Ignite Creation Date:
2024-07-17 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06477315
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-21
Brief Title:
Mid- and Long-term Evaluation of the Results of Patients Undergoing Spinal Cord Stimulation With Microfractures BST CarGel in the Treatment of Patellofemoral Chondral Lesions of the Knee
Sponsor:
Istituto Ortopedico Rizzoli
Organization:
Istituto Ortopedico Rizzoli
Study Overview
Official Title:
Mid- and Long-term Evaluation of the Results of Patients Undergoing Spinal Cord Stimulation With Microfractures BST CarGel in the Treatment of Patellofemoral Chondral Lesions of the Knee
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARGEL-LT
Brief Summary:
The study consists of 3 phases Identification of eligible patients follow-up by telephone or telemedicine platform and the collection of study-specific clinical data of enrolled patients
Identification by trained medical personnel of subjects who meet the study inclusion criteria
Once the patients Informed Consent has been obtained the study-specific questionnaires will be submitted
Clinical score data will be collected from the questionnaires conducted at mid- and long-term follow-up of patients enrolled in the study The data collected during the long-term follow-up will be used to evaluate the time course of the results obtained after treatment of osteochondral lesions of the patellar cartilage by spinal cord stimulation with microfractures
Identification by trained medical personnel of subjects who meet the study inclusion criteria
Once the patients Informed Consent has been obtained the study-specific questionnaires will be submitted
Clinical score data will be collected from the questionnaires conducted at mid- and long-term follow-up of patients enrolled in the study The data collected during the long-term follow-up will be used to evaluate the time course of the results obtained after treatment of osteochondral lesions of the patellar cartilage by spinal cord stimulation with microfractures
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None