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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02018484
Other study ID # 2013-A01337-38
Secondary ID
Status Completed
Phase N/A
First received December 9, 2013
Last updated August 18, 2016
Start date December 2013
Est. completion date May 2016

Study information

Verified date March 2016
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Unicompartmental Knee Replacement


Locations

Country Name City State
France Chu Rennes Rennes

Sponsors (1)

Lead Sponsor Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary 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 No
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