Early Surgery Versus Conservative Therapy for Meniscal Injuries in Older Patients (ESCAPE)

Onze Lieve Vrouwe Gasthuis

Status

Completed

Conditions

Meniscal Tear

Treatments

Procedure: Arthroscopic Partial Meniscectomy

Other: Physical Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01850719

NL4418.100.13

Details and patient eligibility

About

The purpose of this study is to determine the effectiveness of both arthroscopic knee surgery and physical therapy in the treatment of non-obstructive meniscal injuries in older patients.

The investigators assume equal improvement of physical function in both groups and reduced costs with conservative treatment.

Full description

Rationale: Arthroscopic Partial Meniscectomy (APM) is the most performed orthopaedic procedure and is current standard treatment for patients with meniscal tears. Since superiority of APM over conservative treatment has not well been described and studies with direct comparison between APM and conservative treatment are sparse, therefore there is risk of large healthcare inefficiency.

Study design: Non-inferiority multicenter randomized controlled trial with an economic evaluation alongside. The study will be conducted by the Orthopaedic Research Consortium Mid-West Netherlands and performed in 6 clinics, including 2 academic medical centers.

402 patients between 45 and 70 years with Magnetic Resonance Imaging (MRI)-confirmed symptomatic, non-obstructive meniscal tears will be included. Patients will be assigned to either APM (n=201) or Physical Therapy (PT; n=201), with optional delayed APM (cross-over) when conservative treatment has failed. Block randomization will be done stratified for age and site. Data will be analysed on both intention to treat and per protocol basis.

Measurement points:

Patients will be asked to complete questionnaires at baseline and 3, 6, 9, 12, 18, 24 and 60 months.
At both 3 and 24 months they will visit the outpatient department for physical examination.
At 24 and 60 months an X-ray will be obtained.

Sample size calculation: 402 patients, based on a power of 90%, an alpha of 0.05, a standard deviation of 20 points and a non-inferiority threshold of 8 points on the IKDC 'Subjective Knee Form'. Loss to follow up and cross-over have been taken into account in this calculation.

Enrollment

321 patients

Sex

All

Ages

45 to 70 years old

Volunteers

No Healthy Volunteers

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:
1. 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;
2. A complete Posterior Cruciate Ligament (PCL) injury;
3. Cartilage change down to bone; grade 4 of the Kellgren Lawrence Grading Scale for Osteoarthritis visualized on X-ray;
4. 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.
Patients unable to speak or read Dutch.