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Evaluation Protocol of the Installation of Knee Unicompartmental Prosthesis (Journey (Smith & Nephew)) With Mechanical Ancillary Versus Robotic Assisted (Navio System). (PUC NAVIO)

Primary Purpose

Osteoarthritis Of Knee

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
internal PUC implanted with mechanical ancillary
Internal PUC implanted with robotic assistance
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Osteoarthritis Of Knee focused on measuring knee unicompartmental prosthesis, KneeKG system, robotic-assisted, alignment, implants positioning, International Knee Society, Forgotten joint score

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female adult (age ≥ 18 years)
  • Diagnosis of unicompartmental knee osteoarthritis ( osteoarthritis internal femoral tibial (AFTI))
  • Indication of unicompartmental knee arthroplasty of first intention posed

Exclusion Criteria:

  • History of femoral or tibial osteotomy of valgization or varisation
  • Reconstruction of the associated cruciate ligament
  • Refusal to participate in the study
  • Pregnant women, parturient or nursing mothers
  • Persons deprived of their liberty by a judicial decision or administrative staff, persons under psychiatric care, persons admitted to a health or social institution to other purposes.
  • Major persons subject to a legal protection measure or unable to express their consent
  • Patient not affiliated to a social security scheme
  • Patient participating in another interventional research excluding routine care research (former regulation) and category 2 searches not interfering with criterion analysis main

Sites / Locations

  • Hopital de la Croix Rousse

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

internal PUC implanted with mechanical ancillary

Internal PUC implanted with robotic assistance

Arm Description

Outcomes

Primary Outcome Measures

proportion of patients with Angle Hip Knee Ankle (HKA) (lower limb axis) restitution at 178 ° +/- 2 ° when the foot is touched with the floor and during the single support phase.
This criterion will be measured using a KneeKG system for dynamic analysis of knee movements. This system is non-invasive, non-radiating, non-painful. It is a dynamic tibiofemoral tracing device by infrared camera validated. The KneeKG system will be used according to its instructions for use.

Secondary Outcome Measures

Radiological positioning of implants
Measurements of HKA, frontal alignment of tibial and femoral implants, sagittal alignment of the femoral implant, tibial implant slope and the presence of peri-prosthetic edgings will be performed on a Standard radiography of the knee operated from the front, in profile and on a standing pangonometry
Comparison of the means of the International Knee Society (IKS) overall score between the groups.
This is the international benchmark for clinical and functional evaluation in knee surgery. The 2011 version provides a more accurate, complete and comprehensive vision than the previous version.
Comparison of the Forgotten Joint Score
The Forgotten score helps to analyze the patient's attention to the fact that his articulation has been replaced.

Full Information

First Posted
March 12, 2018
Last Updated
January 13, 2023
Sponsor
Hospices Civils de Lyon
Collaborators
Smith & Nephew, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03469193
Brief Title
Evaluation Protocol of the Installation of Knee Unicompartmental Prosthesis (Journey (Smith & Nephew)) With Mechanical Ancillary Versus Robotic Assisted (Navio System).
Acronym
PUC NAVIO
Official Title
Evaluation Protocol of the Installation of Knee Unicompartmental Prosthesis (Journey (Smith & Nephew)) With Mechanical Ancillary Versus Robotic Assisted (Navio System). Prospective, Monocentric, Randomized, Open Label Study.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
April 17, 2018 (Actual)
Primary Completion Date
July 10, 2020 (Actual)
Study Completion Date
January 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
Collaborators
Smith & Nephew, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Unicompartmental knee arthroplasty by unicompartmental prosthesis (PUC) is a treatment for isolated internal femoro-tibial osteoarthritis. This intervention is justified in cases of significant discomfort, failure of medical treatment and the absence of osteoarthritis in femoro tibial external and patellofemoral femoro compartments. It aims to replace the native internal femoral tibial articulation by a joint between two implants, without intervening on the other compartments. The functional results of PUC are superior and faster than those obtained with total knee arthroplasty (TKA). Its indications and its realization are on the other hand very demanding to allow an optimal functional result. Robotic-assisted surgery provides an excellent level of precision, which could allow better positioning of implants, compared to the use of a mechanical ancillary, according to the first published studies. The functional results and survival of these implants could also be improved. The internal PUC with mechanical ancillary is carried out for many years in the orthopedic surgery department of Croix Rousse. For 3 years this surgery is sometimes performed with robotic assistance. The investigators would like to prospectively evaluate the clinical and radiological impact of robotic-assisted surgery when performing a Journey unicompartmental prosthesis (Smith & Nephew). The assessment of alignment during walking seems to be a paramount parameter in the results of the PUC and has not so far been evaluated in this type of robotic-assisted surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis Of Knee
Keywords
knee unicompartmental prosthesis, KneeKG system, robotic-assisted, alignment, implants positioning, International Knee Society, Forgotten joint score

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
internal PUC implanted with mechanical ancillary
Arm Type
Active Comparator
Arm Title
Internal PUC implanted with robotic assistance
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
internal PUC implanted with mechanical ancillary
Intervention Description
The control group consists of patients operated with a mechanical ancillary (reference surgery in our department). In this technique, bone sections are made with a standardized ancillary (manually adjusted bone cutting guides), according to preoperative radiological planning. The positioning of the implants is done manually and controlled by the placement of test implants.
Intervention Type
Procedure
Intervention Name(s)
Internal PUC implanted with robotic assistance
Intervention Description
Patients are operated by robotics (surgery that we want to develop systematically in our service). 3D modeling of the knee allows the operator to perform a dynamic planning taking into account the reducibility of the deformation and the model of the implant. The operator can position the implants in three dimensions of the space without difficulty. This makes it possible to visualize, before the bone resections, the angular correction obtained between 0 and 130° flexion and alignment of the prosthesis by visualizing the contact points between the two implants. Bone resections will be performed using a guided retro bone drill. The system retracts more or less the cutter according to the bone thickness to be removed. This technique requires the insertion of two threaded plugs in the tibia and two in the femur to position the sensors that will allow the acquisition of anatomical landmarks of the lower limb and then 3D modeling
Primary Outcome Measure Information:
Title
proportion of patients with Angle Hip Knee Ankle (HKA) (lower limb axis) restitution at 178 ° +/- 2 ° when the foot is touched with the floor and during the single support phase.
Description
This criterion will be measured using a KneeKG system for dynamic analysis of knee movements. This system is non-invasive, non-radiating, non-painful. It is a dynamic tibiofemoral tracing device by infrared camera validated. The KneeKG system will be used according to its instructions for use.
Time Frame
At 6 month postsurgery
Secondary Outcome Measure Information:
Title
Radiological positioning of implants
Description
Measurements of HKA, frontal alignment of tibial and femoral implants, sagittal alignment of the femoral implant, tibial implant slope and the presence of peri-prosthetic edgings will be performed on a Standard radiography of the knee operated from the front, in profile and on a standing pangonometry
Time Frame
At 6 month and 24 month postsurgery
Title
Comparison of the means of the International Knee Society (IKS) overall score between the groups.
Description
This is the international benchmark for clinical and functional evaluation in knee surgery. The 2011 version provides a more accurate, complete and comprehensive vision than the previous version.
Time Frame
At 6 month and 24 month postsurgery
Title
Comparison of the Forgotten Joint Score
Description
The Forgotten score helps to analyze the patient's attention to the fact that his articulation has been replaced.
Time Frame
At 6 month and 24 month postsurgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female adult (age ≥ 18 years) Diagnosis of unicompartmental knee osteoarthritis ( osteoarthritis internal femoral tibial (AFTI)) Indication of unicompartmental knee arthroplasty of first intention posed Exclusion Criteria: History of femoral or tibial osteotomy of valgization or varisation Reconstruction of the associated cruciate ligament Refusal to participate in the study Pregnant women, parturient or nursing mothers Persons deprived of their liberty by a judicial decision or administrative staff, persons under psychiatric care, persons admitted to a health or social institution to other purposes. Major persons subject to a legal protection measure or unable to express their consent Patient not affiliated to a social security scheme Patient participating in another interventional research excluding routine care research (former regulation) and category 2 searches not interfering with criterion analysis main
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastien Lustig
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital de la Croix Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France

12. IPD Sharing Statement

Learn more about this trial

Evaluation Protocol of the Installation of Knee Unicompartmental Prosthesis (Journey (Smith & Nephew)) With Mechanical Ancillary Versus Robotic Assisted (Navio System).

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