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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Rennes University Hospital
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT02018484
First received: December 9, 2013
Last updated: August 20, 2014
Last verified: August 2014
  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: 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.

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 ] [ 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.



Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
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)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02018484

Contacts
Contact: Jean-Christophe Lambotte, MD +33299266747 jean-christophe.lambotte@chu-rennes.fr

Locations
France
Chu Rennes Recruiting
Rennes, France, 35000
Contact: Jean-Christophe Lambotte, MD    +33299266747    jean-christophe.lambotte@chu-rennes.fr   
Principal Investigator: Jean-Christophe Lambotte, MD         
Sub-Investigator: Nabil Najihi, MD         
Sub-Investigator: Thomas Gicquel         
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

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT02018484     History of Changes
Other Study ID Numbers: 2013-A01337-38
Study First Received: December 9, 2013
Last Updated: August 20, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

ClinicalTrials.gov processed this record on August 21, 2014