Positioning of the Tibial Cut in Unicompartmental Medial Knee Replacement by Using Patient Specific Cutting Guides. (PSI-PUC)
Unicompartmental knee replacements are performed to treat osteoarthritis or osteonecrosis of the knee especially when it affects only the medial femoro-tibial compartment. To place the prosthesis, bone removal is necessary. The orientations of the bony cuts directly influence the position of the different elements of the prosthesis and the limb alignment. It is known that good positioning of the prosthesis is the key of a good survival of the implants. To guide the blade of the saw, cutting guides are used. The position of these guides gives the final position of the cuts. At present, two main techniques are used to position the guides: the conventional one, not very costly but not very accurate, and the navigated procedure, which is more accurate but also more expensive and more invasive. Since few years, patient specific cutting guides are used in total knee replacement with encouraging results and more recently in uni compartmental knee replacement with no scientific proof of efficiency.
This study aims to validate the procedure of patient specific cutting guides.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Positioning of the Tibial Cut in Unicompartmental Medial Knee Replacement by Using Patient Specific Cutting Guides.|
- Success rate in performing the tibial cut [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Success is defined as a correct orientation of the tibial cut which has to be within patient's target value (± 2°) at 6 months in both the frontal and the sagittal plans.
Failure of prosthesis implantation (defined by outranging patient's target value of more than 4º in the frontal or the sagittal plan or more than 3 mm on the cutting depth, controled by per operative navigated procedure) is considered as treatment failure.
- Success rate in conserving a residual varus. [ Time Frame: Month 6 ] [ Designated as safety issue: No ]Success is defined as a post-operative varus which does not exceed the patient's target value ± 3°, while respecting a 1° minimal varus.
- Variations of other orientation parameters of the tibial cut and limb alignment at the different times of the procedure (per and post operative) . [ Time Frame: Per-operative, and Month 6 ] [ Designated as safety issue: No ]
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Experimental: Patient specific cutting guides
Unicompartmental knee replacement with patient specific cutting guides
|Procedure: Unicompartmental Knee Replacement|
30 patients will be included in a mono centric, single-arm study with evaluation of the primary outcome by an independent expert comity. Each participant will have an MRI which will be sent to the society in charge of creating the patient specific cutting guides. The intervention will be performed using the patient specific cutting guides and in parallel, a station of navigation will be used to provide a safety control of the orientation of the cutting guide and to collect per operative data.
Evaluation visit is performed 6 months after surgery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02018484
|Contact: Jean-Christophe Lambotte, MDfirstname.lastname@example.org|
|Rennes, France, 35000|
|Contact: Jean-Christophe Lambotte, MD +33299266747 email@example.com|
|Principal Investigator: Jean-Christophe Lambotte, MD|
|Sub-Investigator: Nabil Najihi, MD|
|Sub-Investigator: Thomas Gicquel|
|Principal Investigator:||Jean-Christophe Lambotte, MD||Rennes University Hospital|
|Study Chair:||Bruno Laviolle, MD, PhD||CIC INSERM 0203 CHU de RENNES|