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

NCT ID: NCT06477315

Last Updated: 2025-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-22

Study Completion Date

2029-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chondral Lesion of the Knee Patellofemoral Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

post surgery patients

survey

Intervention Type OTHER

telephone surveys

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

survey

telephone surveys

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

References

Explore related publications, articles, or registry entries linked to this study.

Strauss EJ, Galos DK. The evaluation and management of cartilage lesions affecting the patellofemoral joint. Curr Rev Musculoskelet Med. 2013 Jun;6(2):141-9. doi: 10.1007/s12178-013-9157-z.

Reference Type RESULT
PMID: 23392780 (View on PubMed)

Duncan RC, Hay EM, Saklatvala J, Croft PR. Prevalence of radiographic osteoarthritis--it all depends on your point of view. Rheumatology (Oxford). 2006 Jun;45(6):757-60. doi: 10.1093/rheumatology/kei270. Epub 2006 Jan 17.

Reference Type RESULT
PMID: 16418199 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CARGEL-LT

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.