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Completed

NCT Number: NCT04724915

Evaluation of Robot-assisted Total Knee Arthroplasty with Automatic Balancing

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

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University Hospital

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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).

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.

Primary outcomes

  1. Knee Laxity

    Time frame: Preoperative and postoperatively at 1 year.

    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.

Secondary outcomes

  1. Patient reported outcome measures

    Time frame: Preoperative

    The following patient reported outcome measures will be evaluated: Knee Injury and Osteoarthritis outcome score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems

  2. Patient reported outcome measures

    Time frame: Preoperative

    The following patient reported outcome measures will be evaluated: Knee Society Score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.

  3. Patient reported outcome measures

    Time frame: Preoperative

    The following patient reported outcome measures will be evaluated: EuroQoL. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.

  4. Patient reported outcome measures

    Time frame: Preoperative

    The following patient reported outcome measures will be evaluated: Pain Catastrophizing Scale. The score is a percentage score from 0 to 52, 0 representing no problems and 52 representing extreme problems.

  5. Change in patient reported outcome measures

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

    The change for the following patient reported outcome measures will be evaluated (compared to preoperatively): Forgotten Joint Score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.

  6. Change in patient reported outcome measures

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

    The change for the following patient reported outcome measures will be evaluated (compared to preoperatively): Knee Injury and Osteoarthritis outcome score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.

  7. Change in patient reported outcome measures

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

    The change for the following patient reported outcome measures will be evaluated (compared to preoperatively): Knee Society Score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.

  8. Change in patient reported outcome measures

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

    The change for the following patient reported outcome measures will be evaluated (compared to preoperatively): EuroQoL. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.

  9. Change in patient reported outcome measures

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

    The change for the following patient reported outcome measures will be evaluated (compared to preoperatively): Pain Catastrophizing Scale. The score is a percentage score from 0 to 52, 0 representing no problems and 100 representing extreme problems.

  10. Alignment

    Time frame: Preoperative and postoperatively at 6 weeks and 6 months.

    Coronal alignment on xrays. The lateral distal femoral angle (LDFA) will be evaluated. This is the angle between the mechanical femoral axis and the line between the distal articular surface of the femur. Additionally the medial proximal tibial angle (MPTA) will be evaluated. This is the line between the condylar surface and the mechanical axis of the tibia on a coronal radiograph.

  11. Knee laxity anteroposterior

    Time frame: Preoperative and postoperatively at 1 year.

    Sagittal knee laxity will be evaluated with stress examination. Sagittal knee laxity will be measured with an anteroposterior laxitymeter (GENOUROB; CE Marked). With a standardized setup, anteroposterior laxity can be obtained by measuring the anteroposterior deviation from the neutral position with up to 300 Newton of force.

  12. Knee kinematics in 3D after squat, knee flexion/extension, stair ascend and descend.

    Time frame: Postoperatively at 1 year.

    Knee kinematics in 3D obtained with fluoroscopy. Patients will be asked to perform squats, a flexion/extension movement, ascend and descend stairs. 3D motion of the prosthesis components can be obtained by projecting the 3D file of the prosthesis components onto the fluoroscopy images.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jan 26, 2021
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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