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Completed

NCT Number: NCT02002624

Patient-Specific Versus Conventional Instrumentation in TKA

The aim of this prospective multicenter randomized clinical trial (RCT) is to compare the clinical and radiologic results of primary total knee arthroplasty (TKA) using patient-specific versus conventional instrumentation.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with primary or secondary osteoarthritis of the knee requiring total knee arthroplasty
  • aged between 18 and 85 years
  • able to understand information
  • affiliated to social security.

Exclusion criteria

  • active or suspected sepsis
  • tumor around the knee
  • previous partial or total knee replacement
  • presence of hardware that could artifact MRI
  • contraindication to MRI
  • extra-articular deformation requiring osteotomy around the knee in conjunction with TKA
  • social situation that could impair follow-up.

Treatment and study plan

PSI

Device

Other names: Patient specific instrumentation

Conventional instrumentation

Device

Primary outcomes

  1. Mechanical axis

    Time frame: 3 months

    Lower limb mechanical axis was measured on a bipodal standing leg-length anteroposterior radiograph with the patella oriented straight made three months postoperatively, using Roman software version 1.70 (Oswestry, United Kingdom). Postoperative lower limb mechanical axis was calculated from the HKA (hip-knee-ankle) angle between the femoral and tibial mechanical axes, respectively. An HKA angle greater than 180° was indicative of valgus, whereas values lower than 180° indicated varus.

Secondary outcomes

  1. Components position

    Time frame: 3 months

    Also, components position in the coronal plane was measured on both the tibial and femoral sides by the femoral (F) angle between the tangent line of the distal prosthetic condyles and the mechanical axis of the femur, and by the tibial (T) angle between the tangent line of the prosthetic tibial baseplate and the mechanical axis of the tibia. In addition in the sagittal plane, tibial slope (TS) was measured by the angle between the tangent of the tibial baseplate and the posterior cortex of the tibia on a lateral view of the knee made at three-month follow-up.

Other outcomes

  1. Blood loss

    Time frame: 5 days

    According to Mercuriali et al.

Sponsors and collaborators

Lead sponsor

Cochin Hospital

Ambig

Registry information

Official study title

RCT Multicenter Comparison of Patient-Specific Versus Conventional Instrumentation in Primary TKA

Acronym: Visio

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 6, 2013
Registry last updated
Dec 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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