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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01379118

Acronym

TKR

Enrollment

Registered

2011-06-23

Start date

2012-07-31

Completion date

2016-04-30

Last updated

2016-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Connective Tissue Disorder, Degenerative Joint Disease, Knee Injury, Trauma, Loss of Function, Osteoarthritis, Pain

Keywords

Total knee replacement

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Comparison of Clinical Outcomes and Performance of Total Knee Replacement Patient before and after surgery	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.

Countries

United States

Outcome results