Prospective Functional Outcome Study of the Knee (PFOSK)
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ClinicalTrials.gov Identifier: NCT02079493
Recruitment Status : Unknown
Verified April 2014 by Tufts Medical Center. Recruitment status was: Recruiting
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 .
Condition or disease
Osteoarthritis of the Knee
Device: ConforMIS iTotal (CR) knee implant system and any off-the-shelf standard knee implant system from various manufacturers.
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.
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Ages Eligible for Study:
55 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Total knee arthroplasty patients
Patient is a male or non-pregnant female age 55 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.
Patients younger than 55 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