Prospective Functional Outcome Study of the Knee

Study Overview
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Brief Summary
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The purpose of this study is to obtain patient-oriented and clinically-oriented physical function outcomes both pre-operatively and post-operatively in patients receiving a total knee arthroplasty .

Detailed Description
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This study aims to use up to 75 patients at 3 centers to determine a baseline short-term postoperative physical function status of patients undergoing a total knee arthroplasty through patient and clinically based assessments. The KOOS score will collect data on the patient's physical function, stiffness, and pain. The BERG balance, TUG, and TUDS tests will be used quantitatively to assess the patient's ability to conduct activities of daily living like walking for an extended period of time, standing from a seated position, and maintaining balance while performing a series of actions.

Official Title
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Prospective Functional Outcome Study of the Knee

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Device: Total Knee Arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is a male or non-pregnant female age 18 years or older at time of study Patient is a candidate for a total knee arthroplasty Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation. Exclusion Criteria: Patients younger than 18 years of age Patients with a primary diagnosis other than osteoarthritis of the knee as determined by an orthopaedic surgeon Patients who have had any previous lower extremity procedure Patients with a BMI greater than or equal to 40 Patients with an active infection within the affected knee joint Patients with a neuromuscular or neurosensory deficiency that may limit the ability of the patient to evaluate the safety and efficacy of the device Patient is diagnosed with systemic disease or metabolic disorder leading to progressive bone deterioration (e.g. Lupus Erythematosus, Paget's Disease) Patient is immunologically suppressed or receiving chronic steroids in excess of normal physiological requirements (e.g. greater than 30 days) Patient has a known sensitivity to device materials Non-English speaking patients Patient is a prisoner

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Total Knee Arthroplasty patients<br>TKA patients | Device: Total Knee Arthroplasty<br>* Knee replacement<br>* Other names: ConforMIS, Off the shelf, TKA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional testing | Assess patient functional outcomes | 6 weeks post-op | 
| Functional testing | Assess patient functional outcomes | 6 months post-op | 
| Functional testing | Assess patient functional outcomes | 1-year post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome questionnaires | to assess knee pain and function | 6-weeks post-op | 
| Outcome questionnaires | to assess knee pain and function | 6-months post-op | 
| outcome questionnaires | to assess knee pain and function | 1-year post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, knee replacement, functional testing