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

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ClinicalTrials.gov Identifier: NCT01379118
Recruitment Status : Completed
First Posted : June 23, 2011
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


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

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.


Study Design

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case Control
Time Perspective: Prospective
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
Primary Completion Date : March 2016
Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Male and female patients that are healthy and patients that need a unilateral total knee replacement.
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
Contacts and Locations

Information from the National Library of Medicine

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


Locations
United States, California
Loma Linda University Healthcare, Deptartment of Orthopaedic Surgery
San Bernardino, California, United States, 92408
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Gary D. Botimer, M.D. Loma Linda University Medical Center
More Information

Responsible Party: Gary Botimer, M.D. and Chairman, Loma Linda University
ClinicalTrials.gov Identifier: NCT01379118     History of Changes
Other Study ID Numbers: 5110158
First Posted: June 23, 2011    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: September 2016

Keywords provided by Gary Botimer, Loma Linda University:
Total knee replacement

Additional relevant MeSH terms:
Osteoarthritis
Joint Diseases
Knee Injuries
Connective Tissue Diseases
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases
Leg Injuries
Wounds and Injuries