Evaluation of Standard and Robot Assisted Total Knee Arthroplasty with a Bicrucatie Retaining Prosthesis

The first study goal is to compare the outcomes between Posterior Stabilized and Bicruciate Retaining TKA. Additionally, the second goal is to evaluate the effect of robot assisted surgery in both Posterior Stabilized and Bicruciate Retaining TKA.

Study Overview

• Status: Terminated
• Conditions: Osteo Arthritis Knee
• Intervention / Treatment: Procedure: Total Knee Prosthesis - type Posterior Stabilized; Procedure: Robot-assisted Total Knee Arthroplasty; Procedure: Total Knee Prosthesis - type Bicruciate retaining

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Ghent University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Previous ligament trauma
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Posterior Stabilized TKA without robot-assistance; A TKA procedure will carried out: Posterior Stabilized TKA without robot-assistance	Procedure: Total Knee Prosthesis - type Posterior Stabilized; A total knee arthroplasty will be performed with a bicruciate retaining implant (Journey II, XR). The control group will consist out of patients receiving a posterior stabilized implant (Journey II, BCS).
Experimental: Posterior Stabilized with robot-assistance; A TKA procedure will carried out: Posterior Stabilized TKA with robot-assistance	Procedure: Total Knee Prosthesis - type Posterior Stabilized; A total knee arthroplasty will be performed with a bicruciate retaining implant (Journey II, XR). The control group will consist out of patients receiving a posterior stabilized implant (Journey II, BCS).; Procedure: Robot-assisted Total Knee Arthroplasty; A total knee arthroplasty will be performed with robot-assistance (NAVIO).
Experimental: Bicruciate retaining TKA without robot-assistance; A TKA procedure will carried out: Bicruciate retaining TKA without robot-assistance	Procedure: Total Knee Prosthesis - type Bicruciate retaining; A total knee arthroplasty will be performed with a bicruciate retaining implant (Journey II, XR). The control group will consist out of patients receiving a posterior stabilized implant (Journey II, BCS).
Experimental: Bicruciate retaining TKA with robot-assistance; A TKA procedure will carried out: Bicruciate retaining TKA with robot-assistance	Procedure: Robot-assisted Total Knee Arthroplasty; A total knee arthroplasty will be performed with robot-assistance (NAVIO).; Procedure: Total Knee Prosthesis - type Bicruciate retaining; A total knee arthroplasty will be performed with a bicruciate retaining implant (Journey II, XR). The control group will consist out of patients receiving a posterior stabilized implant (Journey II, BCS).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported outcome measures	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.	Preoperative
Patient reported outcome measures	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.	Preoperative
Patient reported outcome measures	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.	Preoperative
Patient reported outcome measures	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.	Preoperative
Change in patient reported outcome measures	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.	Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Change in patient reported outcome measures	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.	Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Change in patient reported outcome measures	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.	Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Change in patient reported outcome measures	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.	Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Change in patient reported outcome measures	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.	Postoperatively at 6 weeks, 6 months, 1 year and 2 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alignment	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.	Preoperative and postoperatively at 6 weeks and 6 months.
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.
Knee laxity	Sagittal knee laxity will be evaluated with stress examination. Sagittal knee laxity will be measured with an AP 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 300N of force.	Preoperative and postoperatively at 1 year.
Knee kinematics in 3D after squat, knee flexion/extension, stair ascend and descend.	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.	Postoperatively at 1 year.

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Investigators: Study Chair: Jan Victor, PhD, UZ Ghent

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): November 11, 2024
• Study Completion (Actual): November 11, 2024

Study Registration Dates

• First Submitted: March 7, 2020
• First Submitted That Met QC Criteria: April 2, 2020
• First Posted (Actual): April 6, 2020

Study Record Updates

• Last Update Posted (Actual): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Total Knee Arthroplasty; Robot
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 2018/1281 (BC-3831)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No