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Clinical Trials/NCT03053453
NCT03053453
Terminated
Not Applicable

Evaluation of the Patient Reported Outcomes After Sensor-guided Total Knee Arthroplasty Under Spinal Anesthesia With Limited Motor-block.

NYU Langone Health1 site in 1 country52 target enrollmentDecember 6, 2016
ConditionsKnee Injuries

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Injuries
Sponsor
NYU Langone Health
Enrollment
52
Locations
1
Primary Endpoint
Knee Society Score (KSS)
Status
Terminated
Last Updated
2 years ago

Overview

Brief Summary

The purpose of this study will be to evaluate and compare patients undergoing total knee arthroplasty (TKA) with sensor guidance versus that of a standard technique. Each patient will be assessed for the difference between passive, soft tissue controlled, pressure balance and muscle activated pressure balance.

Registry
clinicaltrials.gov
Start Date
December 6, 2016
End Date
July 13, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients will be screened for eligibility based on whether they have chronic knee pain as a result of an arthritis-related condition.
  • Patient with chronic knee pain who is indicated for total hip or knee replacement surgery
  • Patient is at least 50 years of age
  • Patient is willing to participate in pre- and postoperative surveys

Exclusion Criteria

  • Failure to complete pre-operative surveys.
  • Revision Total Knee Arthroplasty
  • Prior ipsilateral knee surgery such as ligament reconstruction or osteotomy
  • Contralateral Total Knee Arthroplasty
  • Prior tibial plateau fracture
  • Ligamentous Insufficiency
  • History of fibromyalgia, chronic fatigue syndrome

Outcomes

Primary Outcomes

Knee Society Score (KSS)

Time Frame: Month 12 Post-Surgery

The Knee Society Score (KSS) comprises two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and \< 60 = poor.

Knee Injury and Osteoarthritis Outcome Score (KOOS)

Time Frame: Month 12 Post-Surgery

The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It is a 42-item questionnaire, including 5 subscales: symptoms, pain, function in daily living (ADLs), sports/recreation, and quality of life. The maximum score a patient can achieve is 100, indicating no knee problems. The minimum score is zero, indicating severe knee problems.

Study Sites (1)

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