Clinical trial NCT04037228: Surgical Outcomes of the Accelerometer-based Navigation System for Total Knee Arthroplasty
Official title: Surgical Outcomes of the Accelerometer-based Navigation System for Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arthroplasty; Replacement; Knee
Radiotherapy; Image-Guided
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-07-30
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Osteoarthritis knee patients in hospital

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes of Radiological Assessments of the knees at baseline
timeFrame: Through study completion, an average of 1 year
measure: Changes of Radiological Assessments of the knees post-operatively
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Knee Functions measure by the Knee Society Score
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Orthopaedics & Traumatology
Study officials:
References: