Prospective Clinical Study Evaluating Tibiofemoral Rotational Alignment Using Intraoperative Sensing During TKA

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02286739
• Other study ID #: 102
• Status: Recruiting
• Phase: N/A
• First received: October 31, 2014
• Last updated: April 4, 2017
• Start date: April 2015
• Est. completion date: December 2018

Study information

• Verified date: April 2017
• Source: Orthosensor, Inc.
• Contact: Christopher R. Anderson, MS, MBA
• Phone: (954) 372-2641
• Email: canderson[@]orthosensor.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 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.

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Device:
• TKA with "Verasense"
VERASENSE replaces the standard tibial trial inserts and is embedded with microelectronics and sensors to provide surgeons with real-time knee kinetic data. The data is wirelessly transmitted to a graphic display (VERASENSE Knee Application), allowing surgeons to quantify and assess soft tissue intercompartmental loads throughout the range of motion. The VERASENSE sensor is not an investigational device. OrthoSensor, Inc., received FDA 510K clearance in 2009. The indication for use is a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE sensor is sterile and single patient use.

Procedure:
• TKA without "Verasense"
TKA will be performed manually without the use of Verasense

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Illinois Bone & Joint Institute	Morton Grove	Illinois
United States	NYU Hospital for Joint Diseases	New York	New York
United States	Virginia Commonwealth University	Richmond	Virginia
United States	The Cleveland Clinic Foundation	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Orthosensor, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Society Pain and Functional Scoring		Changes from baseline at 24 months
Secondary	Anterior Knee Pain Evaluation		Changes from baseline at 24 months
Secondary	EQ5D		Changes from baseline at 24 months
Secondary	Forgotten Joint Score		Changes from baseline at 24 months