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Positioning of the Tibial Cut in Unicompartmental Medial Knee Replacement by Using Patient Specific Cutting Guides. (PSI-PUC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02018484
First Posted: December 23, 2013
Last Update Posted: August 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rennes University Hospital
  Purpose

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.


Condition Intervention
Knee Prosthesis Procedure: Unicompartmental Knee Replacement

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Positioning of the Tibial Cut in Unicompartmental Medial Knee Replacement by Using Patient Specific Cutting Guides.

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Success rate in performing the tibial cut [ Time Frame: Month 6 ]

    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.



Secondary Outcome Measures:
  • Success rate in conserving a residual varus. [ Time Frame: Month 6 ]
    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 ]

Enrollment: 32
Study Start Date: December 2013
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patient specific cutting guides
Unicompartmental knee replacement with patient specific cutting guides
Procedure: Unicompartmental Knee Replacement

Detailed Description:

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.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients aged 18 or older;
  • indication of medial unicompartmental knee replacement (validated by the orthopedic surgeons staff) ;
  • written informed consent.

Exclusion Criteria:

  • MRI contraindication ;
  • Absence of the main investigator or the associated scientist during the surgical procedure ;
  • Adults under legal protective regimen or deprived of liberty.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02018484


Locations
France
Chu Rennes
Rennes, France, 35000
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: Jean-Christophe Lambotte, MD Rennes University Hospital
Study Chair: Bruno Laviolle, MD, PhD CIC INSERM 0203 CHU de RENNES
  More Information

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT02018484     History of Changes
Other Study ID Numbers: 2013-A01337-38
First Submitted: December 9, 2013
First Posted: December 23, 2013
Last Update Posted: August 19, 2016
Last Verified: March 2016

Keywords provided by Rennes University Hospital:
Surgery / Knee / Replacement / MRI / Specific cutting guides