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

Sponsor

Orthosensor, Inc. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02286739

Collaborator

(none)

500

Enrollment

Locations

Arms

Duration (Months)

83.3

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Device: TKA with "Verasense" Procedure: TKA without "Verasense"	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Apr 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Group A TKA without VERASENSE will consist of 250 consecutive patients who will undergo primary PCL-retaining or - sacrificing TKA without the use of VERASENSE to guide rotational alignment and balance.	Procedure: TKA without "Verasense" TKA will be performed manually without the use of Verasense
Active Comparator: Group B TKA with VERASENSE will consist of 250 consecutive patients who will undergo primary PCL-retaining or - sacrificing TKA with the use of VERASENSE to guide rotational alignment and balance.	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.

Arm

Intervention/Treatment

Sham Comparator: Group A TKA without VERASENSE

will consist of 250 consecutive patients who will undergo primary PCL-retaining or - sacrificing TKA without the use of VERASENSE to guide rotational alignment and balance.

Procedure: TKA without "Verasense"

TKA will be performed manually without the use of Verasense

Active Comparator: Group B TKA with VERASENSE

will consist of 250 consecutive patients who will undergo primary PCL-retaining or - sacrificing TKA with the use of VERASENSE to guide rotational alignment and balance.

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.

Outcome Measures

Primary Outcome Measures

Knee Society Pain and Functional Scoring [Changes from baseline at 24 months]

Secondary Outcome Measures

Anterior Knee Pain Evaluation [Changes from baseline at 24 months]
EQ5D [Changes from baseline at 24 months]
Forgotten Joint Score [Changes from baseline at 24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Cleveland Clinic Foundation	Weston	Florida	United States
2	Emory University	Atlanta	Georgia	United States	30329
3	Illinois Bone & Joint Institute	Morton Grove	Illinois	United States	60053
4	NYU Hospital for Joint Diseases	New York	New York	United States	10003
5	The Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
6	Virginia Commonwealth University	Richmond	Virginia	United States