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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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02921594
Enrollment
0
Registered
2016-10-03
Start date
2016-09-30
Completion date
2018-08-16
Last updated
2018-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

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.

Interventions

DEVICETotal knee arthroplasty with Vanguard XP
DEVICETotal knee arthroplasty with Vanguard CR

Sponsors

Hvidovre University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Anterior-posterior translation of the femoral component with respect to the tibia componentat least one year post surgeryGroup mean in millimeters (mm)
Axial rotation of the femoral component with respect to the tibia componentat least one year post surgeryGroup mean in degrees (°)

Secondary

MeasureTime frameDescription
Traveled distance of center of pressureat least one year post surgeryGroup mean in centimeters (cm)
Velocity of center of pressureat least one year post surgeryGroup mean in mm/second
Rambling-trembling distanceat least one year post surgeryGroup mean in mm
Isometric quadriceps muscle strengthat least one year post surgeryGroup mean in newton meter pr. kilograms weight (Nm/kg)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026