Knee Bone Marrow Lesions Clinical Trial
— ncbeOfficial title:
Validation of a New Topographic Classification of Bone Marrow Lesions of the Knee
| NCT number | NCT03976141 |
| Other study ID # | ncbe |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 14, 2019 |
| Est. completion date | April 30, 2020 |
| Verified date | November 2020 |
| Source | University of Milan |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
the investigator are studying a new topographic classification of bone marrow lesion in the knee and validating it.
| Status | Completed |
| Enrollment | 500 |
| Est. completion date | April 30, 2020 |
| Est. primary completion date | May 30, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - age over 18 with mri with lesion consent given Exclusion Criteria: - under mri previous surgery tumors no consent |
| Country | Name | City | State |
|---|---|---|---|
| Italy | 2) 1° Clinica Ortopedica, ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO | Milano | Milan |
| Lead Sponsor | Collaborator |
|---|---|
| University of Milan |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 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. | The lesions will be evaluated on knee MRI performed in the period between January 2017 to December 2018 |