Total Knee Arthroplasty and Augmented Reality-based Navigation System

NCT ID: NCT05233930

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2025-10-31

Brief Summary

The purpose of Total Knee Replacement (TKR) is to remove worn cartilage surfaces and replace them with artificial parts of the same shape. TKR can be used in cases of osteoarthritis, inflammatory rheumatism, bone necrosis of the knee or following malformative or traumatic sequelae.

Implant alignment is paramount in TKR and the last years have seen a proliferation of alignment techniques following the introduction of computer and robotic-assisted surgery. Among Computer-assisted surgery, the augmented reality-based navigation system can be an option to improve accuracy in orthopaedic surgery.

The hypothesis of this study is: the use of augmented reality-based navigation system allows a prosthesis alignment and positioning that is at least as good as with the traditional mechanically aligned technique, and therefore improves knee functional results. This study also aims at assessing the cost-effectiveness of this new technology.

Detailed Description

In this randomised study, TKR will be performed either with the traditional mechanically aligned technique or with an augmented reality-based navigation system using Knee+ technology.

Knee+ is a Class Im software medical device (European classification, Directive 93/42/EEC, Annex IX) and obtained CE Mark 0459 in May 2020.

This technology is used in total knee replacement procedures, and offers the orthopedic surgeon intraoperative assistance in positioning the implants with the help of a pair of augmented reality glasses. The cutting planes are oriented with respect to the mechanical axes calculated according to anatomical landmarks acquired with a pointer. The connected glasses calculate precisely the 3D coordinates of the instruments thanks to the analysis of their specific markers (QR-Code), filmed by the integrated camera. The navigation information is displayed in the surgeon's field of vision, who interacts with the application thanks to the glasses' accelerometers.

Conditions

Gonarthrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TKR with augmented reality-based navigation system.

This technology offers the orthopedic surgeon intraoperative assistance in positioning the implants with the help of a pair of augmented reality glasses. The cutting planes are oriented with respect to the mechanical axes calculated according to anatomical landmarks acquired with a pointer. The connected glasses calculate precisely the 3D coordinates of the instruments thanks to the analysis of their specific markers (QR-Code), filmed by the integrated camera. The navigation information is displayed in the surgeon's field of vision, who interacts with the application thanks to the glasses' accelerometers.

Group Type: EXPERIMENTAL

TKR with augmented reality-based navigation system

Intervention Type: PROCEDURE

Surgery

TKR with traditional mechanically aligned technique.

TKR with traditional mechanically aligned technique will be performed according to local practice and standard guidelines.

Group Type: ACTIVE_COMPARATOR

TKR with traditional mechanically aligned technique

Intervention Type: PROCEDURE

As per local practice and standard guidelines.

Interventions

TKR with augmented reality-based navigation system

Surgery

Intervention Type: PROCEDURE

TKR with traditional mechanically aligned technique

As per local practice and standard guidelines.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Gonarthrosis on a varum knee requiring a Total Knee Replacement

2. Female or male, 18 years of age or older

3. Affiliation to a social security scheme

4. Patient has been informed of the study and has signed an informed consent form

Exclusion Criteria

1. Osteonecrosis,

2. Post traumatic osteoarthritis with femoral or tibial callus,

3. History of tibial or femoral osteotomy,

4. Valgum knee,

5. Isolated patellofemoral osteoarthritis,

6. Significant hip dysplasia or other excessive pelvic deformity,

7. Patient already equipped with medical devices that may conflict with the instrumentation required for augmented reality navigation,

8. Pregnant or breastfeeding women,

9. Patients under legal protection.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Elsan

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frédéric Dalat, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Médico-Chirurgical de Tronquières

Locations

Centre Médico-Chirurgical de Tronquières

Aurillac, , France

Countries

France

Central Contacts

Frédéric Dalat, MD

Role: CONTACT

fred.dalat@hotmail.fr

04 71 45 42 54 ext. +33

References

Panjwani TR, Mullaji A, Doshi K, Thakur H. Comparison of Functional Outcomes of Computer-Assisted vs Conventional Total Knee Arthroplasty: A Systematic Review and Meta-Analysis of High-Quality, Prospective Studies. J Arthroplasty. 2019 Mar;34(3):586-593. doi: 10.1016/j.arth.2018.11.028. Epub 2018 Dec 2.

Reference Type: BACKGROUND

PMID: 30611520 (View on PubMed)

Cheng T, Pan XY, Mao X, Zhang GY, Zhang XL. Little clinical advantage of computer-assisted navigation over conventional instrumentation in primary total knee arthroplasty at early follow-up. Knee. 2012 Aug;19(4):237-45. doi: 10.1016/j.knee.2011.10.001. Epub 2011 Nov 29.

Reference Type: BACKGROUND

PMID: 22130355 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/30611520/

Computer-assisted navigation system (CAS) in total knee arthroplasty (TKA) has been shown to improve mechanical alignment and prosthesis positioning as compared to conventional TKA.

https://pubmed.ncbi.nlm.nih.gov/22130355/

Even though computer-assisted navigation systems have been shown to improve the accuracy of implantation of components into the femur and tibia, long-term results are lacking

Other Identifiers

2021-A02549-32

Identifier Type: OTHER

Identifier Source: secondary_id

TKA and augmented reality

Identifier Type: -

Identifier Source: org_study_id