Prospective Clinical Study Evaluating Tibiofemoral Rotational Alignment Using Intraoperative Sensing During Total Knee Arthroplasty (TKA)

OrthoSensor

Status: Terminated

Conditions: Osteoarthritis

Treatments: Device: TKA with "Verasense"; Procedure: TKA without "Verasense"

Study type: Interventional

Funder types: Industry

Identifiers

NCT02286739

102

Details and patient eligibility

About

The objectives of the study are twofold: 1) Evaluate how intra-operative sensing may assist the surgeon with tibiofemoral rotational alignment by testing the precision and variability of setting tray rotation to the mid-third of the tibial tubercle. 2) Understand if patients with a combined axial rotation couple at the tibiofemoral joint and quantitative intercompartmental balance, achieved with the use of VERASENSE, exhibit less post-operative knee pain and improved clinical outcomes. Radiographic outcomes will also be assessed to measure post-operative alignment and to evaluate the prevalence and location of radiolucency and/or osteolysis.

Full description

Hypothesis: TKA with VERASENSE results in a more reliable and precise option for establishing implant-to-implant congruency and joint balance leading to less knee pain, faster return to normal activities and higher patient satisfaction compared to TKA without VERASENSE.

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients who meet the indications for use for Triathlon® Total Knee System using VERASENSE™
• Subject must be diagnosed with one or more of the following conditions
• osteoarthritis
• rheumatoid or other inflammatory arthritis
• post-traumatic arthritis
• Subject is likely to be available for all study visits
• Subject is able and willing to sign the informed consent and follow study procedures

Exclusion criteria

• Prior Total Knee Arthroplasty
• Avascular Necrosis
• Any knee surgery other than meniscectomy (can be arthroscopic or open)
• Ligament insufficiencies, prior surgeries such as anterior cruciate ligament (ACL) or PCL reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures
• Ipsilateral foot/ankle and hip arthritis
• Range of motion less than 90°, flexion contracture greater than 20°
• Subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
• Any subjects meeting any contraindication criteria as identified in the locally approved labeling for the device should be excluded from this study.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

500 participants in 2 patient groups

Group A TKA without VERASENSE

Sham Comparator group

Description:

Patients who undergo primary posterior cruciate ligament (PCL)-retaining or - sacrificing TKA without the use of VERASENSE to guide rotational alignment and balance.

Treatment:

Procedure: TKA without "Verasense"

Group B TKA with VERASENSE

Active Comparator group

Description:

Patients who undergo primary PCL-retaining or - sacrificing TKA with the use of VERASENSE to guide rotational alignment and balance.

Treatment:

Device: TKA with "Verasense"