Fully Disposable Patient-Specific Instrumentation (MyKnee)

November 15, 2016 updated by: Moussa Hamadouche, Cochin Hospital

Primary TKA Using a Fully Disposable Patient-Specific Instrumentation: A Multicenter Controlled Study

To evaluate the lower limb alignment following total knee arthroplasty (TKA) performed with fully disposable patient-specific instrumentation versus conventional, versus patient specific instrumentation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators performed a controlled multicenter trial comparing the clinical and radiologic results and resources consumption of primary TKA using patient-specific cutting guides (PSCG) versus conventional instrumentation (CI), and compared the results to those obtained with a fully disposable patient-specific instrumentation (PSCG-D).

Study Type

Interventional

Enrollment (Actual)

210

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

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients 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
  • 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: CI
TKA using conventional instrumentation (CI)
Device: GMK Medacta Total Knee arthroplasty
Total Knee arthroplasty
Experimental: PSCG
TKA performed using Patient specific cutting guides (PSCG)
Device: GMK Medacta Total Knee arthroplasty
Total Knee arthroplasty
Experimental: PSCG-D
TKA performed using fully disposable Patient specific cutting guides (PSCG-D)
Device: GMK Medacta Total Knee arthroplasty
Total Knee arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HKA angle
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 Hip-Knee-Ankle (HKA) 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
% outliers
Time Frame: 3 months
% of patients with an HKA angle outside 180°+/- 3°
3 months
Knee Society Score
Time Frame: 3 months
Validated pain and function score following TKA
3 months
Oxford Knee Score
Time Frame: 3 months
Patients self assessment of knee function
3 months

Collaborators and Investigators

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

Sponsor

Cochin Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

September 26, 2016

First Submitted That Met QC Criteria

November 15, 2016

First Posted (Estimate)

November 17, 2016

Study Record Updates

Last Update Posted (Estimate)

November 17, 2016

Last Update Submitted That Met QC Criteria

November 15, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SC2900

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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