NCT03462134

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
194

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 12, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

1.9 years

First QC Date

March 2, 2018

Last Update Submit

February 23, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • The ability of orthopaedics surgeons to predict the outcome of treatment

    In this survey, participants are provided with 20 cases and asked for their treatment of choice (APM or physical therapy). Subsequently, participants are asked for the expected outcome, which is change in knee function on the International Knee Documentation Committee 'Subjective Knee Form' (IKDC). These data are used to assess to what extend orthopaedic surgeons are capable of predicting the outcome of surgical and non-operative treatment of meniscal tears in a random sample of patients from the Escape trial.

    2 years

Secondary Outcomes (1)

  • To assess which patient specific factors are found important by orthopaedic surgeons in choosing their treatment of first choice

    2 years

Study Arms (1)

Survey amongst orthopaedic surgeons

Selected of 20 patients from the Escape trial (NCT01850719)

Other: Survey

Interventions

SurveyOTHER

Survey amongst orthopaedic surgeons

Survey amongst orthopaedic surgeons

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1. Orthopaedic surgeons and residents registered at the Dutch Orthopaedic Associations. 2. A sample of orthopaedic surgeons from Australia

You may not qualify if:

  • 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.
  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Onze Lieve Vrouwe Gasthuis

Amsterdam, North Holland, 1090 HM, Netherlands

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 2, 2018

First Posted

March 12, 2018

Study Start

January 1, 2018

Primary Completion

December 1, 2019

Study Completion

January 1, 2020

Last Updated

February 24, 2021

Record last verified: 2021-02

Locations