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 Overview

• Status: Completed
• Conditions: Knee Prosthesis
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35000
    • CHU Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Patient specific cutting guides; Unicompartmental knee replacement with patient specific cutting guides	Procedure: Unicompartmental Knee Replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate in performing the tibial cut	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.	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate in conserving a residual varus.	Success is defined as a post-operative varus which does not exceed the patient's target value ± 3°, while respecting a 1° minimal varus.	Month 6
Variations of other orientation parameters of the tibial cut and limb alignment at the different times of the procedure (per and post operative) .		Per-operative, and Month 6

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (ACTUAL): May 1, 2016
• Study Completion (ACTUAL): May 1, 2016

Study Registration Dates

• First Submitted: December 9, 2013
• First Submitted That Met QC Criteria: December 17, 2013
• First Posted (ESTIMATE): December 23, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): August 19, 2016
• Last Update Submitted That Met QC Criteria: August 18, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Surgery / Knee / Replacement / MRI / Specific cutting guides
• Other Study ID Numbers: 2013-A01337-38