Pain Clinical Trial
Official title:
Comparison of Clinical Scales and Quantitative Knee Motion Data in Assessing the Clinical Outcomes and Performance of Total Knee Replacement Patients Before and After Surgery
This study is to determine the relevancy of clinical scales for outcome measures as compared
to flexion angle and other gait measures. Clinical outcomes measures in the form of the Knee
Society Score and the WOMAC Score will be obtained from patients. Gait data will also be
obtained from total knee replacement (TKR) patients at pre-operative and post-operative
times. Gait data will be measured on unaffected normal controls as a second baseline.
The hypothesis is that the subjects clinical outcome measures do not accurately reflect gait
dependent outcomes amd functional performance of the total knee replacement.
Patients scheduled to undergo unilateral total knee replacement (TKR) surgery will be the
subjects of the study. A control group of Healthy volunteers, will serve as a control group.
The control group will be matched as close as possible by age and gender to the TKR group.
Both pre and post-operative (3 weeks, 6, 9 and 12 months follow-up) measurements will be
performed on the TKR group.
A Intelligent Device for Energy Expenditure and Activity (IDEEA) will be used to record body
motion, the sensors for the IDEEA device will be placed on the patient and secured with
adhesive tape(if not allergic) once the IDEEA device is properly placed on the patient,
measuring and calibrating can start.
The patient will be required to perform tasks, walking at a normal pace for approximately
100 feet on a level surface, walk up and down moderate incline ramp, climb stairs 7 to 8
steps, sit and rise from two chairs. Parameters will be measured on each subject, knee
flexion angle( walking, stair climbing and sitting), velocity ( walking and stair climbing),
Stride length (walking), Energy (walking, stair climbing, and sitting), other parameters
will be added as needed.
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Observational Model: Case Control, Time Perspective: Prospective
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