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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01850719
Recruitment Status : Completed
First Posted : May 9, 2013
Last Update Posted : September 7, 2018
Sponsor:
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
Stichting Achmea Gezondheidszor
Information provided by (Responsible Party):
Victor van de Graaf, Onze Lieve Vrouwe Gasthuis

Study Description
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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.


Condition or disease Intervention/treatment Phase
Meniscal Tear Procedure: Arthroscopic Partial Meniscectomy Other: Physical Therapy Not Applicable

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 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 321 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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.
Actual Study Start Date : July 2013
Actual Primary Completion Date : September 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. International Knee Documentation Committee 'Subjective Knee Form' [ Time Frame: 3, 6, 12 and 24 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, 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.



Secondary Outcome Measures :
  1. RAND-36 Physical Functional Status Scale [ Time Frame: 3, 6, 12 and 24 months ]
  2. EQ-5D-5L Quality of life measure [ Time Frame: 3, 6, 9, 12, 18 and 24 months ]
  3. Tegner Activity Scale [ Time Frame: 3, 6, 12 and 24 months ]
  4. Health Care Utilization and productivity losses [ Time Frame: 3, 6, 9, 12, 18 and 24 months ]
  5. Patient Specific Complaints questionnaire [ Time Frame: 3, 6 ,12 and 24 months ]
  6. Physical Examination [ Time Frame: 3 and 24 months ]
    Performance on meniscus specific physical tests, joint line tenderness and the existence of joint effusion in the knee.

  7. VAS pain score [ Time Frame: 3, 6, 12 and 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01850719


Locations
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Netherlands
Medisch Centrum Alkmaar
Alkmaar, Noord Holland, Netherlands
St Lucas Andreas Hospital
Amsterdam, Noord Holland, Netherlands, 1006 AE
Medisch Centrum Jan van Goyen
Amsterdam, Noord Holland, Netherlands, 1075 HN
Onze Lieve Vrouwe Gasthuis
Amsterdam, Noord Holland, Netherlands, 1090 HM
Academic Medical Center University of Amsterdam
Amsterdam, Noord Holland, Netherlands, 1100 DD
Slotervaart Ziekenhuis
Amsterdam, Netherlands
Medisch Centrum Haaglanden
Den Haag, Netherlands
Tergooi Ziekenhuis
Hilversum, Netherlands
Sint Elisabeth Hospital
Tilburg, Netherlands
Diakonessenhuis
Utrecht, Netherlands, 3508 TG
Sponsors and Collaborators
Onze Lieve Vrouwe Gasthuis
ZonMw: The Netherlands Organisation for Health Research and Development
Stichting Achmea Gezondheidszor
Investigators
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Victor van de Graaf, MD, Onze Lieve Vrouwe Gasthuis
ClinicalTrials.gov Identifier: NCT01850719    
Other Study ID Numbers: NL4418.100.13
First Posted: May 9, 2013    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Keywords provided by Victor van de Graaf, Onze Lieve Vrouwe Gasthuis:
Tibial meniscus
Arthroscopy
Meniscectomy
 Conservative treatment
Physical therapy
Osteoarthritis knee joint