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

NCT04334304 | Terminated

• 1 other identifier: 2018/1281 (BC-3831)
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteo Arthritis Knee

Keywords

Total Knee Arthroplasty; Robot

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (4)

• Alignment

  Preoperative and postoperatively at 6 weeks and 6 months.

• Knee laxity

  Preoperative and postoperatively at 1 year.

• Knee laxity

  Preoperative and postoperatively at 1 year.

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

  Postoperatively at 1 year.

Study Arms (4)

Posterior Stabilized TKA without robot-assistance

ACTIVE COMPARATOR

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

Procedure: Total Knee Prosthesis - type Posterior Stabilized

Posterior Stabilized with robot-assistance

EXPERIMENTAL

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

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

Bicruciate retaining TKA without robot-assistance

EXPERIMENTAL

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

Procedure: Total Knee Prosthesis - type Bicruciate retaining

Bicruciate retaining TKA with robot-assistance

EXPERIMENTAL

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

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

Interventions

Total Knee Prosthesis - type Bicruciate retaining PROCEDURE

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).

Bicruciate retaining TKA with robot-assistance; Bicruciate retaining TKA without robot-assistance

Robot-assisted Total Knee Arthroplasty PROCEDURE

A total knee arthroplasty will be performed with robot-assistance (NAVIO).

Bicruciate retaining TKA with robot-assistance; Posterior Stabilized with robot-assistance

Total Knee Prosthesis - type Posterior Stabilized PROCEDURE

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).

Posterior Stabilized TKA without robot-assistance; Posterior Stabilized with robot-assistance

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Study Officials

• Jan Victor, PhD

  UZ Ghent

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Arm 1: Posterior Stabilized TKA without robot Arm 2: Posterior Stabilized TKA with robot Arm 3: Bicruciate retaining TKA without robot Arm 4: Bicruciate retaining TKA with robot

Study Record Dates

• First Submitted: March 7, 2020
• First Posted: April 6, 2020
• Study Start: January 1, 2020
• Primary Completion: November 11, 2024
• Study Completion: November 11, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)