Difference in Patellar Tracking Before and After Journey II BCS Total Knee Arthroplasty, Evaluated With 4D CT Imaging

NCT05824533 | Terminated

• 1 other identifier: 4DCT-tracking-TKA
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

Brief Summary

The current proposal aims to investigate the patellar tracking in adult patients receiving Journey II Bi-Cruciate Stabilized (BCS) total knee arthroplasty (TKA) before and one year after surgery, positioned with the CORI Robotics System instrumentation. The hypothesis is that less change in patella tracking before and after surgery will lead to less anterior knee pain complaints. Patella tracking is investigated using 4Dimensional Computer Tomography (4D CT) imaging. Researchers will compare the group of participants that will receive a patella onlay button with the group that will not receive a patella onlay button with their TKA to see if there is a difference in motion and pain experienced by the participants.

Conditions

Knee; Replacement; Arthroplasty

Outcome Measures

Primary Outcomes (4)

• Changes in patellar shift during knee flexion between the pre- and one year post-operative situation

  This will be measured with 4DCT imaging.

  pre-operative, and 12 months post-operative

• Changes in patellar tilt during knee flexion between the pre- and one year post-operative situation

  This will be measured with 4DCT imaging.

  pre-operative, and 12 months post-operative

• Difference between pre-operative and one year post-operative in pain

  Pain will be measured using the NRS scale. The numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable.

  pre-operative, and 12 months post-operative

• Difference in patella tracking between patients with and without an onlay patella button

  This will be measured with 4DCT imaging. The Patellar Center - Trochlear Groove distance will be used to quantify patellar tracking throughout an extension-flexion movement.

  pre-operative, and 12 months post-operative

Secondary Outcomes (6)

• Implant positioning

  during surgery

• Patient Reported Outcome Measures (PROMs): Forgotten Joint Score (FJS)

  pre-operative, 3, 6, 12 months post-operative

• PROMs: Knee Injury and Osteoarthritis Outcome Score (KOOS)

  pre-operative, 3, 6, 12 months post-operative

• PROMs: Kujala knee score

  pre-operative, 3, 6, 12 months post-operative

• PROMs: EuroQol Five-Dimensional Five-Level (EQ-5D-L)

  pre-operative, 3, 6, 12 months post-operative

Study Arms (2)

TKA with onlay patella button

EXPERIMENTAL

Total knee arthroplasty (TKA) with a patella placed with the use of the CORI based on pre-operative 4DCT images of the knee.

Device: onlay patella button

TKA without onlay patella button

ACTIVE COMPARATOR

Total knee arthroplasty (TKA) placed with the use of the CORI based on pre-operative 4DCT images of the knee.

Procedure: Conventional procedure; NO onlay patella button

Interventions

onlay patella button DEVICE

Total knee arthroplasty (TKA) with a patella onlay button placed with a CORI Robotics System based on pre-operative 4DCT-imaging.

TKA with onlay patella button

Conventional procedure; NO onlay patella button PROCEDURE

Total knee arthroplasty (TKA) placed with a CORI Robotics System based on pre-operative 4DCT-imaging.

TKA without onlay patella button

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-inflammatory knee osteoarthritis, which is confirmed by radiology.
• Osteoarthritis is unilateral or bilateral with the contralateral knee functioning properly, not operated on in the last 6 months.
• Set to receive a primary cemented total knee arthroplasty.
• Aged between 50 and 80 years, inclusive, on the day of the operation.
• This age limit of 50 is based on the desire to include exclusively patients with primary osteoarthritis. As osteoarthritis is an age-related disorder, it generally involves adults over the age of 50 years. Patients under the age of 50 years who present with osteoarthritis usually have osteoarthritis due to a secondary cause (e.g. post-traumatic osteoarthritis).
• A maximum age of 80 years will be employed. This age limit will be adopted because patients should be well able to perform an extension-flexion movement while a dynamic CT scan is made.
• In stable health (American Society of Anesthesiology (ASA)-score ≤ 3) and is free of or treated for cardiac, pulmonary, haematological, or other conditions that would pose excessive operative risk.
• Patient has a correctable or \<10° rigid (non-correctable) varus deformity of the knee.
• Participants must be able to give informed consent.
• Patient plans to be available for follow-up until two years post-operative.
• Ability to walk for 2 minutes without walking aid

You may not qualify if:

• Valgus deformity
• Body MAss Index (BMI) \> 35.
• Previous hip /knee/ankle replacement surgery in the last 12 months, or is planned to have a hip replacement in the next 6-12 months.
• Patient has had major, non-arthroscopic surgery to the study knee, including High Tibial Osteotomy (HTO).
• Patient has an active, local infection or systemic infection
• Incomplete or insufficient tissue surrounding the knee.
• Severe damage to the medial or collateral knee ligaments and popliteal tendon
• Documented osteoporosis with patient in active medical treatment.
• Patient has physical, emotional or neurological conditions that impacts gait or balance, or would compromise compliance with post-operative rehabilitation and follow-up.
• Bone quality compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis
• Knee flexion \< 90 degrees
• \> 30 degrees extension deficit (active restraint to extension)
• Patient does not have a proper functioning patella tendon on the affected side; measured as inability of active extension of the knee
• Patient has active rheumatoid arthritis, any auto-immune disorder, immunosuppressive disorder or a terminal illness.

Sponsors & Collaborators

• Sebastiaan van de Groes: lead
• Smith & Nephew, Inc.: collaborator
• Treant, the Netherlands: collaborator

Study Sites (2)

Treant, the Netherlands

Groningen, Netherlands

Location

RadboudUMC

Nijmegen, Netherlands

Location

Study Officials

• Sebastiaan van de Groes, MD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator & Orthopeadic surgeon

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 21, 2023
• Study Start: April 8, 2022
• Primary Completion: February 21, 2024
• Study Completion: February 21, 2024
• Last Updated: April 11, 2024

Record last verified: 2024-04

Locations

NL (2)