Predicting the Outcome After Treatment of Meniscal Tears

NCT ID: NCT03462134

Last Updated: 2021-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

194 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-01-01

Brief Summary

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In this study the investigators examined the ability of orthopaedic surgeons to predict the outcome of surgery and non-operative treatment in patients (age 45 to 70) with a non-obstructive meniscal tear.

Detailed Description

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The additional benefits of Arthroscopic Partial Meniscectomy (APM) in middle aged patients with a non-obstructive meniscal tear are under scrutiny for years. Despite the most recent publications recommending to apply non-operative treatment (exercise therapy, injections, drugs) instead of APM in this patient group, the expected decrease in number of operations is slower then expected. Orthopaedic surgeons therefore seem unconvinced by the evidence to change practice.

For this reason the investigators conducted an international survey amongst orthopaedic surgeons in which the investigators aimed to (1) determine the ability of orthopaedic surgeons to predict the outcomes of APM and physical therapy (PT) in middle aged patients with a non-obstructive meniscal tear, and (2) to determine which patient factors direct surgeons towards APM and towards PT.

Conditions

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Meniscus Lesion Surveys and Questionnaires

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Survey amongst orthopaedic surgeons

Selected of 20 patients from the Escape trial (NCT01850719)

Survey

Intervention Type OTHER

Survey amongst orthopaedic surgeons

Interventions

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Survey

Survey amongst orthopaedic surgeons

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of New South Wales

UNKNOWN

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role collaborator

Onze Lieve Vrouwe Gasthuis

OTHER

Sponsor Role lead

Responsible Party

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Victor van de Graaf

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Onze Lieve Vrouwe Gasthuis

Amsterdam, North Holland, Netherlands

Site Status

Countries

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Netherlands

References

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van de Graaf VA, Bloembergen CH MD, Willigenburg NW PhD, Noorduyn JCA MSc, Saris DB, Harris IA, Poolman RW; ESCAPE Research Group. Can even experienced orthopaedic surgeons predict who will benefit from surgery when patients present with degenerative meniscal tears? A survey of 194 orthopaedic surgeons who made 3880 predictions. Br J Sports Med. 2020 Mar;54(6):354-359. doi: 10.1136/bjsports-2019-100567. Epub 2019 Aug 1.

Reference Type DERIVED
PMID: 31371339 (View on PubMed)

Other Identifiers

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1

Identifier Type: -

Identifier Source: org_study_id

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