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| Sponsored by: |
Hadassah Medical Organization |
| Information provided by: | Hadassah Medical Organization |
| ClinicalTrials.gov Identifier: | NCT00256958 |
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 |
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Osteoarthritis Total Knee Replacement |
Procedure: total knee replacement |
Phase I Phase II |
| MedlinePlus related topics: | Knee Replacement Osteoarthritis |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Randomized, Open Label, Historical Control, Single Group Assignment |
| Official Title: | Static and Dynamic Balance During Standing and Walking in Correlation With Quality of Life, in Primary Total Knee Replacement |
| Estimated Enrollment: | 150 |
| Study Start Date: | November 2005 |
| Estimated Study Completion Date: | June 2007 |
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | 50 Years to 90 Years |
| Genders Eligible for Study: | Both |
| 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.
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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.
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Contacts and Locations| Contact: Isabella Schwartz, MD | 972-25844474 | isabellas@hadassah.org.il |
| 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 | |||||
| Hadassah Medical Organization |
| Principal Investigator: | Isabella Schwartz, MD | Hadassah Medical Organization |
More Information
| Study ID Numbers: | TKR-BM-HMO-CTIL |
| First Received: | November 20, 2005 |
| Last Updated: | May 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00256958 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
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