Predicting the Outcome After Treatment of Meniscal Tears

February 23, 2021 updated by: Victor van de Graaf, Onze Lieve Vrouwe Gasthuis

Can Orthopaedic Surgeons Predict the Outcome of Treatment in Patients With Meniscal Tears? The Results of an International Survey.

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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

194

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Noord Holland
      • Amsterdam, Noord Holland, Netherlands, 1090 hm
        • Onze Lieve Vrouwe Gasthuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders 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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

March 2, 2018

First Submitted That Met QC Criteria

March 9, 2018

First Posted (Actual)

March 12, 2018

Study Record Updates

Last Update Posted (Actual)

February 24, 2021

Last Update Submitted That Met QC Criteria

February 23, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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