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Total Knee Arthroplasty With Personalized Implantation: Computer Navigation-Assisted Surgery Versus Robotic-Assisted Surgery (CAN-ARD)

5. mai 2026 oppdatert av: Groupe Hospitalier Diaconesses Croix Saint-Simon

Total Knee Replacement With Personalized Implantation Navigation-assisted Surgery Versus Robotic Assistance "CAN-ARD"

Title: Personalized Total Knee Arthroplasty: Computer-Assisted Navigation vs. Robotic Assistance (CAN-ARD).

Summary:

Knee osteoarthritis is frequently treated with Total Knee Arthroplasty (TKA). However, approximately 20% of patients remain dissatisfied following the procedure. This study aims to compare two surgical assistance technologies designed to improve prosthetic placement accuracy: Computer-Assisted Navigation (CAN) and Robotic-Arm Assistance (RA).

The primary objective is to determine if there is a significant difference in functional outcomes and the "forgotten joint" sensation (measured by the Forgotten Joint Score - FJS) between patients operated on with robotic assistance versus those with traditional navigation at 3, 12, and 24 months post-surgery. The study's hypothesis is that there is no major clinical difference between these two techniques when applied within a personalized alignment strategy.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Background and Rationale:

Personalized alignment in total knee arthroplasty combines the restoration of the patient's unique anatomy (restricted kinematic alignment) with joint stability. While computer-assisted navigation has been successfully used since 2003 to plan and control implant positioning, robotic assistance is gaining popularity due to its ability to perform more precise bone cuts using a haptic robotic arm. This study seeks to investigate whether this technical gain in precision translates into a real clinical benefit for the patient in terms of satisfaction and joint perception.

Study Design:

This is an interventional, prospective, randomized, single-center study. A total of 140 patients (70 per group) will be enrolled.

Interventions:

Participants will be randomly assigned to one of the following two arms:

Navigation Group: TKA implantation (Attune® CR) guided by an intraoperative computer navigation system.

Robotic Group: TKA implantation using a robotic-arm-assisted system (a motorized saw linked to the navigation software).

Follow-up and Evaluations:

Patients will be followed for 24 months. Evaluations will include:

Primary Endpoint: Forgotten Joint Score (FJS) at 3, 12, and 24 months.

Secondary Endpoints: Satisfaction and functional scores (KOOS, SKV, Net Promoter Score), range of motion measurements, operative time, and monitoring of any complications.

Target Population:

Adults (≥ 18 years) scheduled for primary total knee arthroplasty for osteoarthritis, with no history of major bone surgery on the affected limb.

Studietype

Intervensjonell

Registrering (Antatt)

140

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Frankrike
    • Paris
      • Paris, Paris, Frankrike, 75020
        • Rekruttering
        • Groupe Hospitalier Diaconesses Croix Saint Simon

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Patient providing written informed consent according to regulatory requirements
  • Male or female patients aged ≥18 years
  • Patients undergoing primary total knee arthroplasty for osteoarthritis
  • Use of Attune® prosthesis with posterior cruciate ligament retention (CR) and patellar resurfacing

Exclusion Criteria:

  • History of ligament reconstruction
  • Previous fracture or bone surgery (osteotomy) of the ipsilateral femur or tibia (except hip or ankle surgery)
  • Preoperative knee stiffness with flexion contracture >15° or flexion <90°
  • Individuals deprived of liberty by judicial or administrative decision
  • Patients not affiliated with a social security system
  • Patients unable to understand French
  • Patients with cognitive impairment
  • Patients whose place of residence makes close clinical follow-up impossible -- Women of childbearing potential without effective contraception
  • Pregnant or breastfeeding women

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Robotic
Patients undergoing Prosthetic knee arthroplasty under robotic assistance
Enhet: Robotic-Arm Assisted Surgery (RA)
Total Knee Arthroplasty (TKA) performed using a robotic-arm-assisted system connected to navigation software. Like the navigation group, this arm utilizes the personalized alignment strategy and the Attune® CR prosthesis. Instead of manual cutting guides, the surgeon manipulates a robotic arm equipped with a motorized saw to perform the bone cuts according to the pre-planned digital model. This technology is intended to increase the precision of bone resections.
Aktiv komparator: Navigation
Patients undergoing Prosthetic knee arthroplasty under navigation assistance
Enhet: Computer-Assisted Navigation (CAN)
Total Knee Arthroplasty (TKA) performed using an intraoperative computer navigation system. The procedure follows a personalized alignment strategy (restricted kinematic alignment combined with joint stability). After creating a digital model of the knee and mapping anatomical landmarks, the navigation system assists the surgeon in manually positioning the bone cutting guides. The primary implant used is the Attune® CR (Cruciate-Retaining) prosthesis with patellar resurfacing.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Forgotten Joint Score (FJS).
Tidsramme: 3, 12, and 24 months postoperatively.
Assessment of the patient's ability to forget the artificial joint in daily life. Minimum score: 0, Maximum score: 100. A higher score indicates a better outcome (the patient is less aware of the prosthetic joint)
3, 12, and 24 months postoperatively.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Knee Injury and Osteoarthritis Outcome Score (KOOS).
Tidsramme: 3, 12, and 24 months postoperatively.
Evaluation of the patient's opinion about their knee and associated problems. Minimum score: 0, Maximum score: 100. A higher score represents a better outcome.
3, 12, and 24 months postoperatively.
Self Knee Value (SKV).
Tidsramme: 3, 12, and 24 months postoperatively.
Patient's subjective assessment of their knee as a percentage of a normal knee. Scale: 0% to 100%. A higher percentage represents a better outcome.
3, 12, and 24 months postoperatively.
Net Promoter Score (NPS)
Tidsramme: 3, 12, and 24 months postoperatively.
A single-question survey used to measure patient satisfaction and their willingness to recommend the surgical procedure to others. The score is calculated based on responses to a single question on a scale of 0 to 10 (where 0 is "not at all likely" and 10 is "extremely likely"). Respondents are grouped as Promoters (9-10), Passives (7-8), or Detractors (0-6). The final NPS is calculated by subtracting the percentage of Detractors from the percentage of Promoters, resulting in a score ranging from -100 to +100. A higher score indicates higher patient satisfaction
3, 12, and 24 months postoperatively.
Active Range of Motion.
Tidsramme: Preoperatively, and at 3 months, 12 months, and 24 months postoperatively.
Measurement of the active flexibility (extension and flexion) of the operated knee using a goniometer. Measured in degrees
Preoperatively, and at 3 months, 12 months, and 24 months postoperatively.
Operative Time
Tidsramme: During the surgical procedure (Day 0).
Total duration of the surgical procedure, measured from the initial skin incision to the completion of skin closure.
During the surgical procedure (Day 0).
Incidence of Surgical and Postoperative Adverse Events.
Tidsramme: Through 24 months postoperatively.
Documentation of complications including:Intraoperative: Technology-related issues or interruption of surgical assistance. Postoperative: Revision surgery, manipulation under anesthesia, or implant loosening.
Through 24 months postoperatively.

Samarbeidspartnere og etterforskere

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Sponsor

Groupe Hospitalier Diaconesses Croix Saint-Simon

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

26. januar 2026

Primær fullføring (Antatt)

1. september 2028

Studiet fullført (Antatt)

26. januar 2029

Datoer for studieregistrering

Først innsendt

28. april 2026

Først innsendt som oppfylte QC-kriteriene

5. mai 2026

Først lagt ut (Faktiske)

8. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2025-A00665-44

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Nei

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