The Benefit of Arthroscopic Partial Meniscectomy in Middle-Aged Patients (SLAMSHAM)
|First Received Date ICMJE||December 21, 2010|
|Last Updated Date||November 7, 2016|
|Start Date ICMJE||December 2010|
|Primary Completion Date||November 2015 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||Knee injury and Osteoarthritis Outcome Score - KOOS [ Time Frame: 2 year follow-up ]
The primary outcome at 2 years follow-up will be a self-reported questionnaire, the Knee injury and Osteoarthritis Outcome Score (KOOS), comprising five different subscales:
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01264991 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||The Benefit of Arthroscopic Partial Meniscectomy in Middle-Aged Patients|
|Official Title ICMJE||The Benefit of Arthroscopic Partial Meniscectomy in Middle-Aged Patients - A Double-Blinded Randomized Placebo (Sham) Controlled Multi-Centre Trial|
BACKGROUND Osteoarthritis (OA) is the most common form of arthritis and the knee is one of the most affected joints. The meniscus plays an important role in the development of knee OA. It is unclear whether a degenerative meniscus tear is a risk factor in developing knee OA or a sign of the disease. The standard treatment for a degenerative meniscus tear is an arthroscopic partial meniscectomy (APM). There is strong evidence that this puts the knee at high risk of later developing OA. Earlier studies have shown a significant placebo effect from surgical procedures, in general, and an arthroscopic knee procedure, in particular.
PURPOSE The overall purpose of this study is to gather information that might lead to a reduction in the development of OA in middle-aged patients. The investigators hypothesise that the benefit from an arthroscopic partial meniscectomy is due to the placebo effect measured on self-reported outcomes, and that the meniscectomy contributes to the development of knee OA as seen on radiography.
METHODS The investigators will include 100 patients aged from 35 to 55 years with an MRI-confirmed medial meniscus tear and without knee OA (excluding patients with Grade 3 or 4 knee OA on the Kellgren-Lawrence classification). Participants will be randomised to either a standard APM procedure or a sham procedure and both groups will receive standard post-operative care. The primary outcomes will be a self-reported questionnaire, the KOOS score, and a functionality test after 3 and 24 months.
BACKGROUND Osteoarthritis (OA) is the most common form of arthritis and affects 4.5 % of the Danish population. The knee is one of the most affected joints and 45 % of all OA-related hospital contacts are related to the knee. OA has a long 'pre-clinical' phase with joint changes without symptoms. Then comes a symptomatic phase with pain and functional limitations. This is sometimes accompanied by structural changes visible on plain X-ray examination and other pathological changes like focal areas of damage to the articular cartilage, centered on load-bearing areas. After this, new bone formation at the joint margins (osteophytosis) develops along with changes in the subchondral bone, variable degrees of mild synovitis, and thickening of the joint capsule.
The meniscus plays an important role in the development of osteoarthritis. Meniscus tears can be both a risk factor for knee OA as well as a sign of disease . Both meniscus injury and a meniscectomy contribute to the development of knee OA. The surgical removal of the damaged parts of a meniscus tear puts the knee at high risk of later developing OA . Surgical resection also leads to increased joint cartilage contact stress through altered load transmission, decreased shock absorption, and decreased joint stability .
The current standard treatment for a degenerative meniscus tear is arthroscopic partial meniscectomy (APM). Arthroscopic surgery is one of the most frequent orthopaedic procedures with approximately 10,000 APM procedures being done per year in Denmark .
The benefit from an APM procedure is, however, uncertain and needs to be further investigated. As mentioned above, it significantly increases the risk of developing knee OA. The investigators also know that a significant placebo effect is present in arthroscopic knee surgery including the APM procedure . It has furthermore been shown that patients with a degenerative meniscus tear can recover without surgery and by exercise alone , . The recovery period after an APM procedure is also much longer than most surgeons realize, with disability still evident after 3 months.
The investigators need to investigate the placebo effect in younger patients with a degenerative meniscus tear but without knee OA by implementing additional well-designed, randomized, placebo controlled trials to reveal the true effects of the APM procedure on a short-and long-term basis.
The benefit, on a short- and long term basis of APM are firstly described in non-controlled studies from the 1980-90's. , , when arthroscopic surgery were gaining entry. But poorly designed studies (retrospective, use of non-validated outcome scores, small patient populations) and the lack of randomised studies has not shown the true effect of the APM procedure. A Cochrane review from 2000(withdrawn due to age) concludes:"…lack of randomised trials means that no conclusions can be drawn on the issue of surgical versus non-surgical treatment of meniscus injuries". This is up to this point no studies that shows a positive benefit from APM compared to other treatment modalities. Those studies that exist beyond this point (Moseley 2003, Herrlin 2007, Kirkley 2008) has not shown APM to be better than other treatments (placebo, physiotherapy, medication or exercise). The patients though in these studies were of older age (mean 52 to 62 years) and had already developed symptomatic knee OA. There is but one study of recent age of non-surgical treatment of meniscus tears on younger patients (n32) which recommends an initial course of non-operative treatment. The investigators wish to examine whether the same conditions which applies to the elder patients with knee OA also apply to the younger patients without knee OA.
A mathematical model has been proposed to identify which patients will receive a benefit or not from the APM procedure because, according to the author, an RCT would be controversial with reluctance and lack of equipoise from both surgeons and patients . Meanwhile several editorials suggest that the use of sham procedures should play a larger role in orthopaedic surgery research , , . Furthermore, a recent study of vertebroplasty showed the need for placebo-controlled surgical trials to avoid widespread adoption of new unnecessary interventions in routine care.
ETHICAL CONSIDERATIONS The first thought that comes to many people when introduced to this protocol is: "Is it ethical to perform placebo-controlled RCTs of surgery? However, the initial precept in medicine is "First, do no harm". For example, one cannot imagine a new pharmaceutical product to be marketed without its being compared with a placebo or at least to a similar drug. The investigators assume this process has been undertaken, in spite of the likely adverse effects from any drug.
An equally valid question is, 'Is it ethical not to perform placebo-controlled RCTs within orthopaedics and instead, potentially perform under-researched operations which may not benefit the patient, or actually, do harm?' As mentioned earlier, a recent study of vertebroplasty has effectively shown how a placebo-controlled surgical trial can evaluate a given procedure that has been adopted widely despite an absence of robust evidence.
There are three reasons to perform another placebo-controlled arthroscopy study apart from Moseley's (2003). First, this study will focus on younger patients, second these patients are yet to develop knee OA but are at risk of doing so, and third, a replication study is required to make Moseley's evidence convincing.
A multistep process has been proposed to ensure that sham-controlled surgical trials are performed in an ethical manner :
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Condition ICMJE||Degenerative Meniscus Tear|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Terminated|
|Completion Date||November 2015|
|Primary Completion Date||November 2015 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages||35 Years to 55 Years (Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Denmark|
|Removed Location Countries|
|NCT Number ICMJE||NCT01264991|
|Other Study ID Numbers ICMJE||SJ-183|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Kristoffer Hare, Slagelse Hospital|
|Study Sponsor ICMJE||Slagelse Hospital|
|Collaborators ICMJE||University of Southern Denmark|
|Information Provided By||Slagelse Hospital|
|Verification Date||November 2016|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP