Predicting the Outcome After Treatment of Meniscal Tears

Meniscus Lesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03462134
• Other study ID #: 1
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: January 1, 2020

Study information

• Verified date: February 2021
• Source: Onze Lieve Vrouwe Gasthuis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: January 1, 2020
• Est. primary completion date: December 1, 2019
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Meniscus Lesion
• Surveys and Questionnaires

Intervention

Other:
• Survey
Survey amongst orthopaedic surgeons

Locations

Country	Name	City	State
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam	Noord Holland

Sponsors (3)

Lead Sponsor	Collaborator
Onze Lieve Vrouwe Gasthuis	Mayo Clinic, University of New South Wales

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The ability of orthopaedics surgeons to predict the outcome of treatment	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	To assess which patient specific factors are found important by orthopaedic surgeons in choosing their treatment of first choice	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