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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00414557




Registration number
NCT00414557
Ethics application status
Date submitted
20/12/2006
Date registered
21/12/2006
Date last updated
22/12/2006

Titles & IDs
Public title
Knee Malalignment and Thigh Muscle Strengthening in Individuals With Medial Knee Arthritis
Scientific title
The Effects of Knee Malalignment and Quadriceps Strengthening on the Adduction Moment in Individuals With Medial Knee Osteoarthritis
Secondary ID [1] 0 0
040850
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Quadriceps strengthening

Treatment: Surgery: Quadriceps strengthening
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adduction moment
Timepoint [1] 0 0
Primary outcome [2] 0 0
Time points: 0 and 13 weeks
Timepoint [2] 0 0
Secondary outcome [1] 0 0
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Numerical rating scales for pain
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Quadriceps and hamstrings strength
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Self-selected walking speed
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Dynamic balance using step test
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Physical function using stair climb test
Timepoint [6] 0 0
Secondary outcome [7] 0 0
Time points: 0 and 13 weeks
Timepoint [7] 0 0

Eligibility
Key inclusion criteria
- Pain in the knee

- Osteophytes on knee x-ray

- Self-reported pain on the inner aspect of the study knee

- Osteophytes in the medial compartment of the knee joint and

- Medial joint space narrowing greater than lateral joint space narrowing on x-ray
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Knee surgery within the previous 6 months

- History of lower limb joint replacements

- Systemic arthritic conditions such as rheumatic or psoriatic arthritis

- Valgus knee deformity (> 5º)

- Inability to walk without the use of walking aids

- Intending to start a lower limb strengthening program in the next 3 months

- Seeking or currently receiving physiotherapy for OA knee

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
Factorial
Other design features
Phase
Phase 2/Phase 3
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
1/05/2004
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
The University of Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
3040 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australian Physiotherapy Research Foundation
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
United Pacific Industries
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
To investigate the effects of quadriceps strengthening on the adductor moment in individuals
with medial knee OA and whether quadriceps strengthening has a different effect on the
adductor moment in individuals with and without knee malalignment
Trial website
https://clinicaltrials.gov/ct2/show/NCT00414557
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kim Bennell, 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/ct2/show/NCT00414557