OsteoarthritisPhase 3NCT00158431
Surgery Versus no Surgery for OA of the Knee
A Phase 3 study testing Arthroscopy plus Medical Management and Medical Management in people with Osteoarthritis, run by Fowler Kennedy Sport Medicine Clinic at 1 site in Canada.
Trial summary
The purpose of this trial is to evaluate the effectiveness of arthroscopy (lavage and debridement) in conjunction with the best available non-surgical treatment versus the best available non-surgical treatment alone (medication, health education and physical therapy) in patients with osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Arthroscopy plus Medical Management and Medical Management
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 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 as diagnosed by Altman et al 2 classification tree -83 percent sensitivity, 93percent specificity
- Grades 2 to 4 severity of OA by radiographic evaluation- modified Kellgren and Lawrence grading system
- Age greater than 18.
Who cannot join
- Inflammatory or post-infection arthritis of the knee
- Previous arthroscopy for treatment of knee OA
- Isolated medial compartment OA Grade 3-4 with greater than 5 degrees mechanical varus -ideal candidate for high tibial osteotomy
- Isolated lateral compartment OA Grade III-IV with greater than 5 degrees mechanical valgus -ideal candidate for high tibial osteotomy or distal femoral osteotomy
- Grade 4 OA in at least 2 compartments and over 60 years of age -ideal candidate for total knee arthroplasty
- Cortico-steroid injection within the last three months.
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- Major neurological deficit
- Major medical illness -life expectancy less than 2 years or with unacceptably high operative risk.
- Pregnant
- Unable to speak or read English
- Psychiatric illness that limits informed consent
- Unwilling to be followed for 2 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arthroscopic Surgery Versus Non-surgical Treatment of Osteoarthritis of the Knee
The purpose of this trial is to evaluate the effectiveness of arthroscopy (lavage and debridement) in conjunction with the best available non-surgical treatment versus the best available non-surgical treatment alone (medication, health education and physical therapy) in patients with osteoarthritis of the knee.
Read the detailed description
Osteoarthritis is estimated to affect half of the adult population, and by the age of 75 years, it is anticipated that 85 of 100 elderly patients will have some form of this disease. Osteoarthritis (OA) is characterized by moderate to severe pain that limits functional ability. It is suspected that the causes of this debilitating pain include irritation of the synovium, excessive subchondral bone forces and raised intra-arterial pressure. The knee is the most commonly affected weight-bearing joint. Osteoarthritis has a great social impact, as the second most common reason for work disability in the United States. The prevalence of OA is expected to increase in the coming years due to increased longevity, increased proportion of the population over the age of 75 years, and increased diagnostic ability.
Rather than further evaluations of different forms of arthroscopic surgery (ie lavage vs debridement vs abrasion) in the treatment of knee OA, we feel it is important to establish the efficacy of this technology compared to the best non-surgical treatment alone.
This is an evaluator- blinded, phase III, single-centre, group sequential randomized controlled trial in patients with osteoarthritis of the knee.
Treatment effectiveness is based upon patients' disease specific quality of life at 2 years using the Western Ontario McMaster (WOMAC) Osteoarthritis Index. In addition patients' physical function and cost effectiveness are being assessed. Costs will be estimated from the perspectives of the health care system, the patient,family, and society and will include the use of hospital and other resources as well as the economic implications of lost workdays associated with these alternative treatments.
This randomized clinical trial will provide high quality evidence to determine what the role of this expensive treatment is in the overall management of OA.
- Conditions
- Osteoarthritis
- Being tested
- Arthroscopy plus Medical Management, Medical Management
- Keywords
- osteoarthritis, randomized trial, knee, quality of life
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopy plus Medical ManagementProcedure or surgery
Arthroscopic Surgery
Medical ManagementOther
education, optimized medication, weight loss where needed, HA or cortisone injections if needed, physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopy plus Medical Management | Active comparator | Arthroscopic Surgery of the Knee plus the optimized medical management including physiotherapy, education, medication, etc Receives: Procedure: Arthroscopy plus Medical Management; Other: Medical Management |
| Medical Management | No intervention | Optimized Medical management including physiotherapy, education, medication, etc |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare between the two treatment groups the patients' disease-specific quality of life at 2 years using the Western Ontario McMaster (WOMAC) osteoarthritis index and
Measured: 2 years
Secondary outcomes (1)
SF-36,Mactar, Arthritis Self-Efficacy Scale, Standard Gamble Utility Measure
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (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 (54)Papers the sponsor has linked to this study.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fowler Kennedy Sport Medicine Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Sharon Griffin, Fowler Kennedy Sport Medicine Clinic
- Investigators
- Peter J Fowler, MD, FRCSC, Principal investigator, Fowler Kennedy Sport Medicine Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00158431
- Sponsor's protocol ID
- FKSMC-CIHR-1
- Other IDs
- CIHR MCT-15227
- Status last verified
- Nov 2015
- First submitted
- 7 Sep 2005
- Last updated
- 30 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Altman RD, Fries JF, Bloch DA, Carstens J, Cooke TD, Genant H, Gofton P, Groth H, McShane DJ, Murphy WA, et al. Radiographic assessment of progression in osteoarthritis. Arthritis Rheum. 1987 Nov;30(11):1214-25. doi: 10.1002/art.1780301103.
PubMed 3689459Baumgaertner MR, Cannon WD Jr, Vittori JM, Schmidt ES, Maurer RC. Arthroscopic debridement of the arthritic knee. Clin Orthop Relat Res. 1990 Apr;(253):197-202.
PubMed 2317974Bert JM. Role of abrasion arthroplasty and debridement in the management of osteoarthritis of the knee. Rheum Dis Clin North Am. 1993 Aug;19(3):725-39.
PubMed 8210584Blackburn WD Jr, Bernreuter WK, Rominger M, Loose LL. Arthroscopic evaluation of knee articular cartilage: a comparison with plain radiographs and magnetic resonance imaging. J Rheumatol. 1994 Apr;21(4):675-9.
PubMed 8035392Brandt KD. Should osteoarthritis be treated with nonsteroidal anti-inflammatory drugs? Rheum Dis Clin North Am. 1993 Aug;19(3):697-712.
PubMed 8210582Brandt KD, Fife RS, Braunstein EM, Katz B. Radiographic grading of the severity of knee osteoarthritis: relation of the Kellgren and Lawrence grade to a grade based on joint space narrowing, and correlation with arthroscopic evidence of articular cartilage degeneration. Arthritis Rheum. 1991 Nov;34(11):1381-6. doi: 10.1002/art.1780341106.
PubMed 1953815Brief AA, Maurer SG, Di Cesare PE. Use of glucosamine and chondroitin sulfate in the management of osteoarthritis. J Am Acad Orthop Surg. 2001 Mar-Apr;9(2):71-8. doi: 10.5435/00124635-200103000-00001.
PubMed 11281631Burks RT. Arthroscopy and degenerative arthritis of the knee: a review of the literature. Arthroscopy. 1990;6(1):43-7. doi: 10.1016/0749-8063(90)90096-v. No abstract available.
PubMed 2178619Chandler EJ. Abrasion arthroplasty of the knee. Contemporary Orthopaedics; 1121-1985
Chang RW, Falconer J, Stulberg SD, Arnold WJ, Manheim LM, Dyer AR. A randomized, controlled trial of arthroscopic surgery versus closed-needle joint lavage for patients with osteoarthritis of the knee. Arthritis Rheum. 1993 Mar;36(3):289-96. doi: 10.1002/art.1780360302.
PubMed 8452573Deyle GD, Henderson NE, Matekel RL, Ryder MG, Garber MB, Allison SC. Effectiveness of manual physical therapy and exercise in osteoarthritis of the knee. A randomized, controlled trial. Ann Intern Med. 2000 Feb 1;132(3):173-81. doi: 10.7326/0003-4819-132-3-200002010-00002.
PubMed 10651597Dieppe P, Cushnaghan J, Jasani MK, McCrae F, Watt I. A two-year, placebo-controlled trial of non-steroidal anti-inflammatory therapy in osteoarthritis of the knee joint. Br J Rheumatol. 1993 Jul;32(7):595-600. doi: 10.1093/rheumatology/32.7.595.
PubMed 8339132Edelson R, Burks RT, Bloebaum RD. Short-term effects of knee washout for osteoarthritis. Am J Sports Med. 1995 May-Jun;23(3):345-9. doi: 10.1177/036354659502300317.
PubMed 7661265Felson DT, Zhang Y, Anthony JM, Naimark A, Anderson JJ. Weight loss reduces the risk for symptomatic knee osteoarthritis in women. The Framingham Study. Ann Intern Med. 1992 Apr 1;116(7):535-9. doi: 10.7326/0003-4819-116-7-535.
PubMed 1543306Fife RS, Brandt KD, Braunstein EM, Katz BP, Shelbourne KD, Kalasinski LA, Ryan S. Relationship between arthroscopic evidence of cartilage damage and radiographic evidence of joint space narrowing in early osteoarthritis of the knee. Arthritis Rheum. 1991 Apr;34(4):377-82. doi: 10.1002/art.1780340402.
PubMed 2012624
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Surgery Versus Non-surgical Treatment of Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT00158431
- Acronym / sponsor ID
- FKSMC-CIHR-1
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis, randomized trial, knee, quality of life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Fowler Kennedy Sport Medicine ClinicUniversity, 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
- 12 Sep 2005 (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 trial is to evaluate the effectiveness of arthroscopy (lavage and debridement) in conjunction with the best available non-surgical treatment versus the best available non-surgical treatment alone (medication, health education and physical therapy) in patients with osteoarthritis of the knee.
Detailed description
Osteoarthritis is estimated to affect half of the adult population, and by the age of 75 years, it is anticipated that 85 of 100 elderly patients will have some form of this disease. Osteoarthritis (OA) is characterized by moderate to severe pain that limits functional ability. It is suspected that the causes of this debilitating pain include irritation of the synovium, excessive subchondral bone forces and raised intra-arterial pressure. The knee is the most commonly affected weight-bearing joint. Osteoarthritis has a great social impact, as the second most common reason for work disability in the United States. The prevalence of OA is expected to increase in the coming years due to increased longevity, increased proportion of the population over the age of 75 years, and increased diagnostic ability.
Rather than further evaluations of different forms of arthroscopic surgery (ie lavage vs debridement vs abrasion) in the treatment of knee OA, we feel it is important to establish the efficacy of this technology compared to the best non-surgical treatment alone.
This is an evaluator- blinded, phase III, single-centre, group sequential randomized controlled trial in patients with osteoarthritis of the knee.
Treatment effectiveness is based upon patients' disease specific quality of life at 2 years using the Western Ontario McMaster (WOMAC) Osteoarthritis Index. In addition patients' physical function and cost effectiveness are being assessed. Costs will be estimated from the perspectives of the health care system, the patient,family, and society and will include the use of hospital and other resources as well as the economic implications of lost workdays associated with these alternative treatments.
This randomized clinical trial will provide high quality evidence to determine what the role of this expensive treatment is in the overall management of OA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthroscopy plus Medical Management | Active comparator | Procedure: Arthroscopy plus Medical Management, Other: Medical ManagementArthroscopic Surgery of the Knee plus the optimized medical management including physiotherapy, education, medication, etc |
| Medical Management | No intervention | –Optimized Medical management including physiotherapy, education, medication, etc |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Idiopathic or secondary osteoarthritis of the knee as diagnosed by Altman et al 2 classification tree -83 percent sensitivity, 93percent specificity
- Grades 2 to 4 severity of OA by radiographic evaluation- modified Kellgren and Lawrence grading system
- Age greater than 18.
Key exclusion criteria (12 listed)
- Inflammatory or post-infection arthritis of the knee
- Previous arthroscopy for treatment of knee OA
- Isolated medial compartment OA Grade 3-4 with greater than 5 degrees mechanical varus -ideal candidate for high tibial osteotomy
- Isolated lateral compartment OA Grade III-IV with greater than 5 degrees mechanical valgus -ideal candidate for high tibial osteotomy or distal femoral osteotomy
- Grade 4 OA in at least 2 compartments and over 60 years of age -ideal candidate for total knee arthroplasty
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 |
|---|---|---|
| Arthroscopy plus Medical ManagementArthroscopic Surgery | Procedure or surgery | Arthroscopy plus Medical Management |
| Medical Managementeducation, optimized medication, weight loss where needed, HA or cortisone injections if needed, physiotherapy | Other | Arthroscopy plus Medical Management |
Primary outcome
To compare between the two treatment groups the patients' disease-specific quality of life at 2 years using the Western Ontario McMaster (WOMAC) osteoarthritis index and
Time frame: 2 years
1 secondary outcome
SF-36,Mactar, Arthritis Self-Efficacy Scale, Standard Gamble Utility Measure
Time frame: 2 years
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 30 Nov 2015.
- Background: PubMed 3689459Altman RD, Fries JF, Bloch DA, Carstens J, Cooke TD, Genant H, Gofton P, Groth H, McShane DJ, Murphy WA, et al. Radiographic assessment of progression in osteoarthritis. Arthritis Rheum. 1987 Nov;30(11):1214-25. doi: 10.1002/art.1780301103.
- Background: PubMed 2317974Baumgaertner MR, Cannon WD Jr, Vittori JM, Schmidt ES, Maurer RC. Arthroscopic debridement of the arthritic knee. Clin Orthop Relat Res. 1990 Apr;(253):197-202.
- Background: PubMed 8210584Bert JM. Role of abrasion arthroplasty and debridement in the management of osteoarthritis of the knee. Rheum Dis Clin North Am. 1993 Aug;19(3):725-39.
- Background: PubMed 8035392Blackburn WD Jr, Bernreuter WK, Rominger M, Loose LL. Arthroscopic evaluation of knee articular cartilage: a comparison with plain radiographs and magnetic resonance imaging. J Rheumatol. 1994 Apr;21(4):675-9.
- Background: PubMed 8210582Brandt KD. Should osteoarthritis be treated with nonsteroidal anti-inflammatory drugs? Rheum Dis Clin North Am. 1993 Aug;19(3):697-712.
- Background: PubMed 1953815Brandt KD, Fife RS, Braunstein EM, Katz B. Radiographic grading of the severity of knee osteoarthritis: relation of the Kellgren and Lawrence grade to a grade based on joint space narrowing, and correlation with arthroscopic evidence of articular cartilage degeneration. Arthritis Rheum. 1991 Nov;34(11):1381-6. doi: 10.1002/art.1780341106.
- Background: PubMed 11281631Brief AA, Maurer SG, Di Cesare PE. Use of glucosamine and chondroitin sulfate in the management of osteoarthritis. J Am Acad Orthop Surg. 2001 Mar-Apr;9(2):71-8. doi: 10.5435/00124635-200103000-00001.
- Background: PubMed 2178619Burks RT. Arthroscopy and degenerative arthritis of the knee: a review of the literature. Arthroscopy. 1990;6(1):43-7. doi: 10.1016/0749-8063(90)90096-v. No abstract available.
- BackgroundChandler EJ. Abrasion arthroplasty of the knee. Contemporary Orthopaedics; 1121-1985
- Background: PubMed 8452573Chang RW, Falconer J, Stulberg SD, Arnold WJ, Manheim LM, Dyer AR. A randomized, controlled trial of arthroscopic surgery versus closed-needle joint lavage for patients with osteoarthritis of the knee. Arthritis Rheum. 1993 Mar;36(3):289-96. doi: 10.1002/art.1780360302.
- Background: PubMed 10651597Deyle GD, Henderson NE, Matekel RL, Ryder MG, Garber MB, Allison SC. Effectiveness of manual physical therapy and exercise in osteoarthritis of the knee. A randomized, controlled trial. Ann Intern Med. 2000 Feb 1;132(3):173-81. doi: 10.7326/0003-4819-132-3-200002010-00002.
- Background: PubMed 8339132Dieppe P, Cushnaghan J, Jasani MK, McCrae F, Watt I. A two-year, placebo-controlled trial of non-steroidal anti-inflammatory therapy in osteoarthritis of the knee joint. Br J Rheumatol. 1993 Jul;32(7):595-600. doi: 10.1093/rheumatology/32.7.595.
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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, FRCSC principal investigator
Fowler Kennedy Sport Medicine Clinic
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 Arthroscopy plus Medical Management and Medical Management in people with Osteoarthritis, run by Fowler Kennedy Sport Medicine Clinic 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 3 inclusion and 12 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 30 Nov 2015. 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?
To compare between the two treatment groups the patients' disease-specific quality of life at 2 years using the Western Ontario McMaster (WOMAC) osteoarthritis index and (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 NCT00158431, which also lists 54 linked publications.
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 30 Nov 2015.