NCT00256958

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2005

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

May 13, 2008

Status Verified

November 1, 2005

First QC Date

November 20, 2005

Last Update Submit

May 12, 2008

Conditions

Outcome Measures

Primary Outcomes (5)

  • Balance Master Testing

  • Oxford Knee Score

  • Visual Analog Scale

  • Four Square Step Test

  • Time Up and Go test

Secondary Outcomes (1)

  • SF-36.

Interventions

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Isabella Schwartz, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabella Schwartz, MD

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 20, 2005

First Posted

November 22, 2005

Study Start

November 1, 2005

Study Completion

June 1, 2007

Last Updated

May 13, 2008

Record last verified: 2005-11

Locations