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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
| Stichting Achmea Gezondheidszor | OTHER |
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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.
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.
Measurement points:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arthroscopic Partial Meniscectomy | Experimental |
| |
| Physical Therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arthroscopic Partial Meniscectomy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| International Knee Documentation Committee 'Subjective Knee Form' | 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, 1) 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. 2) The primary outcome after 5 years will be investigated | 3, 6, 12, 24 and 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| RAND-36 Physical Functional Status Scale | 3, 6, 12 and 24 months | |
| EQ-5D-5L Quality of life measure | 3, 6, 9, 12, 18, 24 and 60 months | |
| Tegner Activity Scale |
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Inclusion Criteria:
Exclusion Criteria:
Knee locking or trauma leading to acute surgery.
One of the following associated injuries on the index knee:
A history of knee surgery other than diagnostic arthroscopy on the index knee.
Tumors on MRI suspected for a malignancy.
Obese patients with Body Mass Index (BMI) > 35.
ASA 4-5 patients which can severely interfere with rehabilitation.
General disease that effects physical function or systemic medication/abuse of steroids (e.g., rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, gout, pseudogout)
Any other medical condition or treatment interfering with the completion or assessment of the trial, e.g. contraindications to MRI or surgery.
Drugs or alcohol abuse.
Patients unable to speak or read Dutch.
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| Name | Affiliation | Role |
|---|---|---|
| Rudolf W Poolman, MD PhD | Dept. Orthopaedic Surgery Onze Lieve Vrouwe Gasthuis | Principal Investigator |
| Arthur de Gast, MD PhD | Dept. Orthopaedic Surgery Diakonessenhuis, Utrecht | Principal Investigator |
| Thijs ThM van der SChoot, MD PhD | Dean Board of Directors Onze Lieve Vrouwe Gasthuis | Study Chair |
| Eduard LA Mutsaerts, MD PhD | Dept. of Orthopaedic Surgery Onze Lieve Vrouwe Gasthuis | Principal Investigator |
| Victor A van de Graaf, MD | Dept. of Orthopaedic Surgery Onze Lieve Vrouwe Gasthuis | Study Chair |
| 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 | Principal Investigator |
| Maurits W van Tulder, professor | Professor of Health Technology Assessment Dept. Health Sciences VU University Amsterdam | Study Director |
| Vanessa AB Scholtes, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medisch Centrum Alkmaar | Alkmaar | North Holland | Netherlands | |||
| St Lucas Andreas Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35802374 | Derived | Noorduyn JCA, van de Graaf VA, Willigenburg NW, Scholten-Peeters GGM, Kret EJ, van Dijk RA, Buchbinder R, Hawker GA, Coppieters MW, Poolman RW; ESCAPE Research Group. Effect of Physical Therapy vs Arthroscopic Partial Meniscectomy in People With Degenerative Meniscal Tears: Five-Year Follow-up of the ESCAPE Randomized Clinical Trial. JAMA Netw Open. 2022 Jul 1;5(7):e2220394. doi: 10.1001/jamanetworkopen.2022.20394. | |
| 33195707 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | May 15, 2021 | Jun 25, 2021 |
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|
| Physical Therapy | Other | 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. |
|
| 3, 6, 12 and 24 months |
| Health Care Utilization and productivity losses | 3, 6, 9, 12, 18 and 24 months |
| Patient Specific Complaints questionnaire | 3, 6 ,12 and 24 months |
| Physical Examination | Performance on meniscus specific physical tests, joint line tenderness and the existence of joint effusion in the knee. | 3 and 24 months |
| VAS pain score | 3, 6, 12, 24 and 60 months |
| Knee Osteoarthritis Outcome Score-Physical functioning Short from (KOOS-PS) | for physical functioning | 60 months |
| 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 | Study Director |
| Ewoud RA van Arkel, MD PhD | Dept. of Orthopaedic Surgery MC Haaglanden | Principal Investigator |
| Amsterdam |
| North Holland |
| 1006 AE |
| Netherlands |
| Medisch Centrum Jan van Goyen | Amsterdam | North Holland | 1075 HN | Netherlands |
| Onze Lieve Vrouwe Gasthuis | Amsterdam | North Holland | 1090 HM | Netherlands |
| Academic Medical Center University of Amsterdam | Amsterdam | North Holland | 1100 DD | Netherlands |
| Slotervaart Ziekenhuis | Amsterdam | Netherlands |
| Tergooi Ziekenhuis | Hilversum | Netherlands |
| Medisch Centrum Haaglanden | The Hague | Netherlands |
| Sint Elisabeth Hospital | Tilburg | Netherlands |
| Diakonessenhuis | Utrecht | 3508 TG | Netherlands |
| Derived |
| Noorduyn JCA, Glastra van Loon T, van de Graaf VA, Willigenburg NW, Butter IK, Scholten-Peeters GGM, Coppieters MW, Poolman RW; ESCAPE Research Group; Scholtes VAB, Mutsaerts ELAR, Krijnen MR, Moojen DJF, van Deurzen DFP, Bloembergen CH, Wolkenfelt J, de Gast A, Snijders T, Saris DBF, Wolterbeek N, Neeter C, Kerkhoffs GMMJ, Peters RW, van den Brand ICJB, de Vos-Jakobs S, Spoor AB, Gosens T, Rezaie W, Hofstee DJ, Burger BJ, Haverkamp D, Vervest AMJS, van Rheenen TA, Wijsbek AE, van Arkel ERA, Thomassen BJW, Sprague S, van Tulder MW, Schavemaker M, van Dijk R, van der Kraan J. Functional Outcomes of Arthroscopic Partial Meniscectomy Versus Physical Therapy for Degenerative Meniscal Tears Using a Patient-Specific Score: A Randomized Controlled Trial. Orthop J Sports Med. 2020 Oct 29;8(10):2325967120954392. doi: 10.1177/2325967120954392. eCollection 2020 Oct. |
| 31227493 | Derived | van de Graaf VA, van Dongen JM, Willigenburg NW, Noorduyn JCA, Butter IK, de Gast A, Saris DBF, van Tulder MW, Poolman RW; ESCAPE Research Group. How do the costs of physical therapy and arthroscopic partial meniscectomy compare? A trial-based economic evaluation of two treatments in patients with meniscal tears alongside the ESCAPE study. Br J Sports Med. 2020 May;54(9):538-545. doi: 10.1136/bjsports-2018-100065. Epub 2019 Jun 21. |
| 30285177 | Derived | van de Graaf VA, Noorduyn JCA, Willigenburg NW, Butter IK, de Gast A, Mol BW, Saris DBF, Twisk JWR, Poolman RW; ESCAPE Research Group. Effect of Early Surgery vs Physical Therapy on Knee Function Among Patients With Nonobstructive Meniscal Tears: The ESCAPE Randomized Clinical Trial. JAMA. 2018 Oct 2;320(13):1328-1337. doi: 10.1001/jama.2018.13308. |
| 28003302 | Derived | van de Graaf VA, Scholtes VA, Wolterbeek N, Noorduyn JC, Neeter C, van Tulder MW, Saris DB, de Gast A, Poolman RW; Escape Research Group. Cost-effectiveness of Early Surgery versus Conservative Treatment with Optional Delayed Meniscectomy for Patients over 45 years with non-obstructive meniscal tears (ESCAPE study): protocol of a randomised controlled trial. BMJ Open. 2016 Dec 21;6(12):e014381. doi: 10.1136/bmjopen-2016-014381. |
| SAP_000.pdf |
| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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