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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Onze Lieve Vrouwe Gasthuis
Sponsor:
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
Zilverenkruis Achmea - Stichting Achmea Gezondheidszorg (SAG)
Information provided by (Responsible Party):
Victor van de Graaf, Onze Lieve Vrouwe Gasthuis
ClinicalTrials.gov Identifier:
NCT01850719
First received: May 7, 2013
Last updated: October 14, 2014
Last verified: October 2014
  Purpose

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 Intervention
Meniscal Tear
Procedure: Arthroscopic Partial Meniscectomy
Other: Physical Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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.

Further study details as provided by Onze Lieve Vrouwe Gasthuis:

Primary Outcome Measures:
  • International Knee Documentation Committee 'Subjective Knee Form' [ Time Frame: 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]

    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:
  • RAND-36 Physical Functional Status Scale [ Time Frame: 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • EQ-5D-5L Quality of life measure [ Time Frame: 3, 6, 9, 12, 18 and 24 months ] [ Designated as safety issue: No ]
  • Tegner Activity Scale [ Time Frame: 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Health Care Utilization and productivity losses [ Time Frame: 3, 6, 9, 12, 18 and 24 months ] [ Designated as safety issue: No ]
  • Patient Specific Complaints questionnaire [ Time Frame: 3, 6 ,12 and 24 months ] [ Designated as safety issue: No ]
  • Physical Examination [ Time Frame: 3 and 24 months ] [ Designated as safety issue: No ]
    Performance on meniscus specific physical tests, joint line tenderness and the existence of joint effusion in the knee.

  • VAS pain score [ Time Frame: 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 402
Study Start Date: July 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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.

  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01850719

Contacts
Contact: Victor A van de Graaf, MD 0031 0205999111 ext 1067 v.a.vandegraaf@olvg.nl
Contact: Rudolf W Poolman, MD PhD 0031 0205999111 ext 1065 r.w.poolman@olvg.nl

Locations
Netherlands
Medisch Centrum Alkmaar Recruiting
Alkmaar, Noord Holland, Netherlands
Contact: Dirk-Jan Hofstee, MD    +31-(0)72 5482500    D.J.Hofstee@mca.nl   
Principal Investigator: Dirk Jan Hofstee, MD         
Medisch Centrum Jan van Goyen Recruiting
Amsterdam, Noord Holland, Netherlands, 1075 HN
Contact: E LA Mutsaerts, MD PhD    0031 (0)203055817    e.l.a.r.mutsaerts@olvg.nl   
Academic Medical Center University of Amsterdam Recruiting
Amsterdam, Noord Holland, Netherlands, 1100 DD
Contact: G MM Kerkhoffs, MD PhD    0031 (0)205669111      
Onze Lieve Vrouwe Gasthuis Recruiting
Amsterdam, Noord Holland, Netherlands, 1090 HM
Contact: Victor A van de Graaf    0031 (0)205999111 ext 1067      
Contact: Rudolf W Poolman    0031 (0)205999111 ext 1065      
St Lucas Andreas Hospital Recruiting
Amsterdam, Noord Holland, Netherlands, 1006 AE
Contact: J Wolkenfelt, MD    0031 (0)205108911      
Slotervaart Ziekenhuis Recruiting
Amsterdam, Netherlands
Contact: D Haverkamp, MD PhD         
Tergooi Ziekenhuis Recruiting
Hilversum, Netherlands
Contact: AMJS Vervest, MD PhD       avervest@tergooi.nl   
Spaarne ziekenhuis Not yet recruiting
Hoofddorp, Netherlands
Contact: PA Nolte, MD PhD       pnolte@spaarneziekenhuis.nl   
Sint Elisabeth Hospital Recruiting
Tilburg, Netherlands
Contact: ICJB van den Brand, MD       i.vd.brand@elisabeth.nl   
Diakonessenhuis Recruiting
Utrecht, Netherlands, 3508 TG
Contact: A de Gast, MD PhD    0031 (0)882506912      
Sponsors and Collaborators
Onze Lieve Vrouwe Gasthuis
ZonMw: The Netherlands Organisation for Health Research and Development
Zilverenkruis Achmea - Stichting Achmea Gezondheidszorg (SAG)
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: Douwe J Hemrika, 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
  More Information

No publications provided

Responsible Party: Victor van de Graaf, MD, Onze Lieve Vrouwe Gasthuis
ClinicalTrials.gov Identifier: NCT01850719     History of Changes
Other Study ID Numbers: NL4418.100.13
Study First Received: May 7, 2013
Last Updated: October 14, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Onze Lieve Vrouwe Gasthuis:
Tibial meniscus
Arthroscopy
Meniscectomy
Conservative treatment
Physical therapy
Osteoarthritis knee joint

ClinicalTrials.gov processed this record on October 23, 2014