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

Not Applicable

Terminated

• Conditions: Osteo Arthritis Knee
• Interventions: Procedure: Total Knee Prosthesis - type Bicruciate retaining; Procedure: Robot-assisted Total Knee Arthroplasty; Procedure: Total Knee Prosthesis - type Posterior Stabilized

• Registration Number: NCT04334304
• Lead Sponsor: University Hospital, Ghent

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-03-07
• Study First Submitted QC: 2020-04-02
• Study First Posted: 2020-04-06
• Primary Completion: 2024-11-11
• Study Completion: 2024-11-11
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 47

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bicruciate retaining TKA with robot-assistance	Robot-assisted Total Knee Arthroplasty	A TKA procedure will carried out: Bicruciate retaining TKA with robot-assistance
Posterior Stabilized with robot-assistance	Total Knee Prosthesis - type Posterior Stabilized	A TKA procedure will carried out: Posterior Stabilized TKA with robot-assistance
Bicruciate retaining TKA with robot-assistance	Total Knee Prosthesis - type Bicruciate retaining	A TKA procedure will carried out: Bicruciate retaining TKA with robot-assistance
Posterior Stabilized with robot-assistance	Robot-assisted Total Knee Arthroplasty	A TKA procedure will carried out: Posterior Stabilized TKA with robot-assistance
Bicruciate retaining TKA without robot-assistance	Total Knee Prosthesis - type Bicruciate retaining	A TKA procedure will carried out: Bicruciate retaining TKA without robot-assistance
Posterior Stabilized TKA without robot-assistance	Total Knee Prosthesis - type Posterior Stabilized	A TKA procedure will carried out: Posterior Stabilized TKA without robot-assistance

Primary Outcome Measures

Name	Time	Method
Patient reported outcome measures	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.
Change in patient reported outcome measures	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.

Secondary Outcome Measures

Name	Time	Method
Alignment	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.
Knee kinematics in 3D after squat, knee flexion/extension, stair ascend and descend.	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.
Knee laxity	Preoperative and postoperatively at 1 year.	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.

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Belgium