Patient-Specific Versus Conventional Instrumentation in TKA (Visio)

December 5, 2013 updated by: Moussa Hamadouche, Cochin Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

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

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Conventional
Conventional instrumentation
Device: Conventional instrumentation
Experimental: PSI
Patient specific instrumentation
Device: PSI
Other Names:
  • Patient specific instrumentation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood loss
Time Frame: 5 days
According to Mercuriali et al.
5 days

Collaborators and Investigators

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

Sponsor

Cochin Hospital

Investigators

  • Study Director: Stephane Boisgard, MD, PhD, University Hospital, Clermont-Ferrand

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, 2011

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

December 1, 2013

First Submitted That Met QC Criteria

December 5, 2013

First Posted (Estimate)

December 6, 2013

Study Record Updates

Last Update Posted (Estimate)

December 6, 2013

Last Update Submitted That Met QC Criteria

December 5, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCP SC 2837

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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