- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02921594
Kinematic Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Hvidovre, Denmark, 2650
- Dept. of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
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: Total knee arthroplasty with Vanguard XP
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.
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Active Comparator: Total knee arthroplasty with Vanguard CR
Total knee arthroplasty system without preservation of the anterior cruciate ligament
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anterior-posterior translation of the femoral component with respect to the tibia component
Time Frame: at least one year post surgery
|
Group mean in millimeters (mm)
|
at least one year post surgery
|
Axial rotation of the femoral component with respect to the tibia component
Time Frame: at least one year post surgery
|
Group mean in degrees (°)
|
at least one year post surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Traveled distance of center of pressure
Time Frame: at least one year post surgery
|
Group mean in centimeters (cm)
|
at least one year post surgery
|
Velocity of center of pressure
Time Frame: at least one year post surgery
|
Group mean in mm/second
|
at least one year post surgery
|
Rambling-trembling distance
Time Frame: at least one year post surgery
|
Group mean in mm
|
at least one year post surgery
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Isometric quadriceps muscle strength
Time Frame: at least one year post surgery
|
Group mean in newton meter pr.
kilograms weight (Nm/kg)
|
at least one year post surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XPvsCR_Fluoroscopi_v.1.0
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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