Meniscal TearESCAPENCT01850719

Early Surgery Versus Conservative Therapy for Meniscal Injuries in Older Patients

A study testing Arthroscopic Partial Meniscectomy and Physical Therapy in people with Meniscal Tear, run by Onze Lieve Vrouwe Gasthuis at 10 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 45 to 70 years
Conditions the study is for: Meniscal Tear
What is being tested?: Arthroscopic Partial Meniscectomy and Physical Therapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 321 participants
Where: 10 sitesNetherlands
Study dates: Jul 2013to Oct 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

Knee locking or trauma leading to acute surgery.
One of the following associated injuries on the index knee:
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;
A complete Posterior Cruciate Ligament (PCL) injury;
Cartilage change down to bone; grade 4 of the Kellgren Lawrence Grading Scale for Osteoarthritis visualized on X-ray;
An injury to the lateral/posterolateral ligament complex with significantly increased laxity.

Show all 14Show fewer

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.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

Netherlands10 sites

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

Other trials in Netherlands

About this study

Official title: 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.

Read the 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.

Conditions: Meniscal Tear
Being tested: Arthroscopic Partial Meniscectomy, Physical Therapy
Keywords: Tibial meniscus, Arthroscopy, Meniscectomy, Conservative treatment, Physical therapy, Osteoarthritis knee joint

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Arthroscopic Partial MeniscectomyProcedure or surgery
Also called APM
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.
Physical TherapyOther
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.

Study groups in NCT01850719
Study group	Role	What they receive
Arthroscopic Partial Meniscectomy	Experimental	Not described Receives: Procedure: Arthroscopic Partial Meniscectomy
Physical Therapy	Active comparator	Not described Receives: Other: Physical Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
1. The primary outcome after 5 years will be investigated
Measured: 3, 6, 12, 24 and 60 months

Secondary outcomes (8)

RAND-36 Physical Functional Status Scale
Measured: 3, 6, 12 and 24 months
EQ-5D-5L Quality of life measure
Measured: 3, 6, 9, 12, 18, 24 and 60 months
Tegner Activity Scale
Measured: 3, 6, 12 and 24 months
Health Care Utilization and productivity losses
Measured: 3, 6, 9, 12, 18 and 24 months
Patient Specific Complaints questionnaire
Measured: 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.
Measured: 3 and 24 months
VAS pain score
Measured: 3, 6, 12, 24 and 60 months
Knee Osteoarthritis Outcome Score-Physical functioning Short from (KOOS-PS)
for physical functioning
Measured: 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2013Oct 2017

First posted9 May 2013 (estimated)
Study startJul 2013
Primary completionSep 2017
Study completionOct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Meniscal TearStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 321 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01850719
Sponsor's protocol ID: NL4418.100.13
Acronym: ESCAPE
Status last verified: Jun 2021
First submitted: 7 May 2013
Last updated: 30 Jun 2021
Results posted: No
Data monitoring committee: No

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.
PubMed 35802374
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.
PubMed 33195707
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.
PubMed 31227493
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.
PubMed 30285177
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.
PubMed 28003302

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Meniscal Tear trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cost-effectiveness of Early Surgery Versus Conservative Treatment With Optional Delayed Meniscectomy in Older Patients. A Randomized Controlled Trial.
ClinicalTrials.gov ID: NCT01850719
Acronym / sponsor ID: ESCAPE / NL4418.100.13
Conditions: Meniscal Tear
Keywords: Tibial meniscus, Arthroscopy, Meniscectomy, Conservative treatment, Physical therapy, Osteoarthritis knee joint
Study type: Interventional
Recruitment status: Completed
Enrolment: 321 participants (actual)
Lead sponsor: Onze Lieve Vrouwe GasthuisUniversity, hospital or other
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development, Stichting Achmea Gezondheidszor
Study start: Jul 2013 (actual)
Primary completion: Sep 2017 (actual)
Study completion: Oct 2017 (actual)
First posted: 9 May 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arthroscopic Partial Meniscectomy	Experimental	Procedure: Arthroscopic Partial Meniscectomy
Physical Therapy	Active comparator	Other: Physical Therapy

Who may qualify

Ages: 45 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (14 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Arthroscopic Partial MeniscectomyAlso: APMArthroscopic 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.	Procedure or surgery	Arthroscopic Partial Meniscectomy
Physical TherapyConservative 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.	Other	Physical Therapy

Primary outcome

International Knee Documentation Committee 'Subjective Knee Form'
Time frame: 3, 6, 12, 24 and 60 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, 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

8 secondary outcomes

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, 24 and 60 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
VAS pain score
Time frame: 3, 6, 12, 24 and 60 months
Knee Osteoarthritis Outcome Score-Physical functioning Short from (KOOS-PS)
Time frame: 60 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
Derived from this study: PubMed 35802374Noorduyn 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.
Derived from this study: PubMed 33195707Noorduyn 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.
Derived from this study: PubMed 31227493van 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.
Derived from this study: PubMed 30285177van 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.
Derived from this study: PubMed 28003302van 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rudolf W Poolman, MD PhD principal investigator

Dept. Orthopaedic Surgery Onze Lieve Vrouwe Gasthuis

Arthur de Gast, MD PhD principal investigator

Dept. Orthopaedic Surgery Diakonessenhuis, Utrecht

Thijs ThM van der SChoot, MD PhD study chair

Dean Board of Directors Onze Lieve Vrouwe Gasthuis

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Arthroscopic Partial Meniscectomy and Physical Therapy in people with Meniscal Tear, run by Onze Lieve Vrouwe Gasthuis at 10 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

International Knee Documentation Committee 'Subjective Knee Form' (time frame: 3, 6, 12, 24 and 60 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01850719, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2021; AzTrials last refreshed its copy on 7 Nov 2026.