Kinematic Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties

Not Applicable

Withdrawn

• Conditions: Osteoarthritis
• Interventions: Device: Total knee arthroplasty with Vanguard XP; Device: Total knee arthroplasty with Vanguard CR

• Registration Number: NCT02921594
• Lead Sponsor: Hvidovre University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-26
• Study First Submitted QC: 2016-09-29
• Study First Posted: 2016-10-03
• Primary Completion: 2017-03
• Status Verified: 2018-08
• Study Completion: 2018-08-16
• Last Update Submitted: 2018-08-16
• Last Update Posted: 2018-08-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Total knee arthroplasty with Vanguard CR	Total knee arthroplasty with Vanguard CR	Total knee arthroplasty system without preservation of the anterior cruciate ligament
Total knee arthroplasty with Vanguard XP	Total knee arthroplasty with Vanguard CR	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 with Vanguard CR	Total knee arthroplasty with Vanguard XP	Total knee arthroplasty system without preservation of the anterior cruciate ligament
Total knee arthroplasty with Vanguard XP	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.

Primary Outcome Measures

Name	Time	Method
Anterior-posterior translation of the femoral component with respect to the tibia component	at least one year post surgery	Group mean in millimeters (mm)
Axial rotation of the femoral component with respect to the tibia component	at least one year post surgery	Group mean in degrees (°)

Secondary Outcome Measures

Name	Time	Method
Velocity of center of pressure	at least one year post surgery	Group mean in mm/second
Isometric quadriceps muscle strength	at least one year post surgery	Group mean in newton meter pr. kilograms weight (Nm/kg)
Rambling-trembling distance	at least one year post surgery	Group mean in mm
Traveled distance of center of pressure	at least one year post surgery	Group mean in centimeters (cm)

Trial Locations

Locations (1)

Dept. of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre; 🇩🇰 Hvidovre, Denmark