
Group mean in centimeters (cm)
Velocity of center of pressure
Group mean in mm/second
Rambling-trembling distance
Group mean in mm
Isometric quadriceps muscle strength
Group mean in newton meter pr. kilograms weight (Nm/kg)
Full Information
NCT ID
NCT02921594
First Posted
September 26, 2016
Last Updated
August 16, 2018
Sponsor
Hvidovre University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02921594
Brief Title
Kinematic Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties
Official Title
Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties: A Cross Sectional Pilot Study Evaluating Intraarticular Kinematics and Standing Balance by Dynamic Fluoroscopy and Force Plate Examination
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Withdrawn
Why Stopped
NCT02921594 was not a RCT but a secondary pilot study designed to establish a fluoroscopic test-set up on 10 selected patients from another RCT.
Study Start Date
September 2016 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
August 16, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
4. Oversight
5. Study Description
Brief Summary
Primary: The primary objective of this pilot study is to compare the intraarticular kinematics by fluoroscopy of Vanguard XP to that of Vanguard CR.
Secondary: The secondary objective of this pilot study is to compare the standing balance by force plate of patients with the Vanguard XP prosthesis to those who have Vanguard CR prosthesis. Furthermore, we wish to assess isometric quadriceps muscle strength in both groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Total knee arthroplasty with Vanguard XP
Arm Type
Active Comparator
Arm Description
The new Vanguard XP Total knee arthroplasty system is a further development of the Vanguard TKA. The new Vanguard XP system both cruciate ligaments are preserved.
Arm Title
Total knee arthroplasty with Vanguard CR
Arm Type
Active Comparator
Arm Description
Total knee arthroplasty system without preservation of the anterior cruciate ligament
Intervention Type
Device
Intervention Name(s)
Total knee arthroplasty with Vanguard XP
Intervention Type
Device
Intervention Name(s)
Total knee arthroplasty with Vanguard CR
Primary Outcome Measure Information:
Title
Anterior-posterior translation of the femoral component with respect to the tibia component
Description
Group mean in millimeters (mm)
Time Frame
at least one year post surgery
Title
Axial rotation of the femoral component with respect to the tibia component
Description
Group mean in degrees (°)
Time Frame
at least one year post surgery
Secondary Outcome Measure Information:
Title
Traveled distance of center of pressure
Description
Group mean in centimeters (cm)
Time Frame
at least one year post surgery
Title
Velocity of center of pressure
Description
Group mean in mm/second
Time Frame
at least one year post surgery
Title
Rambling-trembling distance
Description
Group mean in mm
Time Frame
at least one year post surgery
Title
Isometric quadriceps muscle strength
Description
Group mean in newton meter pr. kilograms weight (Nm/kg)
Time Frame
at least one year post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participant in the XP vs. CR study (inherited traits from study inclusion)
Overall healthy. Have attended standard physiotherapy after unilateral total knee replacement
Are able to perform the tasks
Excellent clinical scores (Oxford Knee Score above 39 at 1 year follow up)
Exclusion Criteria:
Knee pain above 20 on a 0-100 visual analogue scale
Any clinical relevant pain from adjacent joints
Active Knee flexion below 100
Signs of implant migration, loosening, and implant mal-alignment
Facility Information:
Facility Name
Dept. of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Kinematic Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties
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