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

Pain Clinical Trial

— TKR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01379118
• Other study ID #: 5110158
• Status: Completed
• Phase: N/A
• First received: June 21, 2011
• Last updated: September 14, 2016
• Start date: July 2012
• Est. completion date: April 2016

Study information

• Verified date: September 2016
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Loma Linda University Healthcare, Deptartment of Orthopaedic Surgery	San Bernardino	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Clinical Outcomes and Performance of Total Knee Replacement Patient before and after surgery	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.	36 months	No