Clinical trial NCT01850719: Early Surgery Versus Conservative Therapy for Meniscal Injuries in Older Patients
Official title: Cost-effectiveness of Early Surgery Versus Conservative Treatment With Optional Delayed Meniscectomy in Older Patients. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meniscal Tear
Keywords: Tibial meniscus
Arthroscopy
Meniscectomy
Conservative treatment
Physical therapy
Osteoarthritis knee joint
Lead sponsor: Onze Lieve Vrouwe Gasthuis
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Stichting Achmea Gezondheidszor
First posted: 2013-05-09
Enrollment: 321
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: International Knee Documentation Committee 'Subjective Knee Form'
timeFrame: 3, 6, 12, 24 and 60 months
Secondary outcomes:
measure: RAND-36 Physical Functional Status Scale
timeFrame: 3, 6, 12 and 24 months
measure: EQ-5D-5L Quality of life measure
timeFrame: 3, 6, 9, 12, 18, 24 and 60 months
measure: Tegner Activity Scale
timeFrame: 3, 6, 12 and 24 months
measure: Health Care Utilization and productivity losses
timeFrame: 3, 6, 9, 12, 18 and 24 months
measure: Patient Specific Complaints questionnaire
timeFrame: 3, 6 ,12 and 24 months
measure: Physical Examination
timeFrame: 3 and 24 months
measure: VAS pain score
timeFrame: 3, 6, 12, 24 and 60 months
measure: Knee Osteoarthritis Outcome Score-Physical functioning Short from (KOOS-PS)
timeFrame: 60 months
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: Medisch Centrum Alkmaar
state: Noord Holland
city: Amsterdam
country: Netherlands
facility: St Lucas Andreas Hospital
state: Noord Holland
city: Amsterdam
country: Netherlands
facility: Medisch Centrum Jan van Goyen
state: Noord Holland
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
state: Noord Holland
city: Amsterdam
country: Netherlands
facility: Academic Medical Center University of Amsterdam
state: Noord Holland
city: Amsterdam
country: Netherlands
facility: Slotervaart Ziekenhuis
city: Den Haag
country: Netherlands
facility: Medisch Centrum Haaglanden
city: Hilversum
country: Netherlands
facility: Tergooi Ziekenhuis
city: Tilburg
country: Netherlands
facility: Sint Elisabeth Hospital
city: Utrecht
country: Netherlands
facility: Diakonessenhuis
Study officials:
affiliation: Dept. Orthopaedic Surgery Onze Lieve Vrouwe Gasthuis
name: Rudolf W Poolman, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. Orthopaedic Surgery Diakonessenhuis, Utrecht
name: Arthur de Gast, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dean Board of Directors Onze Lieve Vrouwe Gasthuis
name: Thijs ThM van der SChoot, MD PhD
role: STUDY_CHAIR
affiliation: Dept. of Orthopaedic Surgery Onze Lieve Vrouwe Gasthuis
name: Eduard LA Mutsaerts, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Orthopaedic Surgery Onze Lieve Vrouwe Gasthuis
name: Victor A van de Graaf, MD
role: STUDY_CHAIR
affiliation: Dept. of Orthopaedic Surgery Academic Medical Center University of Amsterdam
name: Gino MM Kerkhoffs, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Orthopaedic Surgery St. Lucas Andreas Hospital
name: Julius Wolkenfelt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Health Technology Assessment Dept. Health Sciences VU University Amsterdam
name: Maurits W van Tulder, professor
role: STUDY_DIRECTOR
affiliation: Research coordinator Dept. of Orthopaedic Surgery Onze Lieve Vrouwe Gasthuis
name: Vanessa AB Scholtes, PhD
role: STUDY_DIRECTOR
affiliation: Research coordinator Dept. of Orthopaedic Surgery St. Antonius Hospital
name: Nienke Wolterbeek, PhD
role: STUDY_DIRECTOR
affiliation: Neeter Physiotherapy Amsterdam
name: Camille Neeter, PhD
role: STUDY_DIRECTOR
affiliation: Dept. of Orthopaedic Surgery MC Haaglanden
name: Ewoud RA van Arkel, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.