Comparison of Clinical Outcomes and Performance of Total Knee Replacement Patients Before and After Surgery (TKR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01379118|
Recruitment Status : Completed
First Posted : June 23, 2011
Last Update Posted : September 15, 2016
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.
|Condition or disease|
|Degenerative Joint Disease Osteoarthritis Knee Injury, Trauma Connective Tissue Disorder Pain Loss of Function|
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.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Observational Model:||Case Control|
|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|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||April 2016|
- Comparison of Clinical Outcomes and Performance of Total Knee Replacement Patient before and after surgery [ Time Frame: 36 months ]To determine the relevancy of clinical scales for outcome measures as compared to flexion angle and other gait measures. Clinical measures in the form of the Knee Society Score and the WOMAC Score will be obtained from patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01379118
|United States, California|
|Loma Linda University Healthcare, Deptartment of Orthopaedic Surgery|
|San Bernardino, California, United States, 92408|
|Principal Investigator:||Gary D. Botimer, M.D.||Loma Linda University Medical Center|