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Kinematic Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties

H

Hvidovre University Hospital

Status

Withdrawn

Conditions

Osteoarthritis

Treatments

Device: Total knee arthroplasty with Vanguard CR
Device: Total knee arthroplasty with Vanguard XP

Study type

Interventional

Funder types

Other

Identifiers

NCT02921594
XPvsCR_Fluoroscopi_v.1.0

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

0 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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