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Completed

NCT Number: NCT02018484

Positioning of the Tibial Cut in Unicompartmental Medial Knee Replacement by Using Patient Specific Cutting Guides.

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.

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Key information

Conditions

Knee Prosthesis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Rennes

Rennes, 35000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Unicompartmental Knee Replacement

Procedure

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: PSI-PUC

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 23, 2013
Registry last updated
Aug 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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