Kinematic Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02921594
• Other study ID #: XPvsCR_Fluoroscopi_v.1.0
• Status: Withdrawn
• Phase: N/A
• Start date: September 2016
• Est. completion date: August 16, 2018

Study information

• Verified date: August 2018
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 16, 2018
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Device:
• Total knee arthroplasty with Vanguard XP

• Total knee arthroplasty with Vanguard CR

Locations

Country	Name	City	State
Denmark	Dept. of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anterior-posterior translation of the femoral component with respect to the tibia component	Group mean in millimeters (mm)	at least one year post surgery
Primary	Axial rotation of the femoral component with respect to the tibia component	Group mean in degrees (°)	at least one year post surgery
Secondary	Traveled distance of center of pressure	Group mean in centimeters (cm)	at least one year post surgery
Secondary	Velocity of center of pressure	Group mean in mm/second	at least one year post surgery
Secondary	Rambling-trembling distance	Group mean in mm	at least one year post surgery
Secondary	Isometric quadriceps muscle strength	Group mean in newton meter pr. kilograms weight (Nm/kg)	at least one year post surgery