Mid- and Long-term Evaluation of the Results of Patients Undergoing Spinal Cord Stimulation With … (NCT06477315) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
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
Italy15 participantsStarted 2023-09-22
Plain-language 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 patient's 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
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female patients, aged between 18 and 75 years;
* BMI up to 30 kg/m2;
* Patients without subsequent surgery on the patellofemoral cartilage of the knee undergoing treatment;
* Ability and consent of patients to actively participate in the rehabilitation protocol and clinical and radiological follow-up;
* Signature of informed consent
* availability
* Competent patients
Exclusion Criteria:
* Patients no longer available;
* Patients who do not agree to undergo assessment;
* Deceased patients
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.