Early Surgery Versus Conservative Therapy for Meniscal Injuries in Older Patients (ESCAPE)
|ClinicalTrials.gov Identifier: NCT01850719|
Recruitment Status : Active, not recruiting
First Posted : May 9, 2013
Last Update Posted : December 26, 2017
The purpose of this study is to determine the effectiveness of both arthroscopic knee surgery and physical therapy in the treatment of non-obstructive meniscal injuries in older patients.
The investigators assume equal improvement of physical function in both groups and reduced costs with conservative treatment.
|Condition or disease||Intervention/treatment|
|Meniscal Tear||Procedure: Arthroscopic Partial Meniscectomy Other: Physical Therapy|
Rationale: Arthroscopic Partial Meniscectomy (APM) is the most performed orthopaedic procedure and is current standard treatment for patients with meniscal tears. Since superiority of APM over conservative treatment has not well been described and studies with direct comparison between APM and conservative treatment are sparse, therefore there is risk of large healthcare inefficiency.
Study design: 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.
402 patients between 45 and 70 years with Magnetic Resonance Imaging (MRI)-confirmed symptomatic, non-obstructive meniscal tears will be included. Patients will be assigned to either APM (n=201) or Physical Therapy (PT; n=201), with optional delayed APM (cross-over) when conservative treatment has failed. Block randomization will be done stratified for age and site. Data will be analysed on both intention to treat and per protocol basis.
- Patients will be asked to complete questionnaires at baseline and 3, 6, 9, 12, 18 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.
Sample size calculation: 402 patients, based on a power of 90%, an alpha of 0.05, a standard deviation of 20 points and a non-inferiority threshold of 8 points on the IKDC 'Subjective Knee Form'. Loss to follow up and cross-over have been taken into account in this calculation.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||321 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cost-effectiveness of Early Surgery Versus Conservative Treatment With Optional Delayed Meniscectomy in Older Patients. A Randomized Controlled Trial.|
|Actual Study Start Date :||July 2013|
|Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||July 2018|
|Experimental: Arthroscopic Partial Meniscectomy||
Procedure: Arthroscopic Partial Meniscectomy
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.
Other Name: APM
|Active Comparator: Physical Therapy||
Other: Physical Therapy
Conservative treatment consist of 16 sessions PT and a home exercise program. These programs are developed for our population, 45-70 years, with a focus on closed-chain strength exercises and cardiovascular exercises.
In case conservative treatment has failed, patients can cross-over and delayed APM is then performed. This can be done, from completion of the PT program, during the entire study.
- International Knee Documentation Committee 'Subjective Knee Form' [ Time Frame: 3, 6, 12 and 24 months ]
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, the investigators will perform an economic analysis alongside the Randomized Controlled Trial (RCT) from a societal perspective and a budget impact analysis from societal, government and insurer perspective.
- RAND-36 Physical Functional Status Scale [ Time Frame: 3, 6, 12 and 24 months ]
- EQ-5D-5L Quality of life measure [ Time Frame: 3, 6, 9, 12, 18 and 24 months ]
- Tegner Activity Scale [ Time Frame: 3, 6, 12 and 24 months ]
- Health Care Utilization and productivity losses [ Time Frame: 3, 6, 9, 12, 18 and 24 months ]
- Patient Specific Complaints questionnaire [ Time Frame: 3, 6 ,12 and 24 months ]
- Physical Examination [ Time Frame: 3 and 24 months ]Performance on meniscus specific physical tests, joint line tenderness and the existence of joint effusion in the knee.
- VAS pain score [ Time Frame: 3, 6, 12 and 24 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01850719
|Medisch Centrum Alkmaar|
|Alkmaar, Noord Holland, Netherlands|
|St Lucas Andreas Hospital|
|Amsterdam, Noord Holland, Netherlands, 1006 AE|
|Medisch Centrum Jan van Goyen|
|Amsterdam, Noord Holland, Netherlands, 1075 HN|
|Onze Lieve Vrouwe Gasthuis|
|Amsterdam, Noord Holland, Netherlands, 1090 HM|
|Academic Medical Center University of Amsterdam|
|Amsterdam, Noord Holland, Netherlands, 1100 DD|
|Medisch Centrum Haaglanden|
|Den Haag, Netherlands|
|Sint Elisabeth Hospital|
|Utrecht, Netherlands, 3508 TG|
|Principal Investigator:||Rudolf W Poolman, MD PhD||Dept. Orthopaedic Surgery Onze Lieve Vrouwe Gasthuis|
|Principal Investigator:||Arthur de Gast, MD PhD||Dept. Orthopaedic Surgery Diakonessenhuis, Utrecht|
|Study Chair:||Thijs ThM van der SChoot, MD PhD||Dean Board of Directors Onze Lieve Vrouwe Gasthuis|
|Principal Investigator:||Eduard LA Mutsaerts, MD PhD||Dept. of Orthopaedic Surgery Onze Lieve Vrouwe Gasthuis|
|Study Chair:||Victor A van de Graaf, MD||Dept. of Orthopaedic Surgery Onze Lieve Vrouwe Gasthuis|
|Principal Investigator:||Gino MM Kerkhoffs, MD PhD||Dept. of Orthopaedic Surgery Academic Medical Center University of Amsterdam|
|Principal Investigator:||Julius Wolkenfelt, MD||Dept. of Orthopaedic Surgery St. Lucas Andreas Hospital|
|Study Director:||Maurits W van Tulder, professor||Professor of Health Technology Assessment Dept. Health Sciences VU University Amsterdam|
|Study Director:||Vanessa AB Scholtes, PhD||Research coordinator Dept. of Orthopaedic Surgery Onze Lieve Vrouwe Gasthuis|
|Study Director:||Nienke Wolterbeek, PhD||Research coordinator Dept. of Orthopaedic Surgery St. Antonius Hospital|
|Study Director:||Camille Neeter, PhD||Neeter Physiotherapy Amsterdam|
|Principal Investigator:||Ewoud RA van Arkel, MD PhD||Dept. of Orthopaedic Surgery MC Haaglanden|