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Static and Dynamic Balance in Correlation With Quality of Life, in Primary Total Knee Replacement

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2005 by Hadassah Medical Organization.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00256958
First Posted: November 22, 2005
Last Update Posted: May 13, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization
  Purpose

Knee osteoarthritis (OA) is one of the most prevalent musculoskeletal complaints worldwide, affecting 30-40% of the population by the age of 65 yr.Individuals with knee OA suffer progressive loss of function.Balance is an integral component of these and many other activities of daily living. Individuals with knee OA display impairment in postural control, mostly under dynamic testing condition. Total knee replacement (TKR) has an established place in the treatment of knee osteoarthritis and is considered to be an effective intervention.It remains unknown whether TKR impact significantly at balance state of the patients with OA and whether improving in functional abilities after TKR correlates with balance control ability in this population.The purpose of this study is to determine whether TKR have any effects on relatively new postural control measures using force platform system - Balance master, in correlation with functional balance assessment.

Methods:

Participants During a year of prospective study we plan to recruit 150 participants with symptomatic OA of the knee, hospitalizing in orthopedic department of Hadassah Hospital for primary TKR. Participants will undergo evaluation just before a surgery and a year after.They will be asked to perform Balance Master measurements, ambulation and balance tests. Additional information will be collected through a questionnaire and physical examination.


Condition Intervention Phase
Osteoarthritis Total Knee Replacement Procedure: total knee replacement Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Static and Dynamic Balance During Standing and Walking in Correlation With Quality of Life, in Primary Total Knee Replacement

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Balance Master Testing
  • Oxford Knee Score
  • Visual Analog Scale
  • Four Square Step Test
  • Time Up and Go test

Secondary Outcome Measures:
  • SF-36.

Estimated Enrollment: 150
Study Start Date: November 2005
Estimated Study Completion Date: June 2007
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:During a year of prospective study we plan to recruit 150 participants with symptomatic OA of the knee, hospitalizing in orthopedic department of Hadassah Hospital for primary TKR. Confirmation of diagnosis of OA will be based on the American College of Rheumatology classification criteria . Participants have to be able to stand and to walk and also to follow simple instructions.

Exclusion Criteria:previous knee surgery, neurological problem with severe motor deficit (Parkinson disease, hemiplegia, spinal cord injury), severe orthopedic problem of low limbs (arthrodesis of low limb's joints, failed TKR/THR, amputation, failed back), systemic arthritic condition, severe cognitive problem with restricted consent.

  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): NCT00256958


Contacts
Contact: Isabella Schwartz, MD 972-25844474 isabellas@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Recruiting
Jerusalem, Israel
Contact: Arik Tzukert, DMD    00 972 2 6776095    arik@hadassah.org.il   
Contact: Hadas Lemberg, PhD    00 972 2 6777572    lhadas@hadassah.org.il   
Principal Investigator: Isabella Schwartz, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Isabella Schwartz, MD Hadassah Medical Organization
  More Information

ClinicalTrials.gov Identifier: NCT00256958     History of Changes
Other Study ID Numbers: TKR-BM-HMO-CTIL
First Submitted: November 20, 2005
First Posted: November 22, 2005
Last Update Posted: May 13, 2008
Last Verified: November 2005

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases