Knee OsteoarthritisPhase 2/3NCT00414557
Knee Malalignment and Thigh Muscle Strengthening in Individuals With Medial Knee Arthritis
A Phase 2/3 study testing Quadriceps strengthening in people with Knee Osteoarthritis, run by University of Melbourne at 1 site in Australia.
Trial 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 Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Quadriceps strengthening
- Type of treatment
- Surgery or procedure
- How many people
- 107 participants
- Where
- 1 siteAustralia
- Study dates
- May 2004to Dec 2006
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Knee Malalignment and Quadriceps Strengthening on the Adduction Moment in Individuals With Medial Knee Osteoarthritis
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
Read the detailed description
Although quadriceps strengthening is the cornerstone of physiotherapy management, recent evidence suggests that high quadriceps strength in patients with malaligned knees may increase OA progression.
This study investigates the effects of quadriceps strengthening on the adduction moment in patients with medial knee OA with and without malalignment. 107 participants with and without varus knee malalignment were recruited and randomised into an exercise or a control group. Participants in the exercise group were taught five quadriceps strengthening exercises by a project physiotherapist to be performed five days a week for twelve weeks at home. The exercises were:
- Quadriceps exercise over fulcrum using ankle weight
- Straight leg raise exercise using ankle weight
- Long arc knee extension exercise in sitting using ankle weight
- Knee extension exercise with isometric hold at 60° knee flexion using ankle weight
- Knee extension exercise with isometric hold at 60° knee flexion using an elastic band.
Each exercise was performed at 2x10 repetitions for the first 2 weeks and 3x10 repetitions thereafter.
Participants visited the physiotherapist 7 times at Week 1, 2, 3, 4, 5, 7 and 10. They were given the ankle weights and elastic band to bring home and instructed about the repetitions and weights to use by the physiotherapist, who also checked and progressed their exercises. The average duration of the physiotherapy sessions was 30 minutes. To monitor compliance, each participant was given an exercise instructions sheet and kept a training diary to record the exercises they had done.
The control group received no intervention.
- Conditions
- Knee Osteoarthritis
- Being tested
- Quadriceps strengthening
- Keywords
- Musculoskeletal diseases, Joint diseases
- Medical subject headings
- Osteoarthritis, Knee, Musculoskeletal Diseases, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadriceps strengtheningProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Adduction moment
Time points: 0 and 13 weeks
Secondary outcomes (7)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire
Numerical rating scales for pain
Quadriceps and hamstrings strength
Self-selected walking speed
Dynamic balance using step test
Physical function using stair climb test
Time points: 0 and 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2006 (estimated)
- Study startMay 2004
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Enrolment
- 107 participants
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Collaborators
- Australian Physiotherapy Research Foundation, United Pacific Industries
- Investigators
- Kim Bennell, PhD, Principal investigator, University of MelbourneRana Hinman, PhD, Principal investigator, University of MelbourneTim Wrigley, MSc, Principal investigator, University of MelbourneBoon W Lim, MSc, Principal investigator, University of MelbourneLeena Sharma, MD, Principal investigator, Northwestern University Medical School, Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00414557
- Sponsor's protocol ID
- 040850
- Status last verified
- Dec 2006
- First submitted
- 20 Dec 2006
- Last updated
- 22 Dec 2006
- Results posted
- No
Publications
Lim BW, Hinman RS, Wrigley TV, Sharma L, Bennell KL. Does knee malalignment mediate the effects of quadriceps strengthening on knee adduction moment, pain, and function in medial knee osteoarthritis? A randomized controlled trial. Arthritis Rheum. 2008 Jul 15;59(7):943-51. doi: 10.1002/art.23823.
PubMed 18576289
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Knee Malalignment and Quadriceps Strengthening on the Adduction Moment in Individuals With Medial Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT00414557
- Acronym / sponsor ID
- 040850
- Conditions
- Knee Osteoarthritis
- Keywords
- Musculoskeletal diseases, Joint diseases
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Collaborators
- Australian Physiotherapy Research Foundation, United Pacific Industries
- Study start
- May 2004
- Study completion
- Dec 2006
- First posted
- 21 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Although quadriceps strengthening is the cornerstone of physiotherapy management, recent evidence suggests that high quadriceps strength in patients with malaligned knees may increase OA progression.
This study investigates the effects of quadriceps strengthening on the adduction moment in patients with medial knee OA with and without malalignment. 107 participants with and without varus knee malalignment were recruited and randomised into an exercise or a control group. Participants in the exercise group were taught five quadriceps strengthening exercises by a project physiotherapist to be performed five days a week for twelve weeks at home. The exercises were:
- Quadriceps exercise over fulcrum using ankle weight
- Straight leg raise exercise using ankle weight
- Long arc knee extension exercise in sitting using ankle weight
- Knee extension exercise with isometric hold at 60° knee flexion using ankle weight
- Knee extension exercise with isometric hold at 60° knee flexion using an elastic band.
Each exercise was performed at 2x10 repetitions for the first 2 weeks and 3x10 repetitions thereafter.
Participants visited the physiotherapist 7 times at Week 1, 2, 3, 4, 5, 7 and 10. They were given the ankle weights and elastic band to bring home and instructed about the repetitions and weights to use by the physiotherapist, who also checked and progressed their exercises. The average duration of the physiotherapy sessions was 30 minutes. To monitor compliance, each participant was given an exercise instructions sheet and kept a training diary to record the exercises they had done.
The control group received no intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quadriceps strengthening | Procedure or surgery | – |
Primary outcome
Adduction moment
Time points: 0 and 13 weeks
7 secondary outcomes
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire
Numerical rating scales for pain
Quadriceps and hamstrings strength
Self-selected walking speed
Dynamic balance using step test
Physical function using stair climb test
Time points: 0 and 13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2006.
- Derived from this study: PubMed 18576289Lim BW, Hinman RS, Wrigley TV, Sharma L, Bennell KL. Does knee malalignment mediate the effects of quadriceps strengthening on knee adduction moment, pain, and function in medial knee osteoarthritis? A randomized controlled trial. Arthritis Rheum. 2008 Jul 15;59(7):943-51. doi: 10.1002/art.23823.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim Bennell, PhD principal investigator
University of Melbourne
Rana Hinman, PhD principal investigator
University of Melbourne
Tim Wrigley, MSc principal investigator
University of Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Quadriceps strengthening in people with Knee Osteoarthritis, run by University of Melbourne at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adduction moment. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00414557, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2006.