Expired Study
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San Bernardino, California 92408


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Healthy - needs unilateral total knee replacement Exclusion Criteria: - Active infection - Autoimmune disease/ parkinson's disease - HIV - psychosocial disorders that would preclude accurate evaluation or substance abuse - allergic to - pregnant - active malignancy


Study is Available At:


Original ID:

5110158


NCT ID:

NCT01379118


Secondary ID:


Study Acronym:

TKR


Brief Title:

Comparison of Clinical Outcomes and Performance of Total Knee Replacement Patients Before and After Surgery


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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

40 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Loma Linda University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case Control, Time Perspectiv


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

50


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Gary D. Botimer, M.D.
Principal Investigator
Loma Linda University Medical Center

Study Dates

Start Date:July 2012
Completion Date:April 2016
Completion Type:Actual
Primary Completion Date:March 2016
Primary Completion Type:Actual
Verification Date:September 2016
Last Changed Date:September 14, 2016
First Received Date:June 21, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:Comparison of Clinical Outcomes and Performance of Total Knee Replacement Patient before and after surgery
Time Frame:36 months
Safety Issues:False
Description: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.

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Loma Linda University

Samples and Retentions

Study Population: Male and female patients that are healthy and patients that need a unilateral total knee replacement.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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