Osteoarthritis of the KneePhase 3MRC KneeNCT00562822
Surgery Versus No Surgery for Osteoarthritis (OA) of the Knee
A Phase 3 study testing Arthroscopic surgery and Physical and medical therapy in people with Osteoarthritis of the Knee, run by University of Western Ontario, Canada at 1 site in Canada.
Trial summary
The purpose of this study is to discover whether arthroscopic surgery is helpful in controlling the symptoms of osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Arthroscopic surgery and Physical and medical therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteCanada
- Study dates
- Jan 1999to Aug 2007
- Phase
- Phase 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic or secondary osteoarthritis of the knee with Grade II to IV radiographic severity as defined by the modified Kellgren and Lawrence classification
Who cannot join
- Patients with inflammatory or post-infectious arthritis
- Those who had undergone previous arthroscopic treatment for knee osteoarthritis
- Those with isolate Grade III to IV medical compartment osteoarthritis with greater than 5 degrees of varus deformity.
Trial locations and contacts
1 site in 1 country.
Canada1 site
London Health Sciences Centre - University Hospital
London, Ontario, N6A 5A5
About this study
Official title: Arthroscopic vs. Non-surgical Treatment of Osteoarthritis of the Knee
The purpose of this study is to discover whether arthroscopic surgery is helpful in controlling the symptoms of osteoarthritis of the knee.
Read the detailed description
Although arthroscopic surgery has been widely used for osteoarthritis of the knee, scientific evidence to support its efficacy is lacking. This study will compare optimized physical and medical therapy alone with arthroscopic treatment in addition to optimized physical and medical therapy.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Arthroscopic surgery, Physical and medical therapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic surgeryProcedure or surgery
Arthroscopic surgery to treat unresolved symptoms of osteoarthritis of the knee
Physical and medical therapyOther
Treatment with physical and medical therapy alone
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic Surgery | Active comparator | Arthroscopic surgery optimized with physical and medical therapy Receives: Procedure: Arthroscopic surgery; Other: Physical and medical therapy |
| Physical and medical therapy | Active comparator | treatment with physical and medical therapy alone Receives: Other: Physical and medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Function, pain and quality of life based on the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) scores
Measured: 2 years
Secondary outcomes (1)
Health utility using the Standard Gamble Technique
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2007 (estimated)
- Study startJan 1999
- Primary completionAug 2007
- Study completionAug 2007
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 Osteoarthritis of the KneeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Western Ontario, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Peter J Fowler, MD, Principal investigator, Western University, CanadaBrian G Feagan, MD, Study chair, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00562822
- Sponsor's protocol ID
- mrc123456
- Other IDs
- MCT-15227
- Acronym
- MRC Knee
- Status last verified
- May 2014
- First submitted
- 20 Nov 2007
- Last updated
- 22 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Moseley JB, O'Malley K, Petersen NJ, Menke TJ, Brody BA, Kuykendall DH, Hollingsworth JC, Ashton CM, Wray NP. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2002 Jul 11;347(2):81-8. doi: 10.1056/NEJMoa013259.
PubMed 12110735
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic vs. Non-surgical Treatment of Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT00562822
- Acronym / sponsor ID
- MRC Knee / mrc123456
- Conditions
- Osteoarthritis of the Knee
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- University of Western Ontario, CanadaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jan 1999
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 22 Nov 2007 (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.
The purpose of this study is to discover whether arthroscopic surgery is helpful in controlling the symptoms of osteoarthritis of the knee.
Detailed description
Although arthroscopic surgery has been widely used for osteoarthritis of the knee, scientific evidence to support its efficacy is lacking. This study will compare optimized physical and medical therapy alone with arthroscopic treatment in addition to optimized physical and medical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic Surgery | Active comparator | Procedure: Arthroscopic surgery, Other: Physical and medical therapyArthroscopic surgery optimized with physical and medical therapy |
| Physical and medical therapy | Active comparator | Other: Physical and medical therapytreatment with physical and medical therapy alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Idiopathic or secondary osteoarthritis of the knee with Grade II to IV radiographic severity as defined by the modified Kellgren and Lawrence classification
Key exclusion criteria (3 listed)
- Patients with inflammatory or post-infectious arthritis
- Those who had undergone previous arthroscopic treatment for knee osteoarthritis
- Those with isolate Grade III to IV medical compartment osteoarthritis with greater than 5 degrees of varus deformity.
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 |
|---|---|---|
| Arthroscopic surgeryArthroscopic surgery to treat unresolved symptoms of osteoarthritis of the knee | Procedure or surgery | Arthroscopic Surgery |
| Physical and medical therapyTreatment with physical and medical therapy alone | Other | Arthroscopic Surgery, Physical and medical therapy |
Primary outcome
Function, pain and quality of life based on the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) scores
Time frame: 2 years
1 secondary outcome
Health utility using the Standard Gamble Technique
Time frame: 24 months
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 May 2014.
- Background: PubMed 12110735Moseley JB, O'Malley K, Petersen NJ, Menke TJ, Brody BA, Kuykendall DH, Hollingsworth JC, Ashton CM, Wray NP. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2002 Jul 11;347(2):81-8. doi: 10.1056/NEJMoa013259.
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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.
Peter J Fowler, MD principal investigator
Western University, Canada
Brian G Feagan, MD study chair
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Arthroscopic surgery and Physical and medical therapy in people with Osteoarthritis of the Knee, run by University of Western Ontario, Canada at 1 site in Canada.
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 1 inclusion and 3 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 May 2014. 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 Canada. 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 phase mean?
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?
Function, pain and quality of life based on the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) scores (time frame: 2 years). 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 NCT00562822, 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 May 2014.