Clinical trial NCT06477315: 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
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chondral Lesion of the Knee
Patellofemoral Disorder
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing treatment of osteochondral lesions of patellar cartilage by spinal cord stimulation with microfractures + BST CarGel

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 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


Eligibility criteria: 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

Primary outcomes:
measure: International Knee Documentation Committee
timeFrame: baseline (post surgery)
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: baseline (post surgery)
measure: EuroQol visual analogue scale
timeFrame: baseline (post surgery)
measure: Tegner Score
timeFrame: baseline (post surgery)
measure: (EuroQoL) Current Health Assessment
timeFrame: baseline (post surgery)
measure: Patient Acceptable Symptom State
timeFrame: baseline (post surgery)
measure: Final assessment of treatment
timeFrame: baseline (post surgery)
measure: failure question
timeFrame: baseline (post surgery)
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
References:
citation: 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.
citation: 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.