Prospective Functional Outcome Study of the Knee

Stopped early

Conditions studied: Osteoarthritis of the Knee

In brief

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 .

Key facts

Study ID: NCT02079493
Run by: Tufts Medical Center
People needed: 40
Starts: 2014-01-01
Expected to finish: 2015-05-01
Last updated by the study team: 2019-08-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

Tufts Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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