Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00222300




Registration number
NCT00222300
Ethics application status
Date submitted
13/09/2005
Date registered
22/09/2005
Date last updated
8/08/2006

Titles & IDs
Public title
A Targeted Strengthening Program Following Total Hip Replacement.
Scientific title
A Targeted Strengthening Program Following Total Hip Replacement.
Secondary ID [1] 0 0
H2002/01532
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Hip Joint Replacement 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Lower limb strength using a step test
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Pain, stiffness and function using the WOMAC questionnaire.
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Function using the Timed Up-and-Go Test.
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Quality of life using the AQoL
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Spatiotemporal measures of walking using an instrumented mat.
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Hip joint torques using 3-D motion analysis.
Timepoint [5] 0 0

Eligibility
Key inclusion criteria
* primary uncomplicated total hip joint replacement 6-8 weeks prior to enrolment.
* able to walk 45m independently with or without walking aid.
* able to comprehend instructions
* prior joint replacement on the other side at least 12 months previously
Minimum age
0 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* unable to fully weight-bear on affected limb
* pre-existing neurological or orthopaedic condition affecting gait
* revision surgery
* post-operative complications, e.g. wound infection
* uncontrolled systemic disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Health - Melbourne
Recruitment postcode(s) [1] 0 0
3084 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Total Hip Replacement (THR) is a common surgical procedure performed in people with hip osteoarthritis and appears to be effective in relieving pain and improving function. However significant wasting and weakness of the hip and knee muscles persists post-operatively. Although relief of pain and improvement of function are important outcomes following THR, weakness of the hip and knee muscles reduces a person's ability to manage stairs, slopes, public transport and results in persistent gait abnormalities. Since lower limb weakness is one of the risk factors for falls, it is important that patients undergo a strengthening program post-operatively. The hypothesis is that lower limb strength and function will be better in patients who undergo a strengthening program post-operatively than in those who have usual care.
Trial website
https://clinicaltrials.gov/study/NCT00222300
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mary P Galea, PhD
Address 0 0
University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00222300