Total Knee Arthroplasty and Augmented Reality-based Navigation System

NCT05233930 | Not Yet Recruiting

• 2 other identifiers: TKA and augmented reality2021-A02549-32
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Gonarthrosis

Keywords

TKR: total knee replacement

Outcome Measures

Primary Outcomes (1)

• Radiographic evaluation of the Hip-Knee-Ankle (HKA) angle

  the Hip-Knee-Ankle (HKA) angle is measured on weight bearing pangonogram.

  2 months after surgery

Secondary Outcomes (11)

• Evaluation of long-term lower limb alignment between the two procedures

  1 year after surgery

• Evaluation of the success of the procedure

  2 months after surgery

• Assessment of lower limb alignment variability between the two procedures.

  2 months and1 year after surgery

• Evaluation of radiological measurements between the two procedures

  2 months and1 year after surgery

• Evaluation of the knee score between the two procedures

  2 months and1 year after surgery

Other Outcomes (1)

• Radiographic assessment

  At 2 months after surgery

Study Arms (2)

TKR with augmented reality-based navigation system.

EXPERIMENTAL

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.

Procedure: TKR with augmented reality-based navigation system

TKR with traditional mechanically aligned technique.

ACTIVE COMPARATOR

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

Procedure: TKR with traditional mechanically aligned technique

Interventions

TKR with augmented reality-based navigation system PROCEDURE

Surgery

TKR with augmented reality-based navigation system.

TKR with traditional mechanically aligned technique PROCEDURE

As per local practice and standard guidelines.

TKR with traditional mechanically aligned technique.

Eligibility Criteria

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

You may qualify if:

• Gonarthrosis on a varum knee requiring a Total Knee Replacement
• Female or male, 18 years of age or older
• Affiliation to a social security scheme
• Patient has been informed of the study and has signed an informed consent form

You may not qualify if:

• Osteonecrosis,
• Post traumatic osteoarthritis with femoral or tibial callus,
• History of tibial or femoral osteotomy,
• Valgum knee,
• Isolated patellofemoral osteoarthritis,
• Significant hip dysplasia or other excessive pelvic deformity,
• Patient already equipped with medical devices that may conflict with the instrumentation required for augmented reality navigation,
• Pregnant or breastfeeding women,
• Patients under legal protection.

Sponsors & Collaborators

• Elsan: lead

Study Sites (1)

Centre Médico-Chirurgical de Tronquières

Aurillac, 15000, France

Location

Related Publications (2)

• 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.

  PMID: 30611520 BACKGROUND

• 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.

  PMID: 22130355 BACKGROUND

Related Links

• 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.
• 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

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

tokaratoxin 2

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Frédéric Dalat, MD

  Centre Médico-Chirurgical de Tronquières

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frédéric Dalat, MD

CONTACT

04 71 45 42 54; fred.dalat@hotmail.fr

Study Design

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

Model Details: Randomised, double-arms, parallel, open-label study.

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: February 10, 2022
• Study Start: September 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: October 1, 2025
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

FR (1)