Subchondroplasty Procedure in Patients With Bone Marrow Lesions
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Bone Marrow Edema
- Bone Marrow Lesions
- Type
- Observational
- Design
- Observational Model: Case-OnlyTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Patients with symptomatic BML(s) of the knee(s) who qualify for a SCP Procedure will be invited to participate. This study will enroll up to 250 patients across 10 investigative centers in Europe over a period of 12 months. The maximum study duration is expected to be 6 years. Follow-up assessments ...
Patients with symptomatic BML(s) of the knee(s) who qualify for a SCP Procedure will be invited to participate. This study will enroll up to 250 patients across 10 investigative centers in Europe over a period of 12 months. The maximum study duration is expected to be 6 years. Follow-up assessments will be conducted at 1 month, 3, 6, 12-months and annually up to 5 years post injection; and subjects will be asked questions regarding their pain and functioning to further understand long-term outcomes. For a subset of approximately 100 consecutive subjects at selected centers, a long standing X-ray and MRI at screening and 12 months will be obtained.
Tracking Information
- NCT #
- NCT03430219
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Peter Angele, Prof.Dr.med University of Regensburg
Get Well Soon