Medico-economic Study of Patient Matched Cutting Blocks (Ancillary) MyKnee ® LBS During Knee Arthroplasty GMK ®.

September 3, 2015 updated by: Nantes University Hospital

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

Total knee arthroplasty represents over 70 000 surgical procedures per year in France, increasing about 10% each year since the early 1990s. Clinical experience shows a strong rate of success on pain relieve and improvement of knee articular function for these patients.

Longevity of the implants had been proved to depend on the biomechanical design and implantation techniques, particularly the bone cuts during the surgery. To improve the precision of these cuts, the patient matched cutting blocks developed by Medacta company allows to adapt bone cuts to the patient anatomy improving the reliability of these procedure. A reduction of surgical time and bleeding would be another benefit expected with this type of ancillary. The objective of this study is to demonstrate the advantage of patient matched cutting blocks for total knee arthroplasty on realiability for both clinical and radiological criteria, morbidity reduction during and after the procedure and also a benefit on an economic point of view.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France, 44000
        • University Hospital of Nantes

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control group
Control group will be constituted of patients with the prosthesis GMK ® without the ancillary MyKnee ® LBS.
Device: prosthesis GMK ® without the ancillary MyKnee ® LBS
Other: Matched patient
Treated group will consist of patients which the GMK ® prosthesis with ancillary ® MyKnee LBS.
Device: Matched patient cutting blocks MyKnee ® LBS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years after

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years after
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.
2 years after

Collaborators and Investigators

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

Sponsor

Nantes University Hospital

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

March 1, 2013

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

March 11, 2013

First Submitted That Met QC Criteria

March 15, 2013

First Posted (Estimate)

March 19, 2013

Study Record Updates

Last Update Posted (Estimate)

September 4, 2015

Last Update Submitted That Met QC Criteria

September 3, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC 12_0100

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.

Clinical Trials on Osteoarthritis

Clinical Trials on Matched patient cutting blocks MyKnee ® LBS

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe