Gait and Functional Improvement in Total Knee Arthroplasty With the Use of Verasense for Soft Tissue Balancing

Osteoarthritis Clinical Trial

Official title:

PILOT STUDY: Gait and Functional Improvement in Total Knee Arthroplasty With the Use of Verasense for Soft Tissue Balancing: A Randomized, Double-Blind, Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02290119
• Other study ID #: 101
• Status: Terminated
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: October 12, 2022

Study information

• Verified date: February 2023
• Source: Orthosensor, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: October 12, 2022
• Est. primary completion date: October 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Device:
• 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, tibiofemoral 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.

Procedure:
• Control - Without the use of Verasense
Patients in this cohort will undergo manual total knee replacement without the use of Verasense

Locations

Country	Name	City	State
United States	Sinai Hospital of Baltimore - Rubin Institute of Advanced Orthopedics Center for Joint Preservation and Reconstruction	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Orthosensor, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rehabilitation Potential		6 Months
Secondary	Knee Society Pain and Functional Scoring (KSS)	The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.	6 month
Secondary	Forgotten Joint Score (FJS)	The FJS is based on the patients' ability to forget about a joint as a result of the treatment. The FJS assessment is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities.	6 month
Secondary	3D Gait Analysis velocity	3D gait analysis relates to the range of motion of a joint and the movement velocity. The mean gait speed analysis is considered higher than 1 m/s.	6 Month