This trial is active, not recruiting.

Condition osteoarthritis
Treatments sensor-assisted tkr (verasense), control - without the use of verasense
Sponsor Orthosensor, Inc.
Start date May 2014
End date January 2017
Trial size 40 participants
Trial identifier NCT02290119, 101


The primary objectives of this study are to understand the effects of soft-tissue balancing on Gait, function and rehabilitation potential after sensor-assisted Total Knee Arthroplasty and correlate Intra-operative subjective feel with OrthoSensor Outputs

Secondary objectives are to quantify and observe:

- Pain medication use

- Swelling

- Muscle strength and girth

- Gait efficiency

- Patient satisfaction

- Activity levels, functional return (i.e., back to work, resume normal activities)

- Patient perception of a balanced knee

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose basic science
(Sham Comparator)
Total Knee Replacement without the use of intraoperative sensors
control - without the use of verasense
Patients in this cohort will undergo manual total knee replacement without the use of Verasense
(Active Comparator)
Total Knee Replacement with the use of intraoperative sensors
sensor-assisted tkr (verasense)
Verasense is a single use, disposable device embedded with microelectronics into a standard tibial trial to provide dynamic, intraoperative feedback regarding limb alignment, tibiofermoral position and quantitative pressure at peak contact points in the medial and lateral compartments during total knee replacement surgery. Utilizing sensor-derived data, the surgeon can now evaluate intercompartmental loading throughout the range of motion, and correct for soft-tissue abnormalities while receiving real-time feedback regarding joint balance.

Primary Outcomes

Rehabilitation Potential
time frame: 6 Months

Secondary Outcomes

Knee Society Pain and Functional Scoring
time frame: 6 month
Forgotten Joint Assessment
time frame: 6 month
3D Gait Analysis
time frame: 6 Month

Eligibility Criteria

Male or female participants from 45 years up to 80 years old.

Inclusion Criteria: - Subject must be a candidate for a primary PCL retaining total knee arthroplasty - Subject must be diagnosed with one or more of the following conditions: osteoarthritis, avascular necrosis, rheumatoid or other inflammatory arthritis, post-traumatic arthritis - Subject is between the age of 45 - 80 years - 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, ligament insufficiencies, prior surgeries such as ACL or PCL reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures - Range of Motion less than 90 degrees, flexion contracture of more than 20 degrees

Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Orthosensor, Inc..