Early Surgery Versus Conservative Therapy for Meniscal Injuries in Older Patients (ESCAPE)

Cost-effectiveness of Early Surgery Versus Conservative Treatment With Optional Delayed Meniscectomy in Older Patients. A Randomized Controlled Trial.

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.

Study Overview

• Status: Completed
• Conditions: Meniscal Tear
• Intervention / Treatment: Procedure: Arthroscopic Partial Meniscectomy; Other: Physical Therapy

Detailed Description

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:

• Patients will be asked to complete questionnaires at baseline and 3, 6, 9, 12, 18, 24 and 60 months.
• At both 3 and 24 months they will visit the outpatient department for physical examination.
• At 24 and 60 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
• Enrollment (Actual): 321
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Slotervaart Ziekenhuis
  • Den Haag, Netherlands
    • Medisch Centrum Haaglanden
  • Hilversum, Netherlands
    • Tergooi Ziekenhuis
  • Tilburg, Netherlands
    • Sint Elisabeth Hospital
  • Utrecht, Netherlands, 3508 TG
    • Diakonessenhuis
  • Noord Holland
    • Alkmaar, Noord Holland, Netherlands
      • Medisch Centrum Alkmaar
    • Amsterdam, Noord Holland, Netherlands, 1090 hm
      • Onze Lieve Vrouwe Gasthuis
    • Amsterdam, Noord Holland, Netherlands, 1006 AE
      • St Lucas Andreas Hospital
    • Amsterdam, Noord Holland, Netherlands, 1075 HN
      • Medisch Centrum Jan van Goyen
    • Amsterdam, Noord Holland, Netherlands, 1100 DD
      • Academic Medical Center University of Amsterdam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients between 45 and 70 years of age at presentation.
• 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 an asymptomatic degenerative ACL shown on MRI with no abnormal clinical findings (a negative Lachman test and Pivot Shift).
• Mental Competence.
• Willingness to comply with follow up schedule.
• Written informed consent.

Exclusion Criteria:

• Knee locking or trauma leading to acute surgery.

• One of the following associated injuries on the index knee:

  1. 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;
  2. A complete Posterior Cruciate Ligament (PCL) injury;
  3. Cartilage change down to bone; grade 4 of the Kellgren Lawrence Grading Scale for Osteoarthritis visualized on X-ray;
  4. An injury to the lateral/posterolateral ligament complex with significantly increased laxity.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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 Names: APM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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		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

Collaborators and Investigators

• Sponsor: Onze Lieve Vrouwe Gasthuis
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development; Stichting Achmea Gezondheidszor
• Investigators: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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. Erratum In: JAMA. 2018 Dec 4;320(21):2272-2273. JAMA. 2020 Mar 10;323(10):1001.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2013
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: May 7, 2013
• First Submitted That Met QC Criteria: May 7, 2013
• First Posted (Estimate): May 9, 2013

Study Record Updates

• Last Update Posted (Actual): June 30, 2021
• Last Update Submitted That Met QC Criteria: June 25, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Physical therapy; Conservative treatment; Arthroscopy; Meniscectomy; Tibial meniscus; Osteoarthritis knee joint
• Other Study ID Numbers: NL4418.100.13