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

NCT06477315 | Active Not Recruiting

• 1 other identifier: CARGEL-LT
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Chondral Lesion of the Knee; Patellofemoral Disorder

Outcome Measures

Primary Outcomes (8)

• 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)

Study Arms (1)

post surgery patients

Other: survey

Interventions

survey OTHER

telephone surveys

post surgery patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Patients no longer available;
• Patients who do not agree to undergo assessment;
• Deceased patients

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (2)

• 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.

  PMID: 23392780 RESULT

• 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.

  PMID: 16418199 RESULT

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: June 27, 2024
• Study Start: September 22, 2023
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: July 4, 2025

Record last verified: 2025-07

Locations

IT (1)