NCT07574762

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
34mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Jan 2026Jan 2029

Study Start

First participant enrolled

January 26, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2029

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

2.6 years

First QC Date

April 28, 2026

Last Update Submit

May 5, 2026

Conditions

Osteoarthritis

Keywords

RoboticNavigationArthroplastyOsteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Forgotten Joint Score (FJS).

    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.

Secondary Outcomes (6)

  • Knee Injury and Osteoarthritis Outcome Score (KOOS).

    3, 12, and 24 months postoperatively.

  • Self Knee Value (SKV).

    3, 12, and 24 months postoperatively.

  • Net Promoter Score (NPS)

    3, 12, and 24 months postoperatively.

  • Active Range of Motion.

    Preoperatively, and at 3 months, 12 months, and 24 months postoperatively.

  • Operative Time

    During the surgical procedure (Day 0).

  • +1 more secondary outcomes

Study Arms (2)

Robotic

EXPERIMENTAL

Patients undergoing Prosthetic knee arthroplasty under robotic assistance

Device: Robotic-Arm Assisted Surgery (RA)

Navigation

ACTIVE COMPARATOR

Patients undergoing Prosthetic knee arthroplasty under navigation assistance

Device: Computer-Assisted Navigation (CAN)

Interventions

Robotic-Arm Assisted Surgery (RA)DEVICE

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.

Robotic
Computer-Assisted Navigation (CAN)DEVICE

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.

Navigation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe hospitalier Diaconesses Croix Saint Simon

Paris, Paris, 75020, France

RECRUITING

Related Publications (2)

  • Clark TC, Schmidt FH. Robot-Assisted Navigation versus Computer-Assisted Navigation in Primary Total Knee Arthroplasty: Efficiency and Accuracy. ISRN Orthop. 2013 Jun 24;2013:794827. doi: 10.1155/2013/794827. eCollection 2013.

    PMID: 24967115BACKGROUND

  • Geng X, Zheng Y, Li Y, Zhao M, Liu Y, Li Z, Cai H, Zhang M, Yan X, Sun Z, Lv X, Guo F, Li F, Tian H. Early Radiographic and Clinical Outcomes of Robotic-arm-assisted versus Conventional Total Knee Arthroplasty: A Multicenter Randomized Controlled Trial. Orthop Surg. 2024 Nov;16(11):2732-2740. doi: 10.1111/os.14196. Epub 2024 Aug 12.

    PMID: 39135273BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Younes KERROUMI, Clinical Research Physician

CONTACT

+33144643384ykerroumi@hopital-dcss.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Model Type: Parallel Assignment. Number of Arms: 2 arms (Navigation vs. Robotic). Allocation: Randomized. Masking: Single Blind (Outcomes Assessor). While the surgeon cannot be blinded to the technology used during the procedure, the functional outcomes and scores (FJS, KOOS, SKV) are typically assessed in a way to minimize bias, and the protocol notes a rigorous randomization procedure to ensure impartiality.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2026

First Posted

May 8, 2026

Study Start

January 26, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

January 26, 2029

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)