Kosteneffectiviteit van vroege chirurgie versus fysiotherapie met optionele verlate meniscectomie in oudere patienten. Een gerandomiseerde multicenter studie.|
|- candidate number||14538|
|- NTR Number||NTR3908|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-mrt-2013|
|- Secondary IDs||WO11.095 / NL44188.100.13 / NCT01850719; CCMO / clinicaltrials.gov|
|- Public Title||Kosteneffectiviteit van vroege chirurgie versus fysiotherapie met optionele verlate meniscectomie in oudere patienten. Een gerandomiseerde multicenter studie.|
|- Scientific Title||Cost-effectiveness of Early Surgery versus Conservative Treatment with Optional Delayed Meniscectomy in older Patients. A Randomized Controlled Trial.|
|- hypothesis||We assume equal improvement of physical function in both groups and reduced costs with conservative treatment.|
|- Healt Condition(s) or Problem(s) studied||Conservative treatment, Physiotherapy, Arthrosis, Tibial meniscus, Arthroscopic Partial Meniscectomy|
|- Inclusion criteria||1. Patients between 45 and 70 years of age at presentation;|
2. A meniscal tear visualized on MRI. The meniscal tear can either be isolated or combined with a partial asymptomatic anterior cruciate ligament (ACL) injury or a asymptomatic degenerative ACL shown on MRI with no abnormal clinical findings (a negative Lachman test and Pivot Shift);
3. Mental Competence;
4. Willingness to comply with follow-up schedule;
5. Written informed consent.
|- Exclusion criteria||1. Knee locking or trauma leading to acute surgery;|
2. One of the following associated injuries on the index knee:
A. A symptomatic partial ACL rupture or any total ACL rupture determined by clinical examination (positive Lachman test and/or positive Pivot Shift) and shown on MRI;
B. A complete PCL injury;
C. Cartilage change down to bone; grade 4 of the Kellgren Lawrence Grading Scale for Osteoarthritis visualized on X-ray;
D. An injury to the lateral/posterolateral ligament complex with significantly increased laxity.
3. A history of knee surgery other than diagnostic arthroscopy on the index knee;
4. Tumors on MRI suspected for a malignancy;
5. Obese patients with BMI > 35;
6. ASA 4-5 (appendix D) patients which can interfere with revalidation;
7. General disease that effects physical function or systemic medication/abuse of steroids (e.g., rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, gout, pseudogout);
8. Any other medical condition or treatment interfering with the completion or assessment of the trial, e.g. contraindications to MRI or surgery;
9. Drugs or alcohol abuse;
10. Patients unable to speak or read Dutch.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2013|
|- planned closingdate||31-dec-2016|
|- Target number of participants||402|
|- Interventions||Intervention group: |
Arthroscopic partial APM is performed within 4 weeks in day-care. No standard physical therapy is prescribed after surgery, as advised by the Dutch Orthopaedic Association Guidelines.
PT consists of 2 sessions of 30 minutes per week for 8 weeks, with a total of 16 sessions. Patients will also be given a home exercise program. These programs are based on a physical therapy program used by Herrlin et al. and is adjusted for our population by a physical therapist (dr. C. Neeter; member of the research group) who earned his PhD degree in the field of the anterior cruciate ligament and is specialized on the knee.
After completion of the PT-sessions, patients will visit the outpatient department to check for function and persistence of symptoms.
Delayed surgery group:
Based on patients complaints, findings during physical examination and the level of pain, the physician and/or surgeon and patient will decide in agreement that conservative treatment has failed and choose for delayed arthroscopic partial meniscectomy. This can be done no earlier than 3 months after randomization during the entire follow up time of the study.
Prior to the delayed APM patients will be asked to answer an extra questionnaire as endpoint of PT. Patients in this group will be analysed in the PT group according to the Intention-to-treat principle.
|- Primary outcome||Primary outcome will be change in physical function from baseline to 2 years measured by the International Knee Documentation Committee (IKDC) 'Subjective Knee Form', which has been validated for meniscal injuries.|
In addition, we will perform an economic analysis alongside the RCT from a societal perspective and a budget impact analysis from societal, government and insurer perspective.
|- Secondary outcome||1. Change in:|
A. General health, measured by RAND-36;
B. Quality of life, measured by EQ-5D5L;
C. VAS, in rest and stress;
D. Level of activity, measured by Tegner Activity Scale (TAS);
E. Patient specific complaints measured by the PSC (patient specific complaints) Questionnaire;
F. Treatment group; number of patients initially treated conservatively, treated secondarily by APM.
We will use the EQ-5D5L to measure Quality Adjusted Life Years (QALY).
2. Productivity losses, measured by Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P);
3. Relation between a participants expectation of treatment and their satisfaction;
4. Physical Examination (PE), consisting of performance on physical tests (squatting with duckwalk, Thessely test, McMurray), the range of motion, joint line tenderness and the existence of joint effusion in the knee;
5. Adverse events including:
A. Minor: prolonged synovial fluid leakage from arthroscopy portals and bleeding;
B. Moderate: surgical site infection, vascular and neurological damage;
C. Severe: septic arthritis, cardiac events, pulmonary embolism and death. Surgical instrument malfunction will be recorded, as well as reoperations including knee arthroplasties and re-hospitalization.
6. We plan a follow up moment at 60 months to see the progression of osteoarthritis, measured with the Kellgren Lawrence Grading Scale for Osteoarthritis.
|- Timepoints||Patients will visit the outpatient department for physical examination (3 and 24 months) and X-rays (24 months). All measurement outcomes will be obtained at baseline, 3, 6, 12 and 24 months, online or by hardcopy if preferable. At 9 and 18 months patients will fill out a short questionnaire to measure costeffectiveness (TiC-P). Patients will be examined by a well experienced clinician at each site. The anticipated enrolment period will be approximately one year with follow up.|
We also plan to perform another long-term outcome measurement after 5 years.
|- Trial web site||www.kniestudie.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| V.A. Graaf, van de|
|- CONTACT for SCIENTIFIC QUERIES||Dr. R.W. Poolman|
|- Sponsor/Initiator ||Onze Lieve Vrouwe Gasthuis (OLVG)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, Stichting Achmea Gezondheidszorg (SAG)|
|- Brief summary||Rationale: |
Current standard treatment of symptomatic non-obstructive meniscal tears in older patients is surgery. Annual costs are 33 million Euros in this patient group (N=15.000) in the Netherlands. Nevertheless, evidence is lacking that supports its superiority over conservative treatment. When conservative treatment is non-inferior to surgery, this strategy alone could save over 12 million Euros on an annual basis.
We therefore risk large healthcare inefficiency, since these patients are treated surgically. The financial benefits of conservative treatment might even be enhanced by an anticipated decrease in the progression to knee osteoarthritis, since fewer knee arthroplasties would be necessary. This could even further decrease the annual costs spent on knee surgeries.
This multicentre randomized controlled trial is designed to compare surgical to conservative treatment of non-obstructive meniscal injuries in older patients.
We assume equal improvement of physical function in both groups and reduced costs with conservative treatment.
Non-inferiority multicenter randomized controlled trial with an economic evaluation alongside. The study will be conducted by the Orthopaedic Research Consortium Mid-West Netherlands and performed in 6 clinics, including 2 academic medical centers.
We will include 402 patients between 45 and 70 years with MRI-confirmed symptomatic, non-obstructive meniscal tears. Two groups of 201 patients are needed to prove non-inferiority of conservative therapy. Block randomization will be done web-based.
Patients will be asked to complete questionnaires at baseline and 3, 6, 12 and 24 months. At both 3 and 24 months they will visit the outpatient department for physical examination. At 24 months an X-ray will be obtained. We also plan a follow-up at 60 months.
Physical function, measured by International Knee Documentation Committee ‘Subjective Knee Form’.
General health (RAND-36), quality of life (EQ-5D5L), level of activity (Tegner Activity Scale), knee pain (question 10 of IKDC ’Subjective Knee Form), productivity losses (TiC-P), patient specific complaints (PSC), correlation between a patient’s expectation and their satisfaction of treatment, physical examination, progression of osteoarthritis and the occurrence of adverse events.
Cost-effectiveness and Budget Impact Analysis:
We will perform a cost-effectiveness and cost-utility analysis from societal perspective. All relevant costs will be measured, valued and analysed. Cost-effectiveness ratios and planes will be established using bootstrapping techniques (5000 replications).
A Budget Impact Analysis will be performed from societal, government and insurer perspective.
Extent of burden:
In this multicenter randomized controlled trial, the current standard treatment, surgery, will be compared to conservative treatment, consisting of 16 sessions of structured physical therapy. Physical therapy is a safe treatment and is not known with any risks or complications. Since patients from the conservative group will be able to undergo delayed surgery when conservative treatment has failed, we are convinced this study is safe and without any additional risks.
|- Main changes (audit trail)|
|- RECORD||18-mrt-2013 - 9-jul-2013|
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar email@example.com