Total Knee Arthroplasty Functional Outcomes Study Research Design

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 post-operative 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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Total Knee Arthroplasty Functional Outcomes Study Research Design

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Device: Total knee arthroplasty patients


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is 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 with a primary diagnosis other than osteoarthritis of the knee as determined by an orthopedic 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 Patients diagnosed with systemic disease or metabolic disorder leading to progressive bone deterioration (e.g. Lupus Erythematosus, Paget's disease) Patients immunologically suppressed or receiving chronic steroids in excess of normal physiological requirements (e.g. greater than 30 days) Patients with 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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Accepts Healthy Volunteers

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>ConforMIS iTotal (CR) knee implant system and off-the-shelf knee implant systems from various manufacturers | Device: Total knee arthroplasty patients<br>* ConforMIS iTotal (CR) knee implant system & off-the-shelf standard knee implant system from various manufacturers<br>* Other names: joint replacement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Functional Tests at 6 weeks | Assess patient functional outcomes over time. Comparing times from pre-op to post op of patients performing the same functional tests. | 6 weeks post-op | 
| Timed Functional testing at 6 months | Assess patient functional outcomes over time. Comparing times from pre-op to post op of patients performing the same functional tests. | 6 months post op | 
| Timed Functional Testing at 1 year | Assess patient functional outcomes over time. Comparing times from pre-op to post op of patients performing the same functional tests. | 1 year post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome questionnaires at 6 weeks | Assess knee pain and function scores over time. Comparing questionnaire scores from pre-op to post op of patients. | 6 weeks post-op | 
| Outcome questionnaires at 6 months | Assess knee pain and function scores over time. Comparing questionnaire scores from pre-op to post op of patients. | 6 months post-op | 
| Outcome questionnaires at 1 year | Assess knee pain and function scores over time. Comparing questionnaire scores from pre-op to post op of patients. | 1 year post op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total knee arthroplasty, osteoarthritis