Evaluation of Robot-assisted Total Knee Arthroplasty with Automatic Balancing

NCT04724915 | Completed

• 1 other identifier: 2018/1281bis
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal is to evaluate the outcomes and learning curve of a robot-assisted total knee arthroplasty device with automatic ligament balancing.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Knee Laxity

  Coronal knee laxity will be evaluated with stress examination. Coronal stress will be evaluated with a stress radiograph. The deviation between the neutral position and position under stress will be measured on a coronal radiograph. The angle between the joint lines will be measured on the coronal radiograph.

  Preoperative and postoperatively at 1 year.

Secondary Outcomes (12)

• Patient reported outcome measures

  Preoperative

• Patient reported outcome measures

  Preoperative

• Patient reported outcome measures

  Preoperative

• Patient reported outcome measures

  Preoperative

• Change in patient reported outcome measures

  Postoperatively at 6 weeks, 6 months, 1 year and 2 years.

Study Arms (2)

Robot-assisted TKA

EXPERIMENTAL

Patients undergoing TKA with the assistance of robot technology.

Procedure: Robot-Assisted Total Knee Arthroplasty

Conventional TKA

ACTIVE COMPARATOR

Patients undergoing TKA with manual instrumentarium

Procedure: Conventional Total Knee Arthroplasty

Interventions

Conventional Total Knee Arthroplasty PROCEDURE

People will undergo surgery to replace the knee joint with a prosthesis in case of osteoarthritis. This will be performed with manual instrumentarium (jig-based).

Conventional TKA

Robot-Assisted Total Knee Arthroplasty PROCEDURE

People will undergo surgery to replace the knee joint with a prosthesis in case of osteoarthritis. This will be performed with the help of a surgical robot.

Robot-assisted TKA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• End stage osteoarthritis of the knee joint with failed conservative treatment

You may not qualify if:

• Previous ligament trauma of the MCL/LCL
• Previous fracture of femur or tibia
• Fixed flexion contracture \> 10°
• Flexion \< 110°
• Coronal deformity \> 15°
• Previous infection of the knee joint
• Ligament insufficiency
• Neurologic conditions

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Related Publications (1)

• Vermue H, Arnout N, Tampere T, Stroobant L, Dereu A, Victor J. Standardized Intraoperative Robotic Laxity Assessment in TKA Leads to No Clinically Important Improvements at 2 Years Postoperatively: A Randomized Controlled Trial. Clin Orthop Relat Res. 2025 Oct 1;483(10):1866-1874. doi: 10.1097/CORR.0000000000003505. Epub 2025 Apr 16.

  PMID: 40258174 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Jan Victor, MD, PhD

  UZ Ghent

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Masked investigators will be responsible for the data processing and analysis. Reporting will be done together with non-masked authors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Arm 1: Robot-assisted total knee arthroplasty Arm 2: Conventional jig-based total knee arthroplasty

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 26, 2021
• Study Start: September 1, 2020
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)