Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT03462134
Eligibility 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.
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
70 Years
Study:
NCT03462134
Study Brief:
Protocol Section:
NCT03462134