Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000116325
Ethics application status
Not yet submitted
Date submitted
28/02/2008
Date registered
29/02/2008
Date last updated
29/02/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Gait, balance and falls risk in people with knee osteoarthritis before and after knee replacement surgery
Scientific title
Gait, balance and falls risk in people with knee osteoarthritis before and after knee replacement surgery
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
knee osteoarthritis 2891 0
knee replacement surgery 2892 0
Condition category
Condition code
Surgery 3028 3028 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
participants with end stage of knee osteoarthritis (on a waiting list for knee surgery) will be assessed before undergoing knee replacement surgery and after knee replacement surgery for a follow up of 1 year.
Intervention code [1] 2622 0
Treatment: Surgery
Comparator / control treatment
none
Control group
Active

Outcomes
Primary outcome [1] 3906 0
Falls risk.
The falls risk will be assessed using a series of tests of physiological function (the Physiological Profile Assessment). The assessment includes tests of vision (edge contrast sensitivity, visual acuity), peripheral sensation (a lower limb matching task for determining position sense), lower limb strength (knee extension strength), reaction time, and balance (sway when standing on a medium density foam rubber mat).
Timepoint [1] 3906 0
Before knee replacement surgery and at 4 and 12 months after the surgery.
Primary outcome [2] 3907 0
Gait.
Swing limb kinematics and kinetic, toe clearance and foot function will be assessed during walking using three dimensional motion analysis system and force platforms.
Timepoint [2] 3907 0
Before knee replacement surgery and at 4 and 12 months after the surgery.
Secondary outcome [1] 6584 0
Quality of life, pain and knee function.
The quality of life of the participants will be measured using the Assessment of Quality of Life (AQoL) utility instrument, a self-administered health-related questionnaire on quality of life.
The self-reported physical function and pain of the participants will be assessed using the Western Ontario and McMasters University Osteoarthritis Index (WOMAC).
Timepoint [1] 6584 0
Before knee replacement surgery and at 4 and 12 months after the surgery.

Eligibility
Key inclusion criteria
patients with diagnosed unilateral or bilateral medial compartment knee OA (on a waiting list for knee replacement) aged 50 and over (of either gender)
Minimum age
18 Years
Maximum age
95 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they had uncontrolled systemic disease, previous knee surgery and a pre-existing neurological or other orthopaedic condition affecting walking. Participants will be also excluded from the study if they have had the following foot conditions: partial foot amputation or ulceration, foot fractures, any neurological condition that affects lower limb strength (eg: stroke, polio), or any other musculoskeletal conditions which may affect the foot (eg: rheumatoid arthritis, gout).

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
longitudinal study
participants from the control group will be age and gender matched to the osteoarthritis group
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 782 0
3086

Funding & Sponsors
Funding source category [1] 3141 0
Charities/Societies/Foundations
Name [1] 3141 0
Arthritis Australia
Country [1] 3141 0
Australia
Primary sponsor type
University
Name
Musculoskeletal Research Centre, La Trobe University
Address
Musculoskeletal Research Centre

Faculty of Health Sciences, La Trobe University

Bundoora, Victoria 3086, Australia
Country
Australia
Secondary sponsor category [1] 2821 0
None
Name [1] 2821 0
Address [1] 2821 0
Country [1] 2821 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 5111 0
Ethics committee address [1] 5111 0
Ethics committee country [1] 5111 0
Australia
Date submitted for ethics approval [1] 5111 0
01/02/2008
Approval date [1] 5111 0
Ethics approval number [1] 5111 0
Ethics committee name [2] 5113 0
Ethics committee address [2] 5113 0
Ethics committee country [2] 5113 0
Date submitted for ethics approval [2] 5113 0
01/02/2008
Approval date [2] 5113 0
Ethics approval number [2] 5113 0

Summary
Brief summary
Falls are among the most common cause of injury and hospital admissions in older people in Australia, and due to the ageing of the population, are a major public health concern. The detection of factors associated with falls may allow clinicians and professionals to implement effective falls prevention programs targeted to those at greatest risk, such as older people with knee osteoarthritis (knee OA). This study will assess the falls risk of individuals with knee osteoarthritis before and at 4 and 12 months following knee replacement surgery using the a series of validated tests (the Physiological Profile Assessment). Additionally, this study will investigate walking patterns (including the minimum foot clearance and the swing limb kinematics and kinetics) in patients with knee osteoarthritis (prior to undergoing knee replacement and 4 and 12 months following surgery) and compare them to an asymptomatic age-matched control group. As such this study will identify the balance and gait characteristics that may predispose older people with knee osteoarthritis to tripping and falling.

The research hypotheses are:

(i) Patients with knee osteoarthritis will demonstrate different falls risk before and after knee replacement.

(ii) Patients with knee osteoarthritis will demonstrate altered minimum toe clearance and swing limb mechanics compared to age matched controls.

(iii) Patients with knee osteoarthritis will show different minimum toe clearance and swing limb biomechanics before and after knee replacement surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28414 0
Address 28414 0
Country 28414 0
Phone 28414 0
Fax 28414 0
Email 28414 0
Contact person for public queries
Name 11571 0
Dr Pazit Levinger
Address 11571 0
Musculoskeletal Research Centre

Faculty of Health Sciences, La Trobe University

Bundoora, Victoria 3086, Australia
Country 11571 0
Australia
Phone 11571 0
03-94795260
Fax 11571 0
Email 11571 0
[email protected]
Contact person for scientific queries
Name 2499 0
Dr Pazit Levinger
Address 2499 0
Musculoskeletal Research Centre

Faculty of Health Sciences, La Trobe University

Bundoora, Victoria 3086, Australia
Country 2499 0
Australia
Phone 2499 0
03-94795260
Fax 2499 0
Email 2499 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.