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

Active, not recruiting

• Conditions: Chondral Lesion of the Knee; Patellofemoral Disorder
• Interventions: Other: survey

• Registration Number: NCT06477315
• Lead Sponsor: Istituto Ortopedico Rizzoli

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-22
• Study First Submitted: 2024-06-21
• Study First Submitted QC: 2024-06-21
• Study First Posted: 2024-06-27
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03
• Primary Completion: 2029-07
• Study Completion: 2029-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
post surgery patients	survey	-

Primary Outcome Measures

Name	Time	Method
EuroQol visual analogue scale	baseline (post surgery)	It is a visual analogue scale that has a range of scores between 0 (worst imaginable health condition) and 100 (best imaginable health condition).
Tegner Score	baseline (post surgery)	allows one to estimate the motor activity level of a subject with a score between 0 and 10, where 0 represents 'inability' and 10 represents 'participation in competitive sports, such as football at national or international level. This score is the one most commonly used to define the motor activity level of patients with knee disorders.
Final assessment of treatment	baseline (post surgery)	The patient should indicate satisfaction and the relative degree of satisfaction with the treatment after a minimum of 5 years after the infiltrative treatment.
International Knee Documentation Committee	baseline (post surgery)	This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathologies. The questionnaire examines 3 categories: symptoms, sports activity and knee function. According to this questionnaire, a score between 0 and 100 can be obtained, whereby a high score is associated with a high level of function and minor pain symptoms. A score of 100 is in fact interpreted as a condition in which there are neither limitations in conducting activities of daily living nor symptoms.
Knee Injury and Osteoarthritis Outcome Score	baseline (post surgery)	The complete questionnaire consists of five subscales and covers: pain (9 items), symptoms (7 items of which two concern stiffness), functions and activities of daily living (17 items) physical function, sports and leisure activities (5 items) and quality of life in relation to the knee (4 items). All items of the relevant subscales have the same response mode, use a 5-point Likert scale and each question is assigned a score from 0 to 4, where 0 indicates "no difficulty" and 4 "severe difficulty".) Score range 0-100 for each subscale.
(EuroQoL) Current Health Assessment	baseline (post surgery)	valuable tool for measuring a patient's quality of life
Patient Acceptable Symptom State	baseline (post surgery)	Valuable tool for assessing patient satisfaction in view of their current degree of pain, function and daily activity
failure question	baseline (post surgery)	the patient should indicate whether and when a new infiltrative or surgical treatment was performed. Questions will also be asked about possible complications and re-interventions

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy