Clinical trial NCT02286739: Prospective Clinical Study Evaluating Tibiofemoral Rotational Alignment Using Intraoperative Sensing During Total Knee Arthroplasty (TKA)
Official title: Prospective Clinical Study Evaluating Tibiofemoral Rotational Alignment Using Intraoperative Sensing During Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoarthritis
Keywords: Total Knee Arthroplasty
Rotational Alignment
Intraoperative Sensors
Patient Outcomes
Soft Tissue Balance
Lead sponsor: Orthosensor, Inc.
Sponsor class: INDUSTRY
First posted: 2014-11-10
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Quantitatively Balanced and Unbalanced Knees in Primary Unilateral Total Knee Arthroplasty
timeFrame: Intra-operative with trial implants in place and after completing all surgical corrections.
Secondary outcomes:
measure: Knee Society Knee Scoring System
timeFrame: pre-operative, 6 weeks, 6 months, 1 year, 2 years
measure: Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).
timeFrame: Pre-operative, 6 weeks, 6 months, 1 year and 2 years
measure: Forgotten Joint Score (FJS)
timeFrame: 6 weeks, 6 months, 1 year, 2 years
Other outcomes:
Locations:
city: Weston
country: United States
facility: The Cleveland Clinic Foundation
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Morton Grove
country: United States
facility: Illinois Bone & Joint Institute
state: Illinois
city: New York
country: United States
facility: NYU Hospital for Joint Diseases
state: New York
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Greg Golladay, MD
role: PRINCIPAL_INVESTIGATOR
References: