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OpenTrials
Completed

NCT Number: NCT01818401

Medico-economic Interest of the Patient Matched Cutting Blocks (Ancillary) MyKnee ® LBS During the Poses of Complete Prosthesis of Knee GMK ®. Multicentric, Prospective, Controlled, Opened, Randomised Study About a Medical Device. (My Knee)

Over 70.000 total knee arthroplasty (TKA) are performed in France every year, with a 10% yearly increase since the early 1990s. The clinical experience shows a strong rate of success on pain relief and on function. Longevity of the implants has been shown to be determined by the biomechanical design of the prosthesis, and by the implantation technique, especially the correct positioning of the bone cuts during the surgery. To improve the precision of these cuts, the patient matched cutting blocks developed by Medacta allow to adapt the bone cuts to the patient's anatomy, improving the reliability of this procedure. A reduction of the surgery time lengh and bleeding would be other benefits expected with this type of ancillary. The objective of this trial is to study the reliability of patient matched cutting blocks for total knee arthroplasty, by both clinical and radiological assessment, the effect on morbidity reduction during and after the procedure and also the benefit it could bring on an economic point of view.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Nantes

Nantes, France, 44000

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

all patients requiring a total knee arthroplasty line: primary or secondary osteoarthritis advanced beyond medical treatment.

Exclusion criteria

distorded axes or laxity requiring the establishment of constrained prosthesis

Treatment and study plan

the prosthesis GMK ® without the ancillary MyKnee ® LBS

Device

Matched patient cutting blocks MyKnee ® LBS

Device

Primary outcomes

  1. compare the functionality of the knee after installation of a total knee replacement between the 2 groups

    Time frame: 2 years after

    The evaluation will use a specific score for total knee arthroplasty: Part of the Knee Society function score (KSS) measured at 1 year after surgery.

Secondary outcomes

  1. to assess knee function by autoquestionnaire KOOS, the KSS knee score, operative time, procedure bleeding, reliability of the ancillary

    Time frame: 2 years after

  2. medico-economic evaluation type "Cost minimization"

    Time frame: 2 years after

    • Compare the costs of implementing the two strategies (A and B) taking into account the resources consumed (operative time, anesthetic drugs, blood bags ...).
    • Determine the least costly therapeutic intervention and medico-economic impact in the current system of financing of hospital expenditure.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Medico-economic Interest of the Patient Matched Cutting Blocks (Ancillary) MyKnee ® LBS During the Poses of Complete Prosthesis of Knee GMK ®. Multicentric, Prospective, Controlled, Opened, Randomised Study About a Medical Device.

Acronym: MY Knee

Important dates

Study start
2013
Primary completion
2016
Study completion
2025
First posted
Mar 26, 2013
Registry last updated
Jul 17, 2026

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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