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 (CARGEL-LT)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Patellofemoral Disorder; Chondral Lesion of the Knee
• Intervention / Treatment: Other: survey

• Study Type: Observational
• Enrollment (Estimated): 15

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Istituto Ortopedico Rizzoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing treatment of osteochondral lesions of patellar cartilage by spinal cord stimulation with microfractures + BST CarGel

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
post surgery patients	Other: survey; telephone surveys

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Knee Documentation Committee	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.	baseline (post surgery)
Knee Injury and Osteoarthritis Outcome Score	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.	baseline (post surgery)
EuroQol visual analogue scale	It is a visual analogue scale that has a range of scores between 0 (worst imaginable health condition) and 100 (best imaginable health condition).	baseline (post surgery)
Tegner Score	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.	baseline (post surgery)
(EuroQoL) Current Health Assessment	valuable tool for measuring a patient's quality of life	baseline (post surgery)
Patient Acceptable Symptom State	Valuable tool for assessing patient satisfaction in view of their current degree of pain, function and daily activity	baseline (post surgery)
Final assessment of treatment	The patient should indicate satisfaction and the relative degree of satisfaction with the treatment after a minimum of 5 years after the infiltrative treatment.	baseline (post surgery)
failure question	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	baseline (post surgery)

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2023
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: June 21, 2024
• First Submitted That Met QC Criteria: June 21, 2024
• First Posted (Actual): June 27, 2024

Study Record Updates

• Last Update Posted (Actual): July 4, 2025
• Last Update Submitted That Met QC Criteria: July 3, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Fractures, Stress
• Other Study ID Numbers: CARGEL-LT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No