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

NCT02018484 | Completed

• 1 other identifier: 2013-A01337-38
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Prosthesis

Keywords

Surgery / Knee / Replacement / MRI / Specific cutting guides

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Success rate in conserving a residual 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

Study Arms (1)

Patient specific cutting guides

EXPERIMENTAL

Unicompartmental knee replacement with patient specific cutting guides

Procedure: Unicompartmental Knee Replacement

Interventions

Unicompartmental Knee Replacement PROCEDURE

Patient specific cutting guides

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• MRI contraindication ;
• Absence of the main investigator or the associated scientist during the surgical procedure ;
• Adults under legal protective regimen or deprived of liberty.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Chu Rennes

Rennes, 35000, France

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Jean-Christophe Lambotte, MD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

• Bruno Laviolle, MD, PhD

  CIC INSERM 0203 CHU de RENNES

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 23, 2013
• Study Start: December 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: August 19, 2016

Record last verified: 2016-03

Locations

FR (1)