Status:
COMPLETED
Early Surgery Versus Conservative Therapy for Meniscal Injuries in Older Patients
Lead Sponsor:
Onze Lieve Vrouwe Gasthuis
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Stichting Achmea Gezondheidszor
Conditions:
Meniscal Tear
Eligibility:
All Genders
45-70 years
Phase:
NA
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 investi...
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 conserv...
Eligibility Criteria
Inclusion
- 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
- 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.
- Patients unable to speak or read Dutch.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2017
Estimated Enrollment :
321 Patients enrolled
Trial Details
Trial ID
NCT01850719
Start Date
July 1 2013
End Date
October 1 2017
Last Update
June 30 2021
Active Locations (10)
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1
Medisch Centrum Alkmaar
Alkmaar, North Holland, Netherlands
2
St Lucas Andreas Hospital
Amsterdam, North Holland, Netherlands, 1006 AE
3
Medisch Centrum Jan van Goyen
Amsterdam, North Holland, Netherlands, 1075 HN
4
Onze Lieve Vrouwe Gasthuis
Amsterdam, North Holland, Netherlands, 1090 HM