Assessment With Gait Analysis of Robotic Total Knee Arthroplasty Using Inverse Kinematic Alignment

NCT ID: NCT04912973

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2024-01-31

Brief Summary

Postoperative function and patient satisfaction are becoming increasingly relevant in patients after knee arthroplasty surgery. Despite adequate preoperative planning, improved surgical techniques and rehabilitation protocols, only 75%-85% of patients seems satisfied after TKA procedurs. Implant positioning and component alignment are determining factors in patient outcome. Currently, different alignment strategies in TKA surgery are used such as Mechanical Alignment (MA) and Kinematical Alignment (KA). Recently, a new and individualized alignment strategy (inverse Kinematic Alignment/iKA) was introduced. Preliminary 1-year results of iKA are promising, however, clinical and functional outcome on the medium and longterm should be investigated. This project aims to compare patients with iKA TKA with MA TKA on clinical, functional and biomechanical outcomes.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

inverse Kinematic Alignment

Group Type: ACTIVE_COMPARATOR

Robotically Assisted Total Knee Arthroplasty - Knee Replacement

Intervention Type: PROCEDURE

Robotically Assisted Total Knee Arthroplasty with a particular alignment strategy

adjusted Mechanical Alignment

Group Type: ACTIVE_COMPARATOR

Robotically Assisted Total Knee Arthroplasty - Knee Replacement

Intervention Type: PROCEDURE

Robotically Assisted Total Knee Arthroplasty with a particular alignment strategy

Interventions

Robotically Assisted Total Knee Arthroplasty - Knee Replacement

Robotically Assisted Total Knee Arthroplasty with a particular alignment strategy

Intervention Type: PROCEDURE

Other Intervention Names

Triathlon Total Knee System of Stryker with Mako Robotic Platform; Triathlon Total Knee Replacement of Stryker

Eligibility Criteria

Inclusion Criteria

1. Written informed consent must be obtained prior to any screening procedures

2. Received a primary total knee replacement (incl. patella) robotically-assisted

3. Male or female

4. Age between 50 and 80

5. Able to walk independently

Exclusion Criteria

1. Revision surgery

2. Patient with a history of neurological, psychiatric or neurodegenerative disease

3. Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.

4. Other musculoskeletal lesions that may affect the gait pattern

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AZ Delta

OTHER

Sponsor Role: collaborator

Philip Winnock de Grave, MD

OTHER

Sponsor Role: lead

Responsible Party

Philip Winnock de Grave, MD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

AZDelta

Roeselare, , Belgium

Countries

Belgium

Other Identifiers

B3222020000151

Identifier Type: -

Identifier Source: org_study_id