Early Surgery Versus Conservative Therapy for Meniscal Injuries in Older Patients

Not Applicable

Completed

• Conditions: Meniscal Tear
• Interventions: Procedure: Arthroscopic Partial Meniscectomy; Other: Physical Therapy

• Registration Number: NCT01850719
• Lead Sponsor: Onze Lieve Vrouwe Gasthuis

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2013-05-07
• Study First Submitted QC: 2013-05-07
• Study First Posted: 2013-05-09
• Study Start: 2013-07
• Primary Completion: 2017-09
• Study Completion: 2017-10
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-25
• Last Update Posted: 2021-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 321

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arthroscopic Partial Meniscectomy	Arthroscopic Partial Meniscectomy	-
Physical Therapy	Physical Therapy	-

Primary Outcome Measures

Name	Time	Method
International Knee Documentation Committee 'Subjective Knee Form'	3, 6, 12, 24 and 60 months	Primary outcome will be change in physical function from baseline to 2 years measured by the International Knee Documentation Committee (IKDC) 'Subjective Knee Form', which has been validated for meniscal injuries.; In addition, 1) the investigators will perform an economic analysis alongside the Randomized Controlled Trial (RCT) from a societal perspective and a budget impact analysis from societal, government and insurer perspective.; 2) The primary outcome after 5 years will be investigated

Secondary Outcome Measures

Name	Time	Method
RAND-36 Physical Functional Status Scale	3, 6, 12 and 24 months
EQ-5D-5L Quality of life measure	3, 6, 9, 12, 18, 24 and 60 months
Tegner Activity Scale	3, 6, 12 and 24 months
VAS pain score	3, 6, 12, 24 and 60 months
Health Care Utilization and productivity losses	3, 6, 9, 12, 18 and 24 months
Knee Osteoarthritis Outcome Score-Physical functioning Short from (KOOS-PS)	60 months	for physical functioning
Patient Specific Complaints questionnaire	3, 6 ,12 and 24 months
Physical Examination	3 and 24 months	Performance on meniscus specific physical tests, joint line tenderness and the existence of joint effusion in the knee.

Trial Locations

Locations (10)

Medisch Centrum Alkmaar; 🇳🇱 Alkmaar, Noord Holland, Netherlands

St Lucas Andreas Hospital; 🇳🇱 Amsterdam, Noord Holland, Netherlands

Onze Lieve Vrouwe Gasthuis; 🇳🇱 Amsterdam, Noord Holland, Netherlands

Medisch Centrum Jan van Goyen; 🇳🇱 Amsterdam, Noord Holland, Netherlands

Academic Medical Center University of Amsterdam; 🇳🇱 Amsterdam, Noord Holland, Netherlands

Sint Elisabeth Hospital; 🇳🇱 Tilburg, Netherlands

Diakonessenhuis; 🇳🇱 Utrecht, Netherlands

Medisch Centrum Haaglanden; 🇳🇱 Den Haag, Netherlands

Slotervaart Ziekenhuis; 🇳🇱 Amsterdam, Netherlands

Tergooi Ziekenhuis; 🇳🇱 Hilversum, Netherlands