Kinematic Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties

August 16, 2018 updated by: Anders Troelsen, Hvidovre University Hospital

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

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hvidovre, Denmark, 2650
        • Dept. of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Device: Total knee arthroplasty with Vanguard XP
Device: Total knee arthroplasty with Vanguard CR
Active Comparator: Total knee arthroplasty with Vanguard CR
Total knee arthroplasty system without preservation of the anterior cruciate ligament
Device: Total knee arthroplasty with Vanguard XP
Device: Total knee arthroplasty with Vanguard CR

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
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

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Actual)

August 16, 2018

Study Registration Dates

First Submitted

September 26, 2016

First Submitted That Met QC Criteria

September 29, 2016

First Posted (Estimate)

October 3, 2016

Study Record Updates

Last Update Posted (Actual)

August 17, 2018

Last Update Submitted That Met QC Criteria

August 16, 2018

Last Verified

August 1, 2018

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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