Early Surgery Versus Conservative Therapy for Meniscal Injuries in Older Patients

Meniscal Tear Clinical Trial

— ESCAPE  

Official title:

Cost-effectiveness of Early Surgery Versus Conservative Treatment With Optional Delayed Meniscectomy in Older Patients. A Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01850719
• Other study ID #: NL4418.100.13
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: October 2017

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 321
• Est. completion date: October 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Meniscal Tear

Intervention

Procedure:
• Arthroscopic Partial Meniscectomy
Arthroscopic partial APM is performed within 4 weeks in day-care. No standard physical therapy is prescribed after surgery, as advised by the Dutch Orthopaedic Association Guidelines.

Other:
• Physical Therapy
Conservative treatment consist of 16 sessions PT and a home exercise program. These programs are developed for our population, 45-70 years, with a focus on closed-chain strength exercises and cardiovascular exercises. In case conservative treatment has failed, patients can cross-over and delayed APM is then performed. This can be done, from completion of the PT program, during the entire study.

Locations

Country	Name	City	State
Netherlands	Medisch Centrum Alkmaar	Alkmaar	Noord Holland
Netherlands	Academic Medical Center University of Amsterdam	Amsterdam	Noord Holland
Netherlands	Medisch Centrum Jan van Goyen	Amsterdam	Noord Holland
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam	Noord Holland
Netherlands	Slotervaart Ziekenhuis	Amsterdam
Netherlands	St Lucas Andreas Hospital	Amsterdam	Noord Holland
Netherlands	Medisch Centrum Haaglanden	Den Haag
Netherlands	Tergooi Ziekenhuis	Hilversum
Netherlands	Sint Elisabeth Hospital	Tilburg
Netherlands	Diakonessenhuis	Utrecht

Sponsors (3)

Lead Sponsor	Collaborator
Onze Lieve Vrouwe Gasthuis	Stichting Achmea Gezondheidszor, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

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