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Evaluation of a New Navigation System in Computer-assisted Total Knee Arthroplasty (NaviKnee)

Primary Purpose

Gonarthrosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Computer-assisted arthroplasty
Sponsored by
GCS Ramsay Santé pour l'Enseignement et la Recherche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gonarthrosis

Eligibility Criteria

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

Inclusion Criteria:

  • Adult man or woman who has signed the informed consent for participation in the study,
  • Patient with primary uni or bilateral gonarthrosis
  • For whom an indication for total knee arthroplasty has been given

Exclusion Criteria:

  • History of fracture, arthroplasty or osteotomy of the knee
  • Severe preoperative laxity warranting a constrained prosthesis
  • Inflammatory rheumatic disease or any other progressive concomitant condition that may impact on the patient's functional prognosis
  • Traumatic articular or extra-articular deformities of the lower limb
  • Neurological disease, after-effects of a stroke
  • Mental deficiency or any other reason that may hinder the understanding or the strict application of the protocol
  • Patient not affiliated to the French social security system
  • Patient under legal protection, guardianship or curatorship
  • Patient already included in another therapeutic study protocol or having participated in another trial in the previous three months

Sites / Locations

  • Hôpital Privé Jean Mermoz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Computer-assisted arthroplasty

Conventional arthroplasty

Arm Description

Outcomes

Primary Outcome Measures

KSS M12
Assessment of functional outcome at 12 months by Knee Scoring System (KSS) score

Secondary Outcome Measures

KSS M3
Assessment of functional outcome at 3 months by Knee Scoring System (KSS) score
KOOS JR M3
Functional self-evaluation of the knee joint: Knee injury and Osteoarthritis Outcome Score (KOOS)
KOOS JR M12
Functional self-evaluation of the knee joint: Knee injury and Osteoarthritis Outcome Score (KOOS)
EQ-5D M3
Quality of life evaluation on EuroQol 5D
EQ-5D M12
Quality of life evaluation on EuroQol 5D
FJS M3
Self-evaluation of patient satisfaction with Forgotten Joint Score (FJS)
FJS M312
Self-evaluation of patient satisfaction with Forgotten Joint Score (FJS)
Surgery duration
Surgery duration
Hospitalization duration
Hospitalization duration
Lower limb alignment
Measurement of lower limb alignment in degrees of varus or valgus at M3 and M12
Postoperative outcome predictive factor
Description of a possible correlation between preoperative laxity and postoperative outcome
Safety analysis
Descriptive analysis of adverse events

Full Information

First Posted
December 14, 2021
Last Updated
June 22, 2022
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
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1. Study Identification

Unique Protocol Identification Number
NCT05435690
Brief Title
Evaluation of a New Navigation System in Computer-assisted Total Knee Arthroplasty
Acronym
NaviKnee
Official Title
Evaluation of a New Navigation System in Computer-assisted Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche

4. Oversight

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

5. Study Description

Brief Summary
Evaluation of a new navigation system in computer-assisted total knee arthroplasty.
Detailed Description
Single-blind, randomised, prospective comparative study in two parallel groups (conventional or computer-assisted arthroplasty). The patient will be evaluated during 3 visits: inclusion D0 (before arthroplasty), M3 (intermediate visit 3 months after arthroplasty) and M12 (final visit 12 months after arthroplasty).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gonarthrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-blind, randomised, prospective comparative study in two parallel groups (conventional or computer-assisted arthroplasty).
Masking
Participant
Allocation
Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Computer-assisted arthroplasty
Arm Type
Experimental
Arm Title
Conventional arthroplasty
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Computer-assisted arthroplasty
Intervention Description
Computer-assisted arthroplasty
Primary Outcome Measure Information:
Title
KSS M12
Description
Assessment of functional outcome at 12 months by Knee Scoring System (KSS) score
Time Frame
Month 12
Secondary Outcome Measure Information:
Title
KSS M3
Description
Assessment of functional outcome at 3 months by Knee Scoring System (KSS) score
Time Frame
Month 3
Title
KOOS JR M3
Description
Functional self-evaluation of the knee joint: Knee injury and Osteoarthritis Outcome Score (KOOS)
Time Frame
Month 3
Title
KOOS JR M12
Description
Functional self-evaluation of the knee joint: Knee injury and Osteoarthritis Outcome Score (KOOS)
Time Frame
Month 12
Title
EQ-5D M3
Description
Quality of life evaluation on EuroQol 5D
Time Frame
Month 3
Title
EQ-5D M12
Description
Quality of life evaluation on EuroQol 5D
Time Frame
Month 12
Title
FJS M3
Description
Self-evaluation of patient satisfaction with Forgotten Joint Score (FJS)
Time Frame
Month 3
Title
FJS M312
Description
Self-evaluation of patient satisfaction with Forgotten Joint Score (FJS)
Time Frame
Month 12
Title
Surgery duration
Description
Surgery duration
Time Frame
Day 0
Title
Hospitalization duration
Description
Hospitalization duration
Time Frame
Month 1
Title
Lower limb alignment
Description
Measurement of lower limb alignment in degrees of varus or valgus at M3 and M12
Time Frame
Month 12
Title
Postoperative outcome predictive factor
Description
Description of a possible correlation between preoperative laxity and postoperative outcome
Time Frame
Month 1
Title
Safety analysis
Description
Descriptive analysis of adverse events
Time Frame
Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult man or woman who has signed the informed consent for participation in the study, Patient with primary uni or bilateral gonarthrosis For whom an indication for total knee arthroplasty has been given Exclusion Criteria: History of fracture, arthroplasty or osteotomy of the knee Severe preoperative laxity warranting a constrained prosthesis Inflammatory rheumatic disease or any other progressive concomitant condition that may impact on the patient's functional prognosis Traumatic articular or extra-articular deformities of the lower limb Neurological disease, after-effects of a stroke Mental deficiency or any other reason that may hinder the understanding or the strict application of the protocol Patient not affiliated to the French social security system Patient under legal protection, guardianship or curatorship Patient already included in another therapeutic study protocol or having participated in another trial in the previous three months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean LANGLOIS, MD
Phone
0603294533
Ext
33
Email
jeangast@gmail.com
Facility Information:
Facility Name
Hôpital Privé Jean Mermoz
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean LANGLOIS, MD
Phone
0603294533
Ext
33
Email
jeangast@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of a New Navigation System in Computer-assisted Total Knee Arthroplasty

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