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Predicting the Outcome After Treatment of Meniscal Tears

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: NCT03462134
Recruitment Status : Completed
First Posted : March 12, 2018
Last Update Posted : February 24, 2021
Sponsor:
Collaborators:
University of New South Wales
Mayo Clinic
Information provided by (Responsible Party):
Victor van de Graaf, Onze Lieve Vrouwe Gasthuis

Brief Summary:
In this study the investigators examined the ability of orthopaedic surgeons to predict the outcome of surgery and non-operative treatment in patients (age 45 to 70) with a non-obstructive meniscal tear.

Condition or disease Intervention/treatment
Meniscus Lesion Surveys and Questionnaires Other: Survey

Detailed Description:

The additional benefits of Arthroscopic Partial Meniscectomy (APM) in middle aged patients with a non-obstructive meniscal tear are under scrutiny for years. Despite the most recent publications recommending to apply non-operative treatment (exercise therapy, injections, drugs) instead of APM in this patient group, the expected decrease in number of operations is slower then expected. Orthopaedic surgeons therefore seem unconvinced by the evidence to change practice.

For this reason the investigators conducted an international survey amongst orthopaedic surgeons in which the investigators aimed to (1) determine the ability of orthopaedic surgeons to predict the outcomes of APM and physical therapy (PT) in middle aged patients with a non-obstructive meniscal tear, and (2) to determine which patient factors direct surgeons towards APM and towards PT.

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Study Type : Observational
Actual Enrollment : 194 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Can Orthopaedic Surgeons Predict the Outcome of Treatment in Patients With Meniscal Tears? The Results of an International Survey.
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Group/Cohort Intervention/treatment
Survey amongst orthopaedic surgeons
Selected of 20 patients from the Escape trial (NCT01850719)
Other: Survey
Survey amongst orthopaedic surgeons




Primary Outcome Measures :
  1. The ability of orthopaedics surgeons to predict the outcome of treatment [ Time Frame: 2 years ]

    In this survey, participants are provided with 20 cases and asked for their treatment of choice (APM or physical therapy). Subsequently, participants are asked for the expected outcome, which is change in knee function on the International Knee Documentation Committee 'Subjective Knee Form' (IKDC).

    These data are used to assess to what extend orthopaedic surgeons are capable of predicting the outcome of surgical and non-operative treatment of meniscal tears in a random sample of patients from the Escape trial.



Secondary Outcome Measures :
  1. To assess which patient specific factors are found important by orthopaedic surgeons in choosing their treatment of first choice [ Time Frame: 2 years ]

    In this survey, participants are asked to choose from a list of patient specific factors, which of these direct their treatment choice toward APM, and which towards non-operative treatment.

    These data are used to examine which patient specific factors are directing orthopaedic surgeons towards APM and towards PT. These factors will help future research focusing in creating patient specific profiles.




Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
  1. Orthopaedic surgeons and residents registered at the Dutch Orthopaedic Associations.
  2. A sample of orthopaedic surgeons from Australia
Criteria

In this survey the investigators invited orthopaedic surgeons and residents from both the Netherlands and Australia to complete a meniscus survey, including a random sample of patients from the Escape trial. The in-/exclusion criteria are listed below.

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:
  • 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.
  • 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.

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): NCT03462134


Locations
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Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, Noord Holland, Netherlands, 1090 HM
Sponsors and Collaborators
Onze Lieve Vrouwe Gasthuis
University of New South Wales
Mayo Clinic
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Victor van de Graaf, principal investigator, Onze Lieve Vrouwe Gasthuis
ClinicalTrials.gov Identifier: NCT03462134    
Other Study ID Numbers: 1
First Posted: March 12, 2018    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No