Study 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.
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
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 26, 2016
CompletedFirst Posted
Study publicly available on registry
October 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 16, 2018
CompletedAugust 17, 2018
August 1, 2018
6 months
September 26, 2016
August 16, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Anterior-posterior translation of the femoral component with respect to the tibia component
Group mean in millimeters (mm)
at least one year post surgery
Axial rotation of the femoral component with respect to the tibia component
Group mean in degrees (°)
at least one year post surgery
Secondary Outcomes (4)
Traveled distance of center of pressure
at least one year post surgery
Velocity of center of pressure
at least one year post surgery
Rambling-trembling distance
at least one year post surgery
Isometric quadriceps muscle strength
at least one year post surgery
Study Arms (2)
Total knee arthroplasty with Vanguard XP
ACTIVE COMPARATORThe 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 with Vanguard CR
ACTIVE COMPARATORTotal knee arthroplasty system without preservation of the anterior cruciate ligament
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept. of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre
Hvidovre, 2650, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, MD, PhD, dr.med
Study Record Dates
First Submitted
September 26, 2016
First Posted
October 3, 2016
Study Start
September 1, 2016
Primary Completion
March 1, 2017
Study Completion
August 16, 2018
Last Updated
August 17, 2018
Record last verified: 2018-08