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

Ghent University Hospital (UZ)

Status: Terminated

Conditions: Osteo Arthritis Knee

Treatments: Procedure: Total Knee Prosthesis - type Bicruciate retaining; Procedure: Robot-assisted Total Knee Arthroplasty; Procedure: Total Knee Prosthesis - type Posterior Stabilized

Study type: Interventional

Funder types: Other

Identifiers

NCT04334304

2018/1281 (BC-3831)

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: Under 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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47 participants in 4 patient groups

Posterior Stabilized TKA without robot-assistance

Active Comparator group

Description:

A TKA procedure will carried out: Posterior Stabilized TKA without robot-assistance

Treatment:

Procedure: Total Knee Prosthesis - type Posterior Stabilized

Posterior Stabilized with robot-assistance

Experimental group

Description:

A TKA procedure will carried out: Posterior Stabilized TKA with robot-assistance

Treatment:

Procedure: Total Knee Prosthesis - type Posterior Stabilized

Procedure: Robot-assisted Total Knee Arthroplasty

Bicruciate retaining TKA without robot-assistance

Experimental group

Description:

A TKA procedure will carried out: Bicruciate retaining TKA without robot-assistance

Treatment:

Procedure: Total Knee Prosthesis - type Bicruciate retaining

Bicruciate retaining TKA with robot-assistance

Experimental group

Description:

A TKA procedure will carried out: Bicruciate retaining TKA with robot-assistance

Treatment:

Procedure: Robot-assisted Total Knee Arthroplasty

Procedure: Total Knee Prosthesis - type Bicruciate retaining