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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
Information provided by:
Hadassah Medical Organization Identifier:
First received: November 20, 2005
Last updated: May 12, 2008
Last verified: November 2005

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.


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
Total Knee Replacement
Procedure: total knee replacement
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: 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


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

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
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Please refer to this study by its identifier: NCT00256958

Contact: Isabella Schwartz, MD 972-25844474

Hadassah Medical Organization Recruiting
Jerusalem, Israel
Contact: Arik Tzukert, DMD    00 972 2 6776095   
Contact: Hadas Lemberg, PhD    00 972 2 6777572   
Principal Investigator: Isabella Schwartz, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Isabella Schwartz, MD Hadassah Medical Organization
  More Information Identifier: NCT00256958     History of Changes
Other Study ID Numbers: TKR-BM-HMO-CTIL
Study First Received: November 20, 2005
Last Updated: May 12, 2008

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on May 24, 2017