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Clinical Trials/NCT03462134
NCT03462134
Completed
Not Applicable

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

Onze Lieve Vrouwe Gasthuis1 site in 1 country194 target enrollmentJanuary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Meniscus Lesion
Sponsor
Onze Lieve Vrouwe Gasthuis
Enrollment
194
Locations
1
Primary Endpoint
The ability of orthopaedics surgeons to predict the outcome of treatment
Status
Completed
Last Updated
5 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
January 1, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Onze Lieve Vrouwe Gasthuis
Responsible Party
Principal Investigator
Principal Investigator

Victor van de Graaf

principal investigator

Onze Lieve Vrouwe Gasthuis

Eligibility 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:
  • 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) \>
  • ASA 4-5 patients which can severely interfere with rehabilitation.

Outcomes

Primary Outcomes

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 Outcomes

  • To assess which patient specific factors are found important by orthopaedic surgeons in choosing their treatment of first choice(2 years)

Study Sites (1)

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