Medico-economic Study of Patient Matched Cutting Blocks (Ancillary) MyKnee ® LBS During Knee Arthroplasty GMK ®.
Primary Purpose
Osteoarthritis
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
prosthesis GMK ® without the ancillary MyKnee ® LBS
Matched patient cutting blocks MyKnee ® LBS
Sponsored by
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
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
Control group will be constituted of patients with the prosthesis GMK ® without the ancillary MyKnee ® LBS.
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
NCT ID
NCT01814384
First Posted
March 11, 2013
Last Updated
September 3, 2015
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01814384
Brief Title
Medico-economic Study of Patient Matched Cutting Blocks (Ancillary) MyKnee ® LBS During Knee Arthroplasty GMK ®.
Official Title
Medico-economic Study of Patient Matched Cutting Blocks (Ancillary) MyKnee ® LBS During Knee Arthroplasty GMK ®. Multicentric, Prospective, Controlled, Opened, Randomised Study About Medical Device.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
September 2016 (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
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.
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
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Other
Arm Description
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
Treated group will consist of patients which the GMK ® prosthesis with ancillary ® MyKnee LBS.
Intervention Type
Device
Intervention Name(s)
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 Study of Patient Matched Cutting Blocks (Ancillary) MyKnee ® LBS During Knee Arthroplasty GMK ®.
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