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

This study is not yet open for participant recruitment.
Verified June 2011 by Loma Linda University
Sponsor:
Information provided by:
Loma Linda University
ClinicalTrials.gov Identifier:
NCT01379118
First received: June 21, 2011
Last updated: June 22, 2011
Last verified: June 2011
History of Changes
  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.


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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Loma Linda University:

Estimated Enrollment: 50
Study Start Date: July 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01379118

Contacts
Contact: Elisabeth Clarke, CR 909-835-1779 eaclarke@llu.edu

Locations
United States, California
Loma Linda University Healthcare, Deptartment of Orthopaedic Surgery Active, not recruiting
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

No publications provided

Responsible Party: Gary D. Botimer, M.D., Loma Linda University Health Care Deptartment of Orthopaedic Surgery
ClinicalTrials.gov Identifier: NCT01379118     History of Changes
Other Study ID Numbers: 5110158
Study First Received: June 21, 2011
Last Updated: June 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Loma Linda University:
Total knee replacement

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

ClinicalTrials.gov processed this record on May 23, 2013