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

Not Applicable

Terminated

• Conditions: Osteoarthritis
• Interventions: Procedure: Control - Without the use of Verasense; Device: Sensor-assisted TKR (Verasense)

• Registration Number: NCT02290119
• Lead Sponsor: Orthosensor, Inc.

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-31
• Study First Submitted QC: 2014-11-08
• Study First Posted: 2014-11-13
• Study Start: 2018-04-01
• Primary Completion: 2022-10-12
• Study Completion: 2022-10-12
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-02
• Last Update Posted: 2023-02-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control - Without the use of Verasense	Control - Without the use of Verasense	Total Knee Replacement without the use of intraoperative sensors
Sensor-assisted TKR (Verasense)	Sensor-assisted TKR (Verasense)	Total Knee Replacement with the use of intraoperative sensors

Primary Outcome Measures

Name	Time	Method
Rehabilitation Potential	6 Months

Secondary Outcome Measures

Name	Time	Method
Knee Society Pain and Functional Scoring (KSS)	6 month	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.
3D Gait Analysis velocity	6 Month	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.
Forgotten Joint Score (FJS)	6 month	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.

Trial Locations

Locations (1)

Sinai Hospital of Baltimore - Rubin Institute of Advanced Orthopedics Center for Joint Preservation and Reconstruction; 🇺🇸 Baltimore, Maryland, United States