Surgical Outcomes of the Accelerometer-based Navigation System for Total Knee Arthroplasty

Osteoarthritis (OA) is a very common condition in the elderly population. Treatment for end-stage OA is total knee Replacement (TKR)

Study Overview

• Status: Recruiting
• Conditions: Arthroplasty; Replacement; Knee; Radiotherapy; Image-Guided
• Intervention / Treatment: Device: KneeAlign 2 system (OrthAlign Inc, Aliso Viejo, California)

Detailed Description

Overall the success rate of TKR is very high with high patient satisfaction and outcomes. Survivorship depends on patient selection and surgical techniques. Femoral and tibial component mal-alignment might lead to early failure.

Although recent studies have questioned the significance of overall postoperative mechanical alignment on survivorship, most studies still demonstrate alignment to be a crucial factor in the clinical success of TKA [1]. Ritter et al [2], in a review of 6070 TKAs, noted the risk of aseptic failure to significantly increase with a tibial component orientation less than 90° relatives to the tibial axis and a femoral component orientation greater than 8° of valgus relative to the femoral axis (failure rate, 8.7%).

Berend et al [3], in a review of 3152 TKAs, demonstrated that a tibial varus alignment of greater than 3° increased the odds of implant failure and medial bone collapse by roughly 17 times.

The most commonly used methods of component alignment in TKA are an extramedullary (EM) alignment guide for the tibial resection and an intramedullary (IM) alignment guide for the distal femoral resection. Unfortunately, these "conventional" methods have demonstrated a limited degree of accuracy for both overall mechanical alignment and individual component Method to create an even more accurate resection includes the use computer-assisted navigation technique. In a meta-analysis of 29 studies comparing computer assisted surgical (CAS) to conventional techniques in TKA (Mason et al). The authors found that only 68.2% of TKAs in the conventional group achieved an overall mechanical axis within 3° of neutral (vs 91.0% in the CAS group), 65.9% achieved a femoral varus/valgus alignment within 2° of perpendicular to the femoral mechanical axis (vs 90.4% in the CAS group) and 79.7% achieved a tibial varus/valgus alignment within 2° of perpendicular to the tibial mechanical axis (vs 95.2% in the CAS group).

However, despite these advantages, concerns regarding increased capital costs, operative times, extra pin sites, and the learning curve associated with the use of CAS techniques have continued to limit its widespread acceptance.

Another factor that might have limited its usage is that so far no study has shown the accuracy with CAS can directly lead to a longer survivorship of the implant or a better functional outcome. However, the most surgeon still believes a correct align knee will yield a better function and outcome.

This shed the light to a new navigation device. Iorio et.al [4]The KneeAlign 2 system (OrthAlign Inc, Aliso Viejo, California) is an accelerometer-based, portable navigation device for TKA that attempts to combine the alignment accuracy of large-console CAS systems, with the ease of use and convenience of conventional alignment methods. It is used to perform the proximal tibial and distal femoral resections in TKA. It does not require the use of a large console for registration and alignment feedback and is compatible with any TKA system. It consists of a disposable display console (2 × 4 × 2 inches in size) and a reference sensor, both of which are used for the tibial and femoral resections The KneeAlign 2 is the second version of the KneeAlign originally developed to perform only the proximal tibia resection in TKA. The KneeAlign 2 required the additional design of a femoral jig and cutting block and allows for the use of the same display console to perform both the proximal tibia and distal femur resections. The display console and reference sensor each contains triaxial accelerometers that communicate wirelessly with one another. The surgical technique for using the KneeAlign 2 to perform the tibial resection is the same as previously described Briefly, the tibial jig has 2 primary components (a fixed component and a mobile component) connected by a proximal articulation .The fixed component, with the attached reference sensor, is first pinned to the tibia. The purpose of the fixed component is to account for the movement of the tibia during cutting block alignment.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Department of Orthopaedics & Traumatology
    • Contact: Ki Wai Ho, MBChB, MSc, MRCSEd, FRCSEd; Phone Number: (852)35052715; Email: kevinho@cuhk.edu.hk
    • Principal Investigator: Ki Wai Ho, MBChB, MSc, MRCSEd, FRCSEd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Osteoarthritis knee patients in hospital

Description

Inclusion Criteria:

• Male and female subjects aged over 18 years old
• All patients must provide their written consent
• patients with a history of osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis who will receive a primary, posterior-stabilized TKA.
• All patients should have at least 8 years of school education;
• Radiological evidence of osteoarthritis with Kellgren and Lawrence grade 2 or above

Exclusion Criteria:

• Patients are planned to receive a unicondylar or patellofemoral arthroplasty.
• Patients with previous cases of alcoholism or drug abuse;
• Pregnancy and breast-feeding;
• Presence of serious pathologies;
• revision surgery
• Knee infection
• Non-consenting patients who have not provided the written Informed Consent;
• Mechanical instability, ligamentous laxity/deficiency and gross deformity

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

KneeAlign 2; Those of the group will be adopt KneeAlign 2: accelerometer-based navigation system at total knee arthroplasty.

Device: KneeAlign 2 system (OrthAlign Inc, Aliso Viejo, California); The KneeAlign 2 system (OrthAlign Inc, Aliso Viejo, California) is an accelerometer-based, portable navigation device for TKA that attempts to combine the alignment accuracy of large-console CAS systems, with the ease of use and convenience of conventional alignment methods. It is used to perform the proximal tibial and distal femoral resections in TKA. It consists of a disposable display console (2 × 4 × 2 inches in size) and a reference sensor, both of which are used for the tibial and femoral resections The display console and reference sensor each contains triaxial accelerometers that communicate wirelessly with one another. Briefly, the tibial jig has 2 primary components (a fixed component and a mobile component) connected by a proximal articulation .The fixed component, with the attached reference sensor, is first pinned to the tibia. The purpose of the fixed component is to account for the movement of the tibia during cutting block alignment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of Radiological Assessments of the knees at baseline	Standing antero-posterior (AP) hip-knee-ankle (HKA) and lateral knee-to-ankle radiographs will be performed to determine the varus/valgus alignment and the posterior slope of the tibial components relative to the mechanical axis.	Through study completion, an average of 1 year
Changes of Radiological Assessments of the knees post-operatively	Standing antero-posterior (AP) hip-knee-ankle (HKA) and lateral knee-to-ankle radiographs will be performed to determine the varus/valgus alignment and the posterior slope of the tibial components relative to the mechanical axis.	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Functions measure by the Knee Society Score	Questionnaire - Physician will assess on the Visual Analog Scale in pain score (None to Severe), Flexion Contracture (None to >20°), Extension lag (None to 20°), Total Range of Flexion (0-5° to 121-125°), Alignment (0° to Over 15°), Antero-posterior stability (<5mm to 10+mm), Mediolateral stability (<5° to 15°). Patients will record individuals' satisfaction, functional activities, and expectations.	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 20, 2019
• First Submitted That Met QC Criteria: July 29, 2019
• First Posted (Actual): July 30, 2019

Study Record Updates

• Last Update Posted (Actual): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2017.458

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No