Årsrapport 2011 - Region Sjælland

The SLAMSHAM study
A Randomized Placebo Controlled Study of Arthroscopic Partial Meniscectomy
Kristoffer B Hare, L Stefan Lohmander, Ewa M Roos
PURPOSE
The overall purpose of this study is to test whether the benefit from
arthroscopic partial meniscectomy in patients aged 35-55 with knee
pain and a degenerative meniscus lesion, is due to surgery or the
placebo effect. Demonstration of no additional benefit from this
surgery may reduce the development of surgically-related
osteoarthritis in middle-aged patients.
BACKGROUND
Osteoarthritis (OA) is the most common form of arthritis and the
knee is one of the most affected joints. Meniscus lesions are
associated with knee OA, but it is unclear whether as a risk factor or a
sign of the disease. The current treatment for a degenerative
meniscus tear is arthroscopic partial meniscectomy (APM) with 1
million procedure being performed per year in the US. There is strong
evidence that APM puts the knee at high risk of later OA. Earlier
studies have shown a placebo effect from surgery in subjects with
established OA. The effect of APM in younger subjects with no or
mild OA is unknown.
kbhr@regionsjaelland.dk
DESIGN
The study is a double-blind randomized placebo-controlled multicentre
trial. Patients referred from general practitioners will be
screened. If eligible, oral and written information about the study
including a 10 minute video will be given to the patients. If MRI
confirms medial meniscus lesion the patient will be included in the
study and randomized to meniscectomy or sham procedure. All
patients will be seen at a 3 month, and 2 and 5 year follow-up
(Flowchart).
Referred from general practitioner
Patients who meet the criteria of age are selected for further screening
First Visit - Screened for eligibility
Screening includes x-ray and clinical examination. All patients are given the KOOS score to fill out at home.
Eligible patients are referred to an MRI and given written material and a information video about the study
to view at home.
Second visit
MRI scan and functionality test
Eligible
Patients are informed by telephone of MRI findings
and asked if they wish to participate in the study.
Enrolled
Enrolled patients are put through a functionality test immediately after enrolment
and signed up for surgery
Baseline
At now all patients should have established a baseline including, a clinical
examination, x-rays, MRI, functionality test and a KOOS score
Arthroscopic Partial
Meniscectomy
3 month follow-up
Clinical examination, functionality test
and KOOS score (filled out at home)
2 year follow-up
Clinical examination, functionality test
and KOOS score (filled out at home)
5 year follow-up
Fixed-flexion radiography
Randomization
Will take place at the time of surgery
Placebo procedure
3 month follow-up
Clinical examination, functionality test
and KOOS score (filled out at home)
2 year follow-up
Clinical examination, functionality test
and KOOS score (filled out at home)
5 year follow-up
Fixed-flexion radiography
Ineligible
Informed of MRI findings by telephone.
Refused to participate
Enrolled in an observational cohort
Observational Cohort
No intervention
3 month follow-up
Clinical examination, functionality test
and KOOS score (filled out at home)
2 year follow-up
Clinical examination, functionality test
and KOOS score (filled out at home)
5 year follow-up
Fixed-flexion radiography
The study is approved by the The Regional Committee on Biomedical Research Ethics and
consistent with the declaration of Helsinki.
METHODS
Participants
Patients 35 -55 years of age with knee pain for more than 2 months without significant trauma and an MRI confirmed medial meniscus lesion.
Patients must be eligible for outpatient surgery and will be excluded if they are in need of acute surgery e.g. locked knee or high-energy trauma.
Patients with Kellgren-Lawrence grade 3 or 4 knee OA, or knee surgery within the last 2 years will also be excluded.
Primary outcome
The primary outcome at 2 years follow-up is KOOS 5, derived from a self-reported questionnaire, the Knee injury and Osteoarthritis Outcome
Score (KOOS), comprising five different subscales; a) pain, b) other symptoms, c) activities in daily living, d) function in sport and recreation, e)
knee-related quality of life (www.koos.nu).
Secondary outcomes
All five KOOS subscales are used as secondary outcomes. A physical function test will be performed after 3 and 24 months including a one-leg
jump test, maximal number of knee bends in 30 seconds and isometric strength knee extension strength.
Development of knee OA
Fixed-flexion radiography, with use of SynaFlex®, will asses the long-term development of OA.
ÅRSRAPPORT 2011 91