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

Osteo Arthritis Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04334304
• Other study ID #: 2018/1281 (BC-3831)
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: July 1, 2024

Study information

• Verified date: January 2024
• Source: University Hospital, Ghent
• Contact: Hannes Vermue, MD
• Phone: +3293322238
• Email: Hannes.Vermue[@]ugent.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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).
• Robot-assisted Total Knee Arthroplasty
A total knee arthroplasty will be performed with robot-assistance (NAVIO).
• 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).

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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	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.
Secondary	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.