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GonarthrosisNCT05233930

Total Knee Arthroplasty and Augmented Reality-based Navigation System

A study testing TKR with augmented reality-based navigation system and TKR with traditional mechanically aligned technique in people with Gonarthrosis, run by Elsan at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gonarthrosis
What is being tested?
TKR with augmented reality-based navigation system and TKR with traditional mechanically aligned technique
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteFrance
Study dates
Sep 2024to Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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,
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Frédéric Dalat, MD contact

04 71 45 42 54 ext. +33

fred.dalat@hotmail.fr

France1 site

  • Centre Médico-Chirurgical de Tronquières

    Aurillac, 15000

Other trials in France

About this study

Official title: Does an Augmented Reality-based Navigation System in Total Knee Arthroplasty Allow a Better Alignment of the Lower Limb and Does it Improve Functional Results ? An Equivalence, Monocentric, Prospective and Randomized Study

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.

Read the 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
Being tested
TKR with augmented reality-based navigation system, TKR with traditional mechanically aligned technique
Keywords
TKR: total knee replacement
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TKR with augmented reality-based navigation systemProcedure or surgery

    Surgery

  • TKR with traditional mechanically aligned techniqueProcedure or surgery

    As per local practice and standard guidelines.

Study groups in NCT05233930
Study groupRoleWhat they receive
TKR with augmented reality-based navigation system.ExperimentalThis 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.
Receives: Procedure: TKR with augmented reality-based navigation system
TKR with traditional mechanically aligned technique.Active comparatorTKR with traditional mechanically aligned technique will be performed according to local practice and standard guidelines.
Receives: Procedure: TKR with traditional mechanically aligned technique

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 2 months after surgery

Secondary outcomes (11)

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

    Radiographic evaluation of the Hip-Knee-Ankle (HKA) angle on lower limb pangonogram at 1 year after surgery

    Measured: 1 year after surgery

  2. Evaluation of the success of the procedure

    The success of the procedure is defined by an HKA angle of 180°

    Measured: 2 months after surgery

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

    Radiographic evaluation of the Hip-Knee-Ankle (HKA) angle on lower limb pangonogram at 2 months and 1 year after surgery.

    Measured: 2 months and1 year after surgery

  4. Evaluation of radiological measurements between the two procedures

    Evolution of the following radiological parameters at 2 months and 1 year post-surgery:

    Femoral valgus Tibial varus Posterior tibial slope Flessum of the femoral implant Patellar tilt

    Measured: 2 months and1 year after surgery

  5. Evaluation of the knee score between the two procedures

    Evolution of the knee score at 2 months and 1 year postoperatively measured by the Knee Society Score (KSS). The KSS is a widely used clinician-assessed outcome score with good published validity data. The clinical part (Knee Score) of the KSS covers pain, range of motion, alignment and stability. The Function Score of the KSS covers patient mobility (walking distance and stairs) and potential walking aids. The KSS scoring scale ranges from 0 to 100 points for each part, with higher scores indicating less severe impairment.

    Measured: 2 months and1 year after surgery

  6. Quality of life assessment between the two procedures

    Change in quality of life at 2 months and 1 year measured by the Short Form-12 (SF-12) questionnaire.

    The SF-12 is a standardized self-questionnaire for measuring quality of life.The SF-12 is the shortened version of the SF-36.

    The SF-12 is made up of eight subscores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a scale from 0 to 100 on the assumption that each question has the same weight. The lower the score, the greater the handicap. The higher the score, the lower the handicap, i.e. a score of zero equals maximum handicap and a score of 100 equals zero handicap.

    Measured: 2 months and1 year after surgery

  7. Evaluation of knee pain between the two procedures

    Evolution of pain every day between D0 (postoperative) and D5, then once a week during the first month, then at 2 months, 3 months and at 1 year postoperative measured by a visual analog scale (VAS).

    The visual analog scale (VAS) for pain is a pain self-assessment tool. The patient defines his pain on a line 10cm long. The distance (in millimeters) from the left extremity defines the pain. The value zero corresponds to the lower limit defining the absence of pain and 100 to the upper limit corresponding to "the worst pain imaginable".

    Measured: From day 0 to day 5 ; Once a week during 1 month ; at 2 months ; at 3 months and 1 year after surgery

  8. Evaluation of the hemoglobin level between the two procedures

    Evolution of the hemoglobin level at D1 and D3

    Measured: From day 1 to day 3 after surgery

  9. Evaluation of the Average Length of Stay between the two procedures

    The Average Length of Stay will be evaluated in days from the hospital's entry and exit records.

    Measured: From the day of surgery at the time of hospital discharge up to 1 day

  10. Evaluation of the postoperative complications rate between the two procedures

    Occurrence of a thromboembolic complication (yes/no) during the 1-year post-operative follow-up.

    Occurrence of a surgical site infection (yes/no) during the 1-year post-operative follow-up.

    Occurrence of wound healing problems (yes/no) during the 1-year post-operative follow-up

    Measured: During 1 year post-operative

  11. Evaluation of the Quality-Adjusted Life Years (QALY) between the two procedures

    EQ-5D questionnaire at 1 year and collection of all costs during the first postoperative year.

    Measured: At 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2022
  2. Study startSep 2024 (estimated)
  3. Primary completionNov 2024 (estimated)
  4. Study completionOct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomised, double-arms, parallel, open-label study.
Masking
None (open label)
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05233930
Sponsor's protocol ID
TKA and augmented reality
Other IDs
2021-A02549-32
Status last verified
Jun 2024
First submitted
18 Jan 2022
Last updated
18 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 30611520

  • 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.

    PubMed 22130355

Questions about this trial

What is this clinical trial studying?

A study testing TKR with augmented reality-based navigation system and TKR with traditional mechanically aligned technique in people with Gonarthrosis, run by Elsan at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Frédéric Dalat, MD (04 71 45 42 54 ext. +33, fred.dalat@hotmail.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiographic evaluation of the Hip-Knee-Ankle (HKA) angle (time frame: 2 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05233930, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.

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