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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) (MY Knee)

Primary Purpose

Osteoarthritis

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
the prosthesis GMK ® without the ancillary MyKnee ® LBS
Matched patient cutting blocks MyKnee ® LBS
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Osteoarthritis focused on measuring Ancillary tailored, medico-economic study,, total knee replacement, primary or secondary osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Nantes

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Control group

Matched patient

Arm Description

The control group will be constituted of patients with the prosthesis GMK ® without the ancillary MyKnee ® LBS.

The treated group will consist of patients which the GMK ® prosthesis with ancillary ® MyKnee LBS.

Outcomes

Primary Outcome Measures

compare the functionality of the knee after installation of a total knee replacement between the 2 groups
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 Outcome Measures

to assess knee function by autoquestionnaire KOOS, the KSS knee score, operative time, procedure bleeding, reliability of the ancillary
medico-economic evaluation type "Cost minimization"
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.

Full Information

First Posted
March 21, 2013
Last Updated
October 6, 2017
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01818401
Brief 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. (My Knee)
Acronym
MY Knee
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2013 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Ancillary tailored, medico-economic study,, total knee replacement, primary or secondary osteoarthritis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Other
Arm Description
The control group will be constituted of patients with the prosthesis GMK ® without the ancillary MyKnee ® LBS.
Arm Title
Matched patient
Arm Type
Other
Arm Description
The treated group will consist of patients which the GMK ® prosthesis with ancillary ® MyKnee LBS.
Intervention Type
Device
Intervention Name(s)
the prosthesis GMK ® without the ancillary MyKnee ® LBS
Intervention Type
Device
Intervention Name(s)
Matched patient cutting blocks MyKnee ® LBS
Primary Outcome Measure Information:
Title
compare the functionality of the knee after installation of a total knee replacement between the 2 groups
Description
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.
Time Frame
2 years after
Secondary Outcome Measure Information:
Title
to assess knee function by autoquestionnaire KOOS, the KSS knee score, operative time, procedure bleeding, reliability of the ancillary
Time Frame
2 years after
Title
medico-economic evaluation type "Cost minimization"
Description
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.
Time Frame
2 years after

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University Hospital of Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France

12. IPD Sharing Statement

Learn more about this trial

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)

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