Conventional Instrumentation, Computer Navigation, and Robotic Assistance Techniques in TKA

NCT05629715 | Withdrawn DMC FDA Device

• 1 other identifier: IRB#21-002140
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Knee osteoarthritis is a debilitating disease that can cause severe knee pain and significant limitations to patients' activities of daily living. Total knee arthroplasty (TKA), also known as knee replacement surgery, is a well-established and successful procedure for treatment of end-stage knee osteoarthritis. Over the years, TKA surgical techniques and implant technology have improved, resulting in better patient outcomes and implant survivorship. Despite continuous improvements being made to this high demand procedure, malalignment of component position is a well-known cause of post-operative complications, including knee pain, component loosening, and failure requiring revision surgery. Advanced techniques that utilize computer navigation or robotic-arm assistance have been developed in an attempt to avoid malalignment. Both technologies were created with the goal of improving the precision of implant positioning and implant sizing in order to improve lower limb alignment and joint line alignment. The OrthoAlign KneeAlign computer assisted navigation system is a commercially available device that uses gyroscopic limb position sensing technology mounted to intramedullary and extramedullary jigs to measure bone resection cuts in TKA that ultimately dictate implant position. The Zimmer Biomet ROSA Knee System is a commercially available, FDA-approved robotic assistant for performing TKA. It uses pre-operative x-rays to create a three-dimensional image of the patient's knee anatomy, which is used to create a pre-operative template of the implants to be used and provides intra-operative guidance for bone cuts during the TKA. The robotic system also assesses the soft tissue envelope around the knee and can assist with the soft tissue balancing of the knee arthroplasty. Alternatively, it can also be used in an imageless mode where bone cuts are performed based on intra-operative mapping using anatomic landmarks. To date, there have been no prospective studies comparing the implant positioning and patient outcomes directly of the KneeAlign system with the ROSA system and conventional TKA instrumentation techniques.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (6)

• Implant Positioning

  Radiographic evaluation of post-operative implant positioning compared to pre-operative planning.

  Pre-Op

• Implant Positioning

  Radiographic evaluation of post-operative implant positioning compared to pre-operative planning.

  Up to 6 Hours

• Implant Positioning

  Radiographic evaluation of post-operative implant positioning compared to pre-operative planning.

  6 weeks

• Implant Positioning

  Radiographic evaluation of post-operative implant positioning compared to pre-operative planning.

  3 months

• Implant Positioning

  Radiographic evaluation of post-operative implant positioning compared to pre-operative planning.

  6 months

• Implant Positioning

  Radiographic evaluation of post-operative implant positioning compared to pre-operative planning.

  1 year

Secondary Outcomes (41)

• Knee Questionnaire

  Pre-Op

• Knee Outcome Score

  Pre-Op

• Health Questionnaire

  Pre-Op

• Objective Knee Assessment

  Pre-Op

• Knee Alignment

  Pre-Op

Study Arms (3)

ROSA

ACTIVE COMPARATOR

Subjects randomly assigned to this arm will undergo a primary total knee arthroplasty procedure using the ROSA Knee System.

Device: ROSA Knee System

KneeAlign

ACTIVE COMPARATOR

Subjects randomly assigned to this arm will undergo a primary total knee arthroplasty procedure using the KneeAlign navigation system.

Device: KneeAlign Computer Assisted Navigation System

Conventional

NO INTERVENTION

Subjects randomly assigned to this arm will undergo a primary total knee arthroplasty procedure using conventional instrumentation.

Interventions

ROSA Knee System DEVICE

The Zimmer Biomet ROSA Knee System is a commercially available, FDA approved robotic assistant for performing TKA. It uses preoperative x-rays to create a three-dimensional image of the patient's knee anatomy which is used to create a preoperative template of the implants to be used and provides intraoperative guidance for bone cuts during the TKA. The robotic system also assesses the soft tissue envelope around the knee and can assist with the soft tissue balancing of the knee arthroplasty. Alternatively, it can also be used in an imageless mode where bone cuts are performed based on intra-operative mapping using anatomic landmarks.

ROSA

KneeAlign Computer Assisted Navigation System DEVICE

The OrthAlign KneeAlign computer assisted navigation system is a commercially available device that uses gyroscopic limb position sensing technology mounted to intramedullary and extramedullary jigs to measure bone resection cuts in TKA that ultimately dictate implant position.

KneeAlign

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is a minimum of 18 years of age
• Independent of study participation, patient is a candidate for commercially available Persona or Legion knee components implanted in accordance with product labeling
• Patient has participated in this study-related Informed Consent process
• Patient is willing and able to provide written Informed Consent by signing and dating the Institutional Review Board (IRB) or Ethics Committee (EC) approved Informed Consent form
• Patient is willing and able to complete scheduled study procedures and follow-up evaluations

You may not qualify if:

• Patient is currently participating in any other surgical intervention studies or pain management studies
• Patient has undergone contralateral unicompartmental knee arthroplasty (UKA) or total knee arthroplasty (TKA) within the last 18 months
• Hip pathology with significant bone loss (e.g., avascular necrosis of the femoral head with collapse, severe dysplasia of the femoral head or the acetabulum)
• Hip pathology severely limiting range of motion (e.g., arthrodesis, severe contracture, chronic severe dislocation)
• Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
• Patient has previously received partial or total knee arthroplasty for the ipsilateral knee
• Patients with active knee joint infections (determined clinically at time of pre-op evaluation)

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Santa Monica Medical Center

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A maximum of 300 subjects in each arm (900 total) are to be enrolled in this study. In order to minimize selection bias, the surgeon will randomize the instrumentation technique used. Randomization will be accomplished via a random number generator in Microsoft Excel in a 1:1:1 ratio. The patient will know which treatment arm they are in at the time of study consent. They will be ineligible for the study if they ask to change treatment arms.

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: November 29, 2022
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 13, 2024

Record last verified: 2024-08

Locations

US (1)