ncbe: New Topographic Classification of Knee Bone Marrow Lesions

• Sponsor: University of Milan (Other)
• Overall Status: Completed
• CT.gov ID: NCT03976141
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Actual Duration (Months): 11.6
• Patients Per Site Per Month: 43.2

Study Details

Study Description

Brief Summary

the investigator are studying a new topographic classification of bone marrow lesion in the knee and validating it.

Condition or Disease	Intervention/Treatment	Phase
Knee Bone Marrow Lesions	Diagnostic Test: mri

Study Design

• Study Type: Observational
• Actual Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Validation of a New Topographic Classification of Bone Marrow Lesions of the Knee
• Actual Study Start Date: May 14, 2019
• Actual Primary Completion Date: May 30, 2019
• Actual Study Completion Date: Apr 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
a	Diagnostic Test: mri; knee mri

Outcome Measures

Primary Outcome Measures

1. The researchers will calculate the prevalence of BMLs in knee MRI and calculate the intra-observer and inter-observer reliability of the new classification proposed. [The lesions will be evaluated on knee MRI performed in the period between January 2017 to December 2018]

   This study proposes a topographic classification for knee BMLs consisting in 5 different types of lesions. the classification proposed will be validated by 3 independent researchers.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• age over 18 with mri with lesion consent given

Exclusion Criteria:

• under mri previous surgery tumors no consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	2) 1° Clinica Ortopedica, ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO	Milano	Milan	Italy	20122

Sponsors and Collaborators

• University of Milan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pietro Randelli, MD, Professor, University of Milan
• ClinicalTrials.gov Identifier: NCT03976141
• Other Study ID Numbers: ncbe
• First Posted: Jun 5, 2019
• Last Update Posted: Nov 16, 2020
• Last Verified: Nov 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 16, 2020