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

NCT04037228 | Unknown

• 1 other identifier: 2017.458
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Arthroplasty; Replacement; Knee; Radiotherapy; Image-Guided

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Knee Functions measure by the Knee Society Score

  Through study completion, an average of 1 year

Study Arms (1)

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)

Interventions

KneeAlign 2 system (OrthAlign Inc, Aliso Viejo, California) DEVICE

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.

KneeAlign 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Osteoarthritis knee patients in hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Orthopaedics & Traumatology

Hong Kong, Hong Kong

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professional Consultant

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: July 30, 2019
• Study Start: April 30, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 7, 2023

Record last verified: 2023-12

Locations

HK (1)