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
1 other identifier
interventional
95
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 21, 2013
CompletedFirst Posted
Study publicly available on registry
March 26, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedOctober 9, 2017
October 1, 2017
3.8 years
March 21, 2013
October 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
2 years after
Secondary Outcomes (2)
to assess knee function by autoquestionnaire KOOS, the KSS knee score, operative time, procedure bleeding, reliability of the ancillary
2 years after
medico-economic evaluation type "Cost minimization"
2 years after
Study Arms (2)
Control group
OTHERThe control group will be constituted of patients with the prosthesis GMK ® without the ancillary MyKnee ® LBS.
Matched patient
OTHERThe treated group will consist of patients which the GMK ® prosthesis with ancillary ® MyKnee LBS.
Interventions
Eligibility Criteria
You may qualify if:
- all patients requiring a total knee arthroplasty line: primary or secondary osteoarthritis advanced beyond medical treatment.
You may not qualify if:
- distorded axes or laxity requiring the establishment of constrained prosthesis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Nantes
Nantes, 44000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2013
First Posted
March 26, 2013
Study Start
March 1, 2013
Primary Completion
December 1, 2016
Study Completion
September 1, 2025
Last Updated
October 9, 2017
Record last verified: 2017-10