Early Surgery Versus Conservative Therapy for Meniscal Injuries in Older Patients (ESCAPE)
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.
Procedure: Arthroscopic Partial Meniscectomy
Other: Physical Therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Cost-effectiveness of Early Surgery Versus Conservative Treatment With Optional Delayed Meniscectomy in Older Patients. A Randomized Controlled Trial.|
- International Knee Documentation Committee 'Subjective Knee Form' [ Time Frame: 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
- EQ-5D-5L Quality of life measure [ Time Frame: 3, 6, 9, 12, 18 and 24 months ] [ Designated as safety issue: No ]
- Tegner Activity Scale [ Time Frame: 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
- Health Care Utilization and productivity losses [ Time Frame: 3, 6, 9, 12, 18 and 24 months ] [ Designated as safety issue: No ]
- Patient Specific Complaints questionnaire [ Time Frame: 3, 6 ,12 and 24 months ] [ Designated as safety issue: No ]
- Physical Examination [ Time Frame: 3 and 24 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
|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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01850719
|Contact: Victor A van de Graaf, MD||0031 0205999111 ext firstname.lastname@example.org|
|Contact: Rudolf W Poolman, MD PhD||0031 0205999111 ext email@example.com|
|Medisch Centrum Alkmaar||Recruiting|
|Alkmaar, Noord Holland, Netherlands|
|Contact: Dirk-Jan Hofstee, MD +31-(0)72 5482500 D.J.Hofstee@mca.nl|
|Principal Investigator: Dirk Jan Hofstee, MD|
|Medisch Centrum Jan van Goyen||Recruiting|
|Amsterdam, Noord Holland, Netherlands, 1075 HN|
|Contact: E LA Mutsaerts, MD PhD 0031 (0)203055817 firstname.lastname@example.org|
|Onze Lieve Vrouwe Gasthuis||Recruiting|
|Amsterdam, Noord Holland, Netherlands, 1090 HM|
|Contact: Victor A van de Graaf 0031 (0)205999111 ext 1067|
|Contact: Rudolf W Poolman 0031 (0)205999111 ext 1065|
|Academic Medical Center University of Amsterdam||Recruiting|
|Amsterdam, Noord Holland, Netherlands, 1100 DD|
|Contact: G MM Kerkhoffs, MD PhD 0031 (0)205669111|
|St Lucas Andreas Hospital||Recruiting|
|Amsterdam, Noord Holland, Netherlands, 1006 AE|
|Contact: J Wolkenfelt, MD 0031 (0)205108911|
|Contact: D Haverkamp, MD PhD|
|Contact: AMJS Vervest, MD PhD email@example.com|
|Spaarne ziekenhuis||Not yet recruiting|
|Contact: PA Nolte, MD PhD firstname.lastname@example.org|
|Sint Elisabeth Hospital||Recruiting|
|Contact: ICJB van den Brand, MD email@example.com|
|Utrecht, Netherlands, 3508 TG|
|Contact: A de Gast, MD PhD 0031 (0)882506912|
|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:||Douwe J Hemrika, 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|