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

NCT ID: NCT04334304

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2024-11-11

Brief Summary

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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

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Conditions

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Osteo Arthritis Knee

Keywords

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Total Knee Arthroplasty Robot

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Posterior Stabilized TKA without robot-assistance

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

Group Type ACTIVE_COMPARATOR

Total Knee Prosthesis - type Posterior Stabilized

Intervention Type 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 with robot-assistance

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

Group Type EXPERIMENTAL

Robot-assisted Total Knee Arthroplasty

Intervention Type PROCEDURE

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

Total Knee Prosthesis - type Posterior Stabilized

Intervention Type 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 without robot-assistance

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

Group Type EXPERIMENTAL

Total Knee Prosthesis - type Bicruciate retaining

Intervention Type 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

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

Group Type EXPERIMENTAL

Total Knee Prosthesis - type Bicruciate retaining

Intervention Type 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).

Robot-assisted Total Knee Arthroplasty

Intervention Type PROCEDURE

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

Interventions

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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).

Intervention Type PROCEDURE

Robot-assisted Total Knee Arthroplasty

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

Intervention Type 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).

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jan Victor, PhD

Role: STUDY_CHAIR

UZ Ghent

Locations

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Ghent University Hospital

Ghent, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2018/1281 (BC-3831)

Identifier Type: -

Identifier Source: org_study_id