The Benefit of Arthroscopic Partial Meniscectomy in Middle-Aged Patients (SLAMSHAM)
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|ClinicalTrials.gov Identifier: NCT01264991|
Recruitment Status : Terminated (Recruitment stalled. Study terminated before inclusion of sufficient number of participants included)
First Posted : December 22, 2010
Last Update Posted : October 24, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Degenerative Meniscus Tear||Procedure: Arthroscopic partial meniscectomy Procedure: Sham procedure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Benefit of Arthroscopic Partial Meniscectomy in Middle-Aged Patients - A Double-Blinded Randomized Placebo (Sham) Controlled Multi-Centre Trial|
|Actual Study Start Date :||February 21, 2011|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
|Experimental: APM group||
Procedure: Arthroscopic partial meniscectomy
The arthroscopic partial meniscectomy will be performed on an outpatient basis by experienced surgeons at a level of at least attending physicians or at the last year of residency. All arthroscopies will be performed in general anaesthesia combined with local anaesthesia. After general anaesthesia is induced, the knee will be examined for stability. Thereafter two standard portals on the lateral and medial side of the ligamentum patella will be created but no outflow cannula inserted. An arthroscope will be used with a pressure-controlled irrigation system. Tourniquet use will be according to surgeon preference. The strategy for the meniscectomy will be to preserve as much tissue as possible. A standard operation protocol will be used to document possible findings in cartilage, ligaments, synovium and the medial and lateral meniscus. Meniscus lesions and type of will be registered and changes in the articular cartilage will be classified according to the ICRS classification
|Placebo Comparator: Sham group||
Procedure: Sham procedure
The placebo procedure will be performed under the same conditions as above. The patient will be fully sedated in general anaesthesia. As above, the stability of the knee will be examined. Local anaesthetic will be applied as above and 2 skin incisions will be made at the same location and the same size as above. Then the knee will be manipulated as if a real arthroscopy were being done, the spillage of water and all the other equipment needed for an arthroscopy will be used and manipulated. No instruments will enter the portals for arthroscopy to avoid the possibility of osteochondral lesions and unwanted interventions by the surgeon.
- 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:
- other symptoms
- activities in daily living (ADL)
- function in sport and recreation
- knee-related quality of life (QOL) A mean of the 5 subscales will be calculated (KOOS5 = [KOOSpain + KOOSsymptoms + KOOSADL + KOOSsport&rec KOOSQOL] / 5. Range 0 to 100, worst to best)
- One-leg jump test [ Time Frame: 2 year follow-up ]Subjects will perform 2 practice trials and then two test trials on each leg. The best of the two test trials will be used. Symmetry indices will be calculated for the one-leg hop test as (injured side/uninjured side) x 100
- Knee-bending test [ Time Frame: 2 year follow-up ]A maximum number of knee-bends performed in 30 seconds as a test for physical function. This test has been used on similar patient groups in other studies and has been found to be a reliable test
- Knee extension strength [ Time Frame: 2 year follow-up ]A handheld dynamometer (Powertrack Commander) will be used to evaluate the quadriceps muscle performance by measuring the knee-extension strength. Isometric muscle testing is commonly used in the literature and the reliability for the isometric muscle tests with a hand held dynamometer have previously been reported to be satisfactory.
- EQ-5D [ Time Frame: 2 year follow-up ]The EQ-5D health score will be evaluated at baseline and at 3 and 24 months as a generic measure of health for clinical and economic appraisal. EQ-5D consists of two pages - the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, severe problems.
- SF-36 [ Time Frame: 2 year follow-up ]The SF-36 Health Survey - Acute (1 week re-call) will be used as a generic measure of patient health status and in differentiating the health benefits produced by the different treatments. This will also be evaluated at baseline and at 3 and 24 months. The SF-36 Is compromised of an 8-scale profile of functional health and well-being scores comparing the relative burden of diseases.
- Development of knee osteoarthritis [ Time Frame: 5 year follow-up ]A fixed-flexion radiography procedure, with use of SynaFlex, will be implemented to investigate the development of OA on a long-term basis . Incident marginal tibiofemoral osteophyte will be the outcome at a 5-year follow-up
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01264991
|Næstved, Region Zealand, Denmark, 4800|
|Slagelse, Region Zealand, Denmark, 4200|
|Study Chair:||Ewa Roos, Professor||Research Unit of Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense|
|Principal Investigator:||Kristoffer B Hare, MD||Dept. of Orthopadeics, Slagelse Hospital, Region Zealand|